Malaysia as the preferred global manufacturing and ...

Malaysia as the preferred global manufacturing and services location for medical technology

ANNUAL REPORT

20192019

CONTENTS

Chairman’s Message

AMMI Board of Directors and Secretariat Team

AMMI Committees

Policy Advocacy

Talent Development

Operational Excellence

Medtech Technology Industry Development

Membership Activities

AMMI Members’Directory

02 04 05

06 18 23

25 27 33

AMMI ANNUAL REPORT 201902

Dear MembersThis year marks AMMI’s 30th Anniversary in Malaysia.

We have indeed come a long way – from 6 founding members - to currently 74 members. Since its inception 30 years ago, AMMI has spearheaded the development of the medical device industry and its eco-system.

AMMI member companies continue to be the growing base of the medical device industry in Malaysia. Indeed, AMMI is the recognised voice in the Medical Technology industry by driving balanced policy advocacy.

In September 2019, we conceptualised AMMI Strategic Roadmap 2025, which will provide us with the blueprint moving forward. Our vision is to make Malaysia the preferred location for global manufacturing and services in medical technology.

We remain focused on our mission to promote and strengthen manufacturing and services operational excellence in Malaysia through our strategic pillars of:• policy advocacy,• talent development,• operational excellence and• medical technology industry development.

Moving forward, our policy advocacy work will focus on identifying key messages to advocate for the benefit of the medical technology industry. Some of the key areas are:• Facilitate access to local and export markets• Advocate globally competitive incentives for

investment and reinvestment • Share technical expertise to help shape policy

development• Support the harmonisation of regulatory

frameworks worldwide• Collaborate with global medical technology

industry associations.

CHAIRMAN'S

MESSAGE


With the growth of the medical device industry, talent development remains an important pillar to support the continuous development of a skilled and adaptable workforce. We will put more efforts to achieve talent development objective of facilitating the transfer and sharing of knowledge within our industry through the implementation of the Medtech training and global expert knowledge sharing. The HR leaders’ roundtable will focus on increasing awareness of opportunities in the medical technology sector through proactive collaboration with higher education institutes.

For Malaysia to remain competitive, we need to improve operational excellence industry-wide. We aim to build upon operational expertise through the following initiatives:• Cross-industry benchmarking • Education sessions with key technology

providers.• Sharing sessions with industry leaders.

To achieve our vision in 2025, AMMI will work closely with key government agencies on the pillar of medical technology industry development.

AMMI will facilitate new start-ups and growth in the medical device industry and expand value-chain capabilities in Malaysia. To do this, let me outline our key strategies as follows: • Expand and strengthen the local supply base

for the medical device industry. • Provide structured support and information

sharing to potential investors.• Analyse and publish medical device industry

data.

As iron sharpens iron, I believe AMMI members will achieve manufacturing excellence by focusing on key matters and spurring exchanges of insightful knowledge. Collectively, we will be able to shape the landscape of the medical device industry in 2025, for the benefit of all involved.

Last but not least, I would like to thank the Board of Directors and members for their active engagement and valuable contribution to the progress of the association.

Together, we win.CHRISTOPHE MARQUEChairman December 31, 2019

Malaysia as the preferred global manufacturing and services location for medical technology

Promote and strengthen manufacturing and services operational excellence in Malaysia through our strategic pillars

MISSION

VISION

STRATEGIC PILLARS

Pillar 3OPERATIONALEXCELLENCE

Pillar 2 TALENT

DEVELOPMENT

Pillar 1POLICY

ADVOCACY

Pillar 4MEDICAL

TECHNOLOGY INDUSTRY

DEVELOPMENT

AMMI ANNUAL REPORT 201904 AMMI BOARD OF

DIRECTORS

VICE-CHAIRMANMr John Ward

SteriPack Contract Manufacturing

DIRECTORMr Dave Mitchell

Boston Scientific Medical Device (Malaysia) Sdn Bhd

HEAD OF MARKETING &COMMUNICATIONSMs Melissa Khoo

VICE-CHAIRMANMr Andy Lee

Johnson & Johnson Sdn Bhd

TREASURERMr Michel Van Crombrugge

Paramit Malaysia Sdn Bhd

DIRECTORMr André Holzhausen

B.Braun Medical Industries Sdn Bhd

DIRECTORDr Yuma Konishi

Texchem Life Sciences Sdn Bhd

HEAD OF ADMINMs Heng Ee Ling

CHAIRMANMr Christophe Marque

Stereo Sdn Bhd

SECRETARY-GENERALY.Bhg. Dato’ Dr. Hj. Haminnuddin

Hj. Abd. HamidIdeal Healthcare Sdn Bhd

DIRECTORMr Samuel

PooranakaranCochlear Malaysia Sdn Bhd

EXECUTIVE DIRECTORMr Ching Choon Siong

RETIREMENTS ANDRESIGNATIONS

• Mr Yap Kee Keong (Texchem Group) Vice-Chairman, retired June 2019• Mr Eow Hu Teik (Abbott), Secretary-General, retired June 2019• Mr Paul Brandeis (B.Braun Medical Industries) Treasurer, until January 2019• Mr Tom Mangan (CR Bard), Director of the Board, until January 2019

SECRETARIAT TEAM


GOVERNMENT AFFAIRS AND POLICY COMMITTEE Co-opted Members

Leader: Mr Andy Lee Kuan Min (Johnson & Johnson) Mr Hitendra Joshi (B.Braun Medical Industries)

Dr Yuma Konishi (Texchem Life Sciences) Dr Ashok Krishna Perumal (B.Braun Medical Industries)

Y.Bhg. Dato’ Dr Hj. Haminnuddin Hj. Abd. Hamid (Ideal Healthcare)

Mr Dave Mitchell (Boston Scientific)

Mr Samuel Pooranakaran (Cochlear)

TALENT DEVELOPMENT COMMITTEE Co-opted Members

Leader: Dr Yuma Konishi (Texchem Group) Mr Eow Hu Teik (Abbott)

Mr Michel Van Crombrugge (Paramit) Mr Ben Ong (B.Braun Medical Industries)

Ms Tan Lin Im (Teleflex)

Ms Suriati Binti Abdul Samad (Paramit)

REGULATORY AND TECHNICAL COMMITTEE Co-opted Regulatory Group

Leader: Y.Bhg. Dato’ Dr Hj. Haminnuddin Hj. Abd. Hamid Ms Seow Lan Hoon (Ansell)

(Ideal Healthcare) Ms Quek Lang Fah (B.Braun Medical Industries)

Mr Samuel Pooranakaran (Cochlear) Ms Grace Wong (Johnson & Johnson)

Mr Dave Mitchell (Boston Scientific) Ms Chuah Chiew Teng (3M Malaysia)

Ms Nur Aqilah (Terumo)

Co-opted Technical Group Ms Queenie Lee Ching Hoay (KLS Martin)

Ms Gan Poh Siew (Haemonetics) Mr Jason Ng (UWC Healthcare)

Mr Khor Siek Meng (Ansell) Mr Juzaili Jamil (Ideal Healthcare)

Mr Gobu A/L Devarajan (Ansell) Ms Karen Lai (SteriPack)

Ms Kek Soo Ling (Abbott) Ms Valerie Lim (Smith & Nephew)

Ms Koh Seok Ling (Ambu) Ms YY Lee (Medtronic)

Ms Yoke Fang (Cochlear)

MEMBERSHIP COMMITTEE

Leader: Mr John Ward (SteriPack Contract Manufacturing)

Co-Leader: Mr Samuel Pooranakaran (Cochlear)

Mr Christophe Marque (Stereo)

Mr Michel Van Crombrugge (Paramit)

Co-opted Members

Mr Hitendra Joshi (B.Braun Medical Industries)

AMMI

COMMITTEES

AMMI has continued to play an integral role in the following organisations:

Member, Medical Devices Investment Advisory Panel, Malaysian Investment Development Authority (MIDA). Member, MIDA Medical Devices Human Capital Committee.

Member, Industry Standards Committee on Medical Devices and Facilities for Healthcare, Malaysian National Standards Committee, Malaysian Standards and Accreditation Council, Department of Standards Malaysia.

Member, High Impact Programme (HIP) 5: Medical Devices Initiative Steering Committee, SME Corp Malaysia.

Associate Member, Asia Pacific Medical Technology Association (APACMed).

A recognised voice in the Medical Technology industry by driving balanced policy advocacy.

POLICY

ADVOCACY

06

Highlight of advocacy success: • MOH's acceptance of the proposed

amendment of the Medical Device Act to exclude the word "export" from the Act.

Key advocacy actions: • Draft Malaysian Standard: Halal

Medical Device • AMMI Recommendation Paper for

the 12th Malaysian Plan • Budget 2020

In recognition of AMMI’s position as the voice of medical device industry, Mr Hitendra Joshi, former Chairman of AMMI, was appointed representative of AMMI to sit in the Board of Medical Device Authority (MDA) effective from 2 January 2019 – 31 December 2020.

As representative of AMMI, Y.Bhg. Dato’ Lee Kim Meow (KM Lee), Managing Director of Top Glove Corporation Bhd, has been appointed as Member of the Board of Trustees, Malaysian Rubber Export Promotion Council (MREPC).


Government Affairs and Policy Committee

POLICYADVOCACY

Work related to the Draft Malaysian Standard: Halal Medical Device

14 January

Halal Medical Devices Working Group Meeting

22 January

AMMI wrote to: • the Hon. Minister of Health• the Hon. Minister of International Trade and

Industry • the Hon. Deputy Minister of Health • the Hon. Deputy Minister of International

Trade and Industry• the Secretary General, Ministry of Health

(MOH)• the Secretary General, Ministry of International

Trade and Industry (MITI)

26 February

Meeting with the Hon. Dr Lee Boon Chye, Deputy Minister of HealthMr Andy Lee (AMMI Vice-Chairman), Mr Ching Choon Siong (AMMI Executive Director), Dr Ashok Perumal (Committee Member), Mr Azhan Mokhtar (Committee Member) represented AMMI.

7 March

8 April

AMMI wrote to: • the Director General, Department of Islamic Development (JAKIM) • the Director General, Department of Standards

Dialogue Session chaired by Y. Bhg. Datuk K. Talagavathi, Deputy Secretary General (Industry), MITI.Mr Andy Lee (AMMI Vice-Chairman), Dr Ashok Perumal (Committee Member) and Mr Azhan Mokhtar (Committee Member) represented AMMI.



POLICYADVOCACY

Work related to the Draft Malaysian Standard: Halal Medical Device

12 April

AMMI wrote to: • the Economic Advisor to the Prime Minister of Malaysia • Y.Bhg. Datuk K. Talagavathi, Deputy Secretary General, MITI

28 May

20 June

Meeting chaired by YBhg. Dato’ Abdul Majid Ahmad Khan, Chairman of MIDAMr Dave Mitchell (AMMI Director), Mr Samuel Pooranakaran (AMMI Director) and Mr Ching Choon Siong (AMMI Executive Director) represented AMMI.

Mr Andy Lee (AMMI Vice-Chairman), Mr Samuel Pooranakaran (AMMI Director) and Dr Ashok Perumal (Committee Member) represented AMMI.

21 June

AMMI wrote to: • the Chief Secretary to the Government of Malaysia (KSN) • the Economic Advisor to the Prime Minister of Malaysia • the Secretary General, Ministry of Health (MOH)

18 July

The Hon. Minister of International Trade and Industry approved the declaration of Malaysian Standard (MS 2636): Halal Medical Device – General Requirements

7 November

The Department of Standards organized the Seminar on Halal Medical DeviceMr Ching Choon Siong represented AMMI.

After three years of discussion and engagement with various stakeholders, the Malaysian Government approved the Malaysian Standard (MS): Halal Medical Device – General Requirements (MS 2636:2019) on 18th July 2019 for the purpose of Halal certification on medical devices by the Halal competent authority in Malaysia, Department of Islamic Development Malaysia (JAKIM) or the respective State Islamic Religious Councils.

Halal certification on medical device is not mandatory in Malaysia. All medical devices must comply with the Malaysian Medical Device Act 2012 (Act 737) before they can apply for halal certification from JAKIM.



POLICYADVOCACY

Preparation of the 12th Malaysian Plan (RMK-12) (2021-2025)

Our advocacy actions:

AMMI RECOMMENDATION PAPER FOR THE 12TH MALAYSIAN PLAN

Mr Andy Lee, Mr Dave Mitchell (AMMI Director) and Mr Ching Choon Siong represented AMMI. The Hon. Minister of Health made a presentation on the proposed National Healthcare Reform. AMMI submitted a recommendation paper to the government.

First Meeting of the Technical Working Group (TWG) for Manufacturing – Medical Devices Industry Focus Group • AMMI was appointed as Co-Chair of the Focus Group. • Mr Andy Lee (AMMI Vice-Chairman) represented AMMI.

25July

31July

15August

Second Meeting of the Technical Working Group (TWG) for Manufacturing – Medical Devices Industry Focus Group Mr Andy Lee, Mr Samuel Pooranakaran (AMMI Director), Mr André Holzhausen (AMMI Director) and Mr Ching Choon Siong (AMMI Executive Director) represented AMMI.

RMK-12 Healthcare Sector Preparation Convention and Third Meeting of the Technical Working Group (TWG) for Manufacturing – Medical Devices Industry Focus Group

1. Recommendation:

Proposal of the MedTech Career Expo with the objectives of increasing visibility of the medical devices industry, setting up medical device showcase and MedTech’s Got Talent programme. The expo, aimed at undergraduates, should comprise of job fair (talent scouting), product/ technology exhibition and factory visits.

Standardised internship duration of 6 months. Based on the successful track record of the AMMI Medtech Programme implementation for graduates and industry professionals from 2014-2018, AMMI as the industry association would be more effective and efficient in organising talent development programmes.

Ease of Professional Visit Pass (PVP) application and removal of Withholding Tax. This is to facilitate the invitation of foreign experts to Malaysia for technology transfer, training of local staff, equipment set-up, maintenance and repair.

Human Capital Development



POLICYADVOCACY



2.

3.

4.

5.

Recommendation:

Review of R & D incentives to make it attractive for companies to bring more in more R & D activities into the country. Incentives should be extended to approved R & D, test & research centres and must include human resources and IP (Intellectual Property) costs. Cost of joint research with universities and research centres should further be encouraged through the provision of grants.

Defined vision for an ecosystem in Malaysia together with a development roadmap.

Recommendation:

Public funding mechanism should focus on Industry 4.0 infrastructure and ecosystem. It should support showcase and lighthouse projects and factories.

Recommendation:

Strategic collaboration between MITI, MIDA, SMECorp and industry associations (AMMI and MARGMA) to business-match innovative local companies with large companies.

Recommendation:

Existing HIP5 programme by SMECorp can be further enhanced by increasing the matching grant from current RM200,000 to RM1,000,000. Limit and define focus areas of value creation such as: • Sterilization • Traceability • Documentation and data analytics • Material sustainability • Connectivity • Test and validation • Clinical trial and studies

Recommendation:

Harmonisation agenda to be driven by MITI and MDA, in consultation with other ASEAN member states.

Innovation

Creation of global champions among Malaysian SMEs

6.

Non-tariff Barriers and Regulatory

Compliance

Local Supply Chain and Opportunities for Collaboration

between SMEs and MNCs

Industry 4.0- Moving into automation

AMMI ANNUAL REPORT 201911POLICY

ADVOCACY




7.

8.

9.

10.

11.

Recommendation:

Make Malaysia an attractive place for European companies to conduct clinical trials here in compliance with the new EUMDR. The focus should be on building Malaysian as the Hub of Clinical Trials with a complete ecosystem around it.

Recommendation:

New incentives and co-funding to attract reputable companies to set up own testing labs in Malaysia to support development of an ecosystem.

Proposal:

Setup of the Medical Device Information Platform, with funding allocation to the Medical Device Authority, based on the model of National Property Information Centre (NAPIC) (https://napic.jpph.gov.my/)

Recommendation:

• Transparent procurement process• Clear guidelines on the definition of Made-In-Malaysia (% of local

content)• Provide proof that the company is the true manufacturer of the product,

and not just labelling semi-finished or fully finished products as Made-in-Malaysia. Companies have to provide evidence of the value-add processing that is being done in Malaysia for their products.

• Tax on semi-finished goods and no tax for local components (raw materials)

• Start with the registration list under the Medical Device Authority (MDA) as a reference point to determine the status of a company as a local manufacturer

• Ensure that manufacturers on the MDA reference list are true local manufacturers that conduct majority of value-added processing in Malaysia (i.e. not just manufacturers that import semi to fully finished goods and relabelling)

• Conduct compliance audits on manufacturers based on above point• Impose penalty for non-compliance

Recommendation:

AMMI would like to suggest to the Federal Government of Malaysia to give due consuderation for Malaysia to become a signatory to the WTO - GPA.

Hub for Clinical Trials

Lack of comprehensive

GLP Labs

Medical Device Ecosystem

Information Platform

Transparency in Public

Procurement of Medical Devices

WTO – Government Procurement

Agreement (GPA)

AMMI ANNUAL REPORT 201912 POLICY

ADVOCACY


Work related to Budget 2020

Withholding Tax and Professional Visit Pass

The current Professional Visit Pass (PVP) procedure is bureaucratic and makes it difficult to bring in industry experts from overseas to Malaysia to train local employees. In addition, the visiting experts are subjected to withholding tax, although they are not under the Malaysian payroll. This prevents them from coming to Malaysia, thus affecting the training/ upskilling of local talent, especially in niche/ high-tech areas where local experts are not available. affect the training/ upskilling of local talents, especially in niche/ high tech areas where local experts are not available.

Ease of Professional Visit Pass (PVP) application and removal of withholding tax to facilitate the invitation of foreign experts to Malaysia for technology transfer, training of local staff, equipment set-up, maintenance and repair.

Alternate recommendation: Introduction of new Expert Pass with no withholding tax.

The new Expert Pass should be processed by MIDA and issued by Immigration Office based in MIDA.

6 September

Budget 2020 Focus Group with the Hon. Minister of Finance and the Hon. Minister of HealthMr Christophe Marque (AMMI Chairman), Mr Andy Lee (AMMI Vice-Chairman), Mr Dave Mitchell (AMMI Director), Mr Ching Choon Siong (AMMI Executive Director) and Dr Ashok Perumal (B. Braun) represented AMMI.

Mr Marque presented on the following issues and recommendations:

Issue No 1

Description

Recommendation

R&D Incentives

Incentives for in-house R & D activities in Malaysia are based on an outdated paradigm. The incentives are limited to qualifying capital expenditure with no regard for intellectual assets. The incentives remain unattractive to companies that are engaged both in R & D and manufacturing in Malaysia.

Review of R & D incentives to make it attractive for companies to bring more R & D activities to the country. The incentives should be extended to approved R & D, test & research centres and must include human resources and IP (Intellectual Property) costs. Cost of joint research with universities and research centres should further be encouraged through the provision of grants.

Issue No 2

Description

Recommendation


Transparency in Public Procurement of Medical Devices

The existing procurement model has raised the cost of the public healthcare system by not allowing for direct sales of medical products to government hospitals.

Local medical device manufacturers and MNCs have invested billions over the past decades, provided job opportunities to many thousands, spurred local innovation via the transfer of technology and yet they are unable to secure appropriate tender volume albeit lower prices while producing products according to global quality standards.

Review direct sales channel for government procurement to reduce cost and increase access to healthcare.

Reinvestment Incentives

Malaysia’s incentives strategy for reinvestment is not globally competitive in comparison with other medical device clusters such as Costa Rica and Ireland. Other countries are leap frogging in technology and the value chain with a clear and consistent incentive strategy.

Reinvestment incentives should be consistent with those provided for initial investment. The reinvestment incentives are needed to continue to attract high technology FDI and innovation in medical device space.

POLICYADVOCACY


Work related to Budget 2020

Our engagement with the Ministry of International Trade and Industry (MITI)

12 September

3 October

15-16 October

MITI Consultative Dialogue LaunchingMr Andy Lee (AMMI Vice-Chairman) and Mr Hitendra Joshi (committee member) represented AMMI.

MITI Consultative Dialogue with AMMI Mr Andy Lee and Y.Bhg. Dato’ Dr Hj Haminnuddin bin Hj Abd. Hamid (AMMI Secretary-General) represented AMMI.

MITI Joint Ministerial Dialogue Session Mr Andy Lee and Mr Ching Choon Siong (AMMI Executive Director) represented AMMI.

Issue No 4

Description

Issue No 3

Description

Recommendation

Recommendation


Our engagement with the Malaysian Investment Development Authority (MIDA)

POLICYADVOCACY


23 January

29 March

5 November

MIDA Medical Device Human Capital Committee Meeting in Kuala Lumpur MIDA and AMMI agreed in principle to work together as partners to build a sustainable talent pipeline for the medical device industry through talent development programmes and collaborations with universities and other stakeholders. The meeting was attended by Mr Christophe Marque (AMMI Chairman), Mr Yap Kee Keong (Vice-Chairman and Leader of Talent Development Committee), Mr Eow Hu Teik (AMMI Secretary-General), Mr Ching Choon Siong (AMMI Executive Director), Mr Kamales (General Manager of Vigilenz), Mr Andrew Anthony (Group HR Manager of ITL Asia Pacific) and Ms Khaw Teoh Su Ping (HR Senior Manager of Texchem).

MIDA Medical Device Human Capital Committee Meeting in Penang Mr Ching Choon Siong, Ms Chee Wei Bee (Talent Development Consultant), Ms Cynthia Ooi (Texchem), Ms Suriati Abdul Samad (Paramit), Ms Kellie Kueh (B. Braun), Mr Jason Ng (UW Healthcare), Mr Loh Kah Heng (Integer), Mr Zainuddin bin Mashood (Ain Medicare), Ms Joyce Ong (Boston Scientific) and Dr Khaw Juan Shong (CCB Medical Devices) represented AMMI in the meeting.

The topics discussed were MedTech Career Expo, Internship, Medtech Certification Programme, HRDF levy for overseas experts and exemption of withholding tax for foreign trainers.

MIDA Medical Device Investment Advisory Panel (MDIAP) Meeting in Kuala Lumpur Mr Ching Choon Siong represented AMMI in the meeting. AMMI presented the following topics for discussion: • Withholding tax • Professional Visit Pass• Increase of internship period to six months • Review of R&D Incentives

• New incentives for attracting companies to set up new testing labs

• Consistency of Reinvestment Incentives/Tranches of Incentives

• WTO – Government Procurement Agreement (GPA)


Work related to Notification of Export Only Medical Device and proposed amendment of the Medical Device Act to exclude export regulation.

POLICYADVOCACY

Regulatory Affairs and Technical Committee

AMMI Members’ Feedback Submission to MDAThe submission covered two main areas - (1). business aspect – burden to export and additional cost (2) technical aspect – content of GD does not cover all business models of medical device exportation hence not practical.

AMMI submitted a policy paper to the Ministry of Health for proposing amendment of the Medical Device Act to exclude the word “export” from the Act.

Meeting on Draft Guidance Document: Notification of Export Only Medical DeviceMs Seow Lan Hoon represented AMMI.

Notification of Export Only Medical Device

Meeting on Draft Guidance Document: Notification of Export Only Medical DeviceY.Bhg. Dato’ Dr Hj. Haminnuddin bin Hj. Abd. Hamid, Ms Seow Lan Hoon and Ms Quek Lang Fah (Committee Member from B. Braun) represented AMMI in the meeting.

Meeting on Draft Guidance Document: Notification of Export Only Medical DeviceY.Bhg. Dato’ Dr Hj. Haminnuddin bin Hj. Abd. Hamid (AMMI Secretary General and Leader of the Committee), Ms Seow Lan Hoon (Committee Member from Ansell) and Ms Karen Lai (Committee Member from SteriPack) represented AMMI in the meeting.

Details of the policy: Effective 16 July, licensed establishment, contract manufacturer or authorized exporter who is responsible for exporting the medical device shall apply for the Notification of Export Only Medical Device with one notification application made for only one single medical device nomenclature. The validity period of the Acknowledgement on Notification for Export Only Medical device is five (5) years.

What is the issue? As the importing country’s medical device regulator will regulate the medical devices produced from Malaysia, the application process and fee of the Notification of Export Only Medical Device is an extra regulatory burden to the industry. Globally, the practice of medical device regulator is to regulate and safeguard the public interest of the medical devices that enter the market of the home country.

Our advocacy actions:

11 February

21 February

11 March

28 June

3 July

16 July



POLICYADVOCACY

MDA Regulatory Committee Stakeholders’ Engagement Session The MDA Regulatory Reform Committee was established to study and make the necessary recommendations to the Board of MDA for improving the regulatory framework by the end of 2019. The main scope of the regulatory reform is to propose the necessary amendments of the Act 737 in 2020.

In line with the regulatory reform, AMMI proposed the amendment of the Medical Device Act to exclude the word “export” from the Act 737.

25 September

Medical Device Industry Town Hall with the Hon. Minister of HealthAMMI Executive Director Mr Ching Choon Siong presented the proposal to amend the Medical Device Act to exclude the word “export” from the Act.

The main objectives of AMMI’s proposal are to: • enhance the competitiveness of Malaysia as the destination of medical

device manufacturing for exporting to the global market; • reduce the regulatory burden for all stakeholders to promote the export

of medical devices from Malaysia.

The Hon. Minister of Health and the Secretary General of the Ministry of Health and CEO of MDA collectively agreed in principle to AMMI’s proposal.

MDA Regulatory Reform Committee has agreed with the proposed amendment of the Medical Device Act to remove export regulation.

26 November

16 October

Results and impact: With the amendment of the Act 737 to exclude “export” in year 2020, medical device manufacturers will benefit with the reduced regulatory burden in exporting the Made-in-Malaysia medical devices to global markets.

Work related to Notification of Export Only Medical Device and proposed amendment of the Medical Device Act to exclude export regulation

Our engagement with the Medical Device Authority (MDA) and its MDA-Industry Collaborative Committee (MICC) and MDA Workshops

Background: The MDA-Industry Collaborative Committee (MICC) was established as the platform to discuss the common issued faced by the medical device industry and foster collaboration between MDA and the industry. The MDA Chief Executive will be the Chair while a representative from the medical device industry association will be the Co-Chair of the MICC.



POLICYADVOCACY

Our engagement with the Medical Device Authority (MDA) and its MDA-Industry Collaborative Committee (MICC) and MDA Workshops

28March

15April

29May

12June

23 September

15-16October

MDA Workshop on Policy, Guidance Document and Industry Support• The workshop covered re-registration, change notification, establishment licensing, post-

market surveillance and vigilance; and notification of export only medical device.• Ms Grace Wong (Committee Member from Johnson & Johnson), Ms Quek Lang Fah, Ms

Ng Yoke Yin (Committee Member from Ansell), Ms YY Lee (Committee Member from Medtronic), Ms Valerie Lim (Committee Member from Smith & Nephew), Mr Fong Suit Kook (Committee Member from ITL) represented AMMI.

MICC Meeting #1• The meeting covered change notification, license renewal, revisited labelling requirements,

clarity on regulatory enforcement, combination device, ASEAN regulations collaborator, Customs clearance, clarity on import / export Customs requirements.

• Ms Grace Wong, Ms Seow Lan Hoon, Ms Quek Lang Fah and Mr Jason Ng (Committee Member from UW Healthcare) represented AMMI.

MDA Workshop on the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products• Ms Quek Lang Fah and Ms Valerie Lim represented AMMI.

MDA Buka Puasa with the Hon. Minister of Health• Mr Samuel Pooranakaran (AMMI Director) represented AMMI.

MICC Meeting #2• Matters discussed were the upcoming International Medical Device Conference (IMDC)

and Malaysia Medical Device Expo (MYMEDEX), Town Hall with the Hon. Minister of Health, change notification, registration renewal, medical device labeling and combination device.

• MDA was also requested to involve the associations in the meeting with Customs to ensure smooth import and export of medical devices

• The fees for export-only medical device has been approved by the MDA Board and the acknowledgment letter is valid for 5 years.

• Ms Seow Lan Hoon and Ms YY Lee represented AMMI.

MICC Meeting #3• Discussion continued on combination products, change submission, Medcast 2.0 and

payment method, labelling requirements, Customs requirements / restriction order, re-registration and change submissions.

• Ms Grace Wong and Ms Seow Lan Hoon represented AMMI. Ms Seow co-chaired the MICC meeting.

International Medical Device Conference (IMDC) • Mr Andy Lee (AMMI Vice-Chairman) and Mr Ching Choon Siong (AMMI Executive Director)

represented AMMI.

18February

18

AMMI Medtech Certification Programme

With the excellent track record and feedback received from the certified participants of the 2018 AMMI Medtech Certification Programme, AMMI will continue to roll out the medtech programmes to meet the demand of the medical device industry. In 2019, AMMI Medtech Certification Courses have obtained approval for co-funding under the Industry Certification (INDCERT) scheme by the Human Recourses Development Fund (HRDF). The programme is target for roll-out in 2020.

TALENT

DEVELOPMENT

Training Courses

10Trainees346 Global Expert

Sharing Sessions

2Trainees121

1. Medtech Quality Professional Course (22 days)

2. Medtech Manufacturing Excellence Course (21 days)

4. Medtech Regulatory Compliance Course (10 days)

3. Medtech Technical Competency Course (22 days)

5. Medtech Upskilling Course (10 days)

Support continuous development of a skilled and adaptable workforce, increase awareness of opportunities in the medical technology sector and facilitate the transfer and sharing of knowledge within our industry.

AMMI ANNUAL REPORT 201919TALENT

DEVELOPMENT

19 September

AMMI HR RoundtableTwenty HR professionals from AMMI member companies attended the event held at G Hotel Gurney. Dr Yuma Konishi, (Texchem) AMMI Director of the Board and Leader of the Talent Development Committee, led the roundtable discussions. The objective of the roundtable was for all HR leaders of AMMI member companies to come together to create a stronger voice in championing common issues and chart strategic agenda.

9 April

Medical Device Packaging, E&O Hotel, Penang

66 Mr Dan Floyd, DuPont21

No of participants No of companies Trainer

20-21 March

ISO13485:2016 Quality Management System, Hilton, Petaling Jaya

18

Mr Tony Low

8

AMMI ANNUAL REPORT 201920 TALENT

DEVELOPMENT

17-18 April

Risk Management for Medical Device, Dorsett Grand Subang

15

Mr Harry Wong

12


23 April

Medical Device Usability, G Hotel Kelawai, Penang

47 Mr Merrick F Kossack12

25 April

Labelling for Medical Device, G Hotel Kelawai, Penang

53 Mr Tony Low17


19-20 June

Software Validation Requirements and Excel Spreadsheet Validation, G Hotel Kelawai, Penang

46 Mr Gobu Devarajan13

31 July

TALENTDEVELOPMENT

Global Expert Sharing on “Sterile Medical Packaging: Regulations, Standards, Design & Development and Validations”, G Hotel Kelawai, Penang

73 Mr Thierry Wagner, Regulatory Affairs Director for Europe, Middle-East & Africa at DuPont Medical and Pharmaceutical Protection

25


21-22 August

Medical Device Manufacturing Process Validation, G Hotel, Gurney, Penang

35

Mr Gobu Devarajan

15

AMMI ANNUAL REPORT 201922 TALENT

DEVELOPMENT

27-28 August

Effective Complaint Handling for Medical Devices, G Hotel Gurney, Penang

12

Mr Frank Ried

20-21 November

EU Medical Device Regulations Workshop, CCEC, Bangsar South, Kuala Lumpur

24

Dr Vincent Lam, TUV SUD

13

16 October

Global Expert Sharing on EU Medical Device Regulations, G Hotel Kelawai, Penang

48

22

Mr Thomas Stefan Brand, Vice President Quality Management for Non-active Medical Devices, Hospital Care Division, B. Braun Melsungen, Germany provided participants with the insight into major challenges of the new EU MDR, its impact on medical device manufacturers, and how organizations can prepare to ensure a smooth transition.

10 December

EtO Sterilization, G Hotel Gurney Penang

30

Encik Roslan Azman

13


7

Improve operational excellence industry-wideAMMI’s key initiative is to build operational expertise via cross-industry benchmarking, education sessions with key technology providers and sharing sessions with industry leaders.

OPERATIONAL

EXCELLENCE

17 January

Manufacturing Excellence Group MeetingMembers of the AMMI Manufacturing Excellence Group visited Paramit. The visit was hosted by Michel Van Crombrugge.

5 September

Biocon Factory Visit by AMMI members, JohorThirty AMMI members joined the exclusive visit to Biocon Sdn Bhd, Asia’s largest integrated insulins manufacturing facility at the Biotech Park in Johor.

23

AMMI ANNUAL REPORT 201924 OPERATIONAL

EXCELLENCE

26 August

Osram Factory TourThirty AMMI members joined an exclusive plant tour at Osram Kulim to get insight into the application of Industry 4.0 in a manufacturing facility. This was the first-ever cross-industry benchmarking visit organised by AMMI and hopefully more to come.

26 August

Industry 4.0 WorkshopForty-eight AMMI members and guests members attended the Industry 4.0 Workshop at The Light Hotel. MPDV and Rockwell Automation provided con-current demo sessions for the attendees.

Facilitate new start-ups and growth in the medical device industry and expand value-chain capabilities in Malaysia.

MEDICAL TECHNOLOGY

INDUSTRY DEVELOPMENT

25

27-31 January

5 March

Japan ASEAN Taiwan CEO Network Enhancing Project, TokyoMr KW Poh (Texchem Life Sciences), Mr Mohd Heerwan (Ideal Healthcare), Mr Ching Choon Siong (AMMI Executive Director), Mr Stanly Goh (CCB Medical Devices), Mr Maxx Lee (Professional Tools & Dies) attended the business matching and networking trip.

Meeting with Invest Penang and Smith & NephewMr Ching Choon Siong (AMMI Executive Director), presented the Overview of AMMI and the Medical Device Industry during the meeting.

To drive industry growth - expand and strengthen the local supply base for the medical device industry, provide structured support and information sharing to potential investors; analyse and publish medical device industry data.

KEYINITIATIVE

AMMI ANNUAL REPORT 201926 MEDICAL TECHNOLOGY

INDUSTRY DEVELOPMENT

21 June

AMMI Hosted the SME Support Japan Delegates in Kuala LumpurThe agenda was to discuss the sponsored trip to Bangkok for the CEO Networking Event during Medical Devices ASEAN 2019 and planning for the 2020 Japan-ASEAN CEO Networking Event in Japan. Mr Katsuhisa Takiguchi and Mr Nobutaka Kimura from SME Support Japan, Mr Ching Choon Siong (AMMI), Mr Stanly Goh (CCB Medical Devices) and Mr Poh Kok Wee (Texchem Life Sciences) attended the meeting.

5 July

Taiwan Healthcare Technology SeminarThe event was organised by the Ministry of Health and Welfare, Taiwan (R.O.C) at Setia SPICE Convention Centre, Penang. Mr Ching Choon Siong (AMMI) delivered the opening remarks and presentation about AMMI and the Medical Device Industry in Malaysia.

10-12 July 5 December

Bangkok Trip for AMMI Members to attend SME Support Japan-CEO Networking Event during Medical Devices ASEAN 2019Mr Stanly Goh (CCB Medical Devices), Mr Tan Kok Ang (Gem Impression), Mr Ooi Chee Keong (Prodelcon) and Mr Soh Swee Hua (Tecomet) attended the sponsored trip by SME Support Japan.

Launch of the AMMI Medical Device Industry Status and Outlook 2019/2020Mr Christophe Marque presented the AMMI Medical Device Industry Status and Outlook Report 2019/2020 to Encik Mohamad Ismail Abu Bakar, MIDA Executive Director (representing MIDA CEO, Dato' Azman Mahmud) during the AMMI 30th Anniversary Dinner.

AMMI ANNUAL REPORT 201927MEMBERSHIP

ACTIVITIES

6 March

AMMI Q1 Meeting and CEO Networking, Majestic Hotel Kuala Lumpur.Over fifty AMMI members attended the meeting. Highlights of the event include the release of the 2018 AMMI Annual Report as well as presentations from HRDF and MIDA. After the meeting, guests adjourned to the Smokehouse for CEO Networking.

13 June

5 September

AMMI Q3 Meeting, Jen Hotel Puteri Harbour Johor BahruThirty members attended meeting. Prior to the meeting, members also joined the members’ visit to Biocon Sdn Bhd, Asia’s largest integrated insulins manufacturing facility at the Biotech Park in Johor.

AMMI AGM and Q2 Meeting, E&O Hotel PenangFitfty-five members attended the AMMI 30th Annual General Meeting and Q2 Meeting. The AMMI Executive Board was announced during the meeting, with the following line-up: Chairman – Mr Christophe Marque (Stereo), Vice-Chairman, Mr John Ward (Steripack), Vice-Chairman, Mr Andy Lee (Johnson & Johnson), Secretary-General, Y.Bhg. Dato’ Dr. Hj. Haminnuddin Hj. Abd. Hamid (Ideal Healthcare) and Treasurer, Mr Michel Van Crombrugge (Paramit). The following member representatives were also elected to the AMMI Board of Directors: Dr Yuma Konishi (Texchem), Mr Samuel Pooranakaran (Cochlear), Mr Dave Mitchell (Boston Scientific) and Mr André Holzhausen (B.Braun Medical Industries).

During the Q2 meeting, Mr Jaspher Loo from the Northern Corridor Implementation Authority (NCIA) gave a presentation on the New NCER Tax Incentives and NCER Talent Enhancement Programme (NTEP). Guests adjourned for CEO Networking and Cocktails after the meeting.

AMMI Meetings & Networking

AMMI ANNUAL REPORT 201928 MEMBERSHIP

ACTIVITIES

One hundred and twenty members and invited guests attended the AMMI 30th Anniversary Dinner.Key Highlights from the event• Launch of the AMMI Medical Device Industry

Status and Outlook Report 2019/2020• Patient – Sharing on Impact of Medical

Technology• AMMI 30th Anniversary Appreciation Awards

5 December

AMMI Q4 Updates, 30th Anniversary Dinner and Launch of the AMMI Medical Device Industry Status Outlook Report 2019/2020, E&O Hotel, Penang


Left to right:Mr André Holzhausen, Mr Michel Van Crombrugge, Mr Andy Lee, Y.Bhg. Dato’ Dr. Hj. Haminnuddin Hj. Abd. Hamid, Mr Christophe Marque, Encik Mohamad Ismail Abu Bakar, Mr John Ward, Mr Samuel Pooranakaran, Mr Dave Mitchell, Dr Yuma Konishi and Mr Ching Choon Siong.

Three very special guests (bottom, left to right) Mr Sundar Selvaraj, Ms Natalie Dong and Ms Muna Raihannah shared their journey on how medical technology has made a difference in their lives

Launch of the AMMI Medical Device Industry Status and Outlook Report 2019/2020

Patient Sharing on the Impact of Medical Technology

MEMBERSHIPACTIVITIES


AMMI 30th Anniversary Appreciation Awards

Mr Christophe Marque also presented the awards for AMMI Founding Members, Top Participation in AMMI Public Training and Contribution in Global Expert Sharing


Founding Members Appreciation Award Left to right: Mr Ching Choon Siong, Mr Khor Siek Meng (Ansell), Mr Yuri (Bard – now known as BD), Mr Christophe Marque, Mr André Holzhausen (B. Braun) and Mr George Kazzi (Baxter)

Top Participation in AMMI Public Training – B.Braun Medical IndustriesLeft to right: Mr Hitendra Joshi, Mr Ching Choon Siong, Mr Christophe Marque, Mr André Holzhausen, Mr Ben Ong and Ms Quek Lang Fah

Top Participation in AMMI Public Training – AbbottLeft to right: Mr Ching Choon Siong, Mr Christophe Marque, Mr Eow Hu Teik and Ms Choong Lai Wan

Contribution in Global Expert SharingLeft to right: Mr Ching Choon Siong with Mr Scott Jackson (Amcor), Mr Eng Boon See (DuPont), Mr Christophe Marque, Mr Lai Kam Kuan (STERIS) and Mr André Holzhausen (B. Braun)

Top Participation in AMMI Public Training – Texchem Group. Left to right: Mr Jeffrey Wu, Mr Ching Choon Siong, Mr Christophe Marque, Dr Yuma Konishi and Mr Masaaki Ishida


Membership Engagement


14 June

PENTAX Medical hosted the visit of AMMI Board of Directors, Bayan Lepas, Penang

18 June

The Official Opening Ceremony of Cochlear’s Manufacturing Facility in Malaysia, Kuala Lumpur

2 May

21 May

AMMI embarked on “live-surveys” hosted by Board Members, with the objective of finding out more about members’ needs. Here are some of the events captured.

Hosted by Mr Michel Van Crombrugge, Treasurer | Venue: Paramit, Penang

Company Name PositionAllen Healthcare Mr Michael H’ng

Ms Lau Chiew KhimManaging DirectorChemist

Engineered Medical Systems Mr Mohamad Noor Managing DirectorKLS Martin Dato’ Hans Brenner

Ms Jess TewManaging DirectorFinance Manager

Hosted by Mr Eow Hu Teik, Secretary-General | Venue: Equatorial Hotel, Penang

Company Name PositionCCB Medical Devices Mr Stanley Goh PA to MDInteger Mr Tan Chin Soon

Mr Ravindran ShanmugamDirector of OperationsSenior QA Manager

Mira MEDsouce Mr Choo Beng Boon QA Manager


1. Gem Impression Sdn Bhd is a total solution provider for Medical and Eye care manufacturer. We specialize in helping customers from IDEAS to EXECUTION. We provide high quality cost effective Cleanroom Injection Moulding and Contract Manufacturing Services. Other services include Assembly Auomation & Robotics, and Innovations & Prototype Developments.

2. Kobayashi Healthcare (Malaysia) Sdn Bhd was established in October 2011. As a subsidiary of Kobayashi Pharmaceutical Company Limited, the indispensable role of Kobayashi Healthcare (Malaysia) Sdn Bhd is to exploit market in Malaysia. We are engaged in the marketing and selling of products of Kobayashi Pharmaceutical Group in Malaysia market by continuously launching new products to expand market share.

3. Polyplas Sdn Bhd was established in 1988 in Penang, Malaysia. Polyplas provides a complete range of processing techniques for the injection moulding of plastics. The Company offers design and fabrication of precision plastic injection tools, injection moulding of precision plastic parts, secondary processes for plastic parts, and assembly of semi-finished or completely finished products. Our facility includes a control room and an ISO Class 8 clean room equipped with high end electric machines catered for precise consistent manufacturing demanded by medical products. We currently produce equipment and single use devices for fields such as diagnostics, anaesthesia and respiratory care. In addition to thermoplastic injection moulding we also offer Liquid Silicone Rubber (LSR) parts to cater to the increasing demand from the medical industry.

4. Straits Orthopaedics is a private limited company that was established in 2003 for the sole purpose of providing contract manufacturing services in orthopaedics for legal manufacturers, and continues to be so today. Since 2003, Straits as a contract manufacturer has supplied orthopaedics devices to legal manufacturers with a total cost of goods value of about USD 160 million.

Upgraded to Full Members Membership Withdrawals

NEWMEMBERS


FULL MEMBERS DETAILS

1. St. Jude Medical Operations (Malaysia) Sdn. Bhd.St Jude Medical is now AbbottPlot 102, Lebuhraya Kampung Jawa, 11900 Bayan Lepas Industrial Zone, Penang, Malaysia.Tel: 04-810 1000 Fax: 04-810 1001Country of Origin: USA Website: www.sjmglobal.com

2. Ain Medicare Sdn BhdJalan 6/44, Kawasan Perindustrian Pengkalan Chepa 2, Kota Bharu 16100, Kelantan, Malaysia.Tel: 09-774 3388 Fax: 09-774 2205Country of Origin: Malaysia Website: www.ainmedicare.com.my

3. Allen Healthcare Products (M) Sdn Bhd17, Lorong Nagasari 2, Taman Nagasari, 13600, Perai, Penang, Malaysia.Tel: 604-390 1168 Fax: 604-383 1334Country of Origin: Malaysia Website: www.ahpmy.com

4. Ambu Sdn BhdLot 69B , Lintang Bayan Lepas 6, Phase IV, 11900 Penang, Malaysia.Tel: 604-252 9000 Fax: 604-644 8932Country of Origin: Denmark Website: www.ambu.com

5. Amcor Flexibles Asia PacificLot 823, Jalan Subang 5, Taman Perindustrian Subang USJ 1, 47600 Subang Jaya, Selangor, Malaysia.Tel : 603-8021 0998 Fax : 603-8021 0000 Country of Origin: UK Website: www.bemis.com

6. Ansell Global Trading Center (Malaysia) Sdn. Bhd.Prima 6, Prima Avenue, Block 3512, Jalan Teknokrat 6, 63000 Cyberjaya, Malaysia.Tel: 603-8310 6688 Fax: 603-8318 6699Country of Origin: Australia Website: www.ansell.com

7. APS Medical Sdn BhdNo. 28-32, Jalan Teluk Batu 36/2, Batu 4 ½, Jalan Kebun, Seksyen 36, 40470 Shah Alam, Selangor, Malaysia.Tel: 603-5162 2618 Fax: 603-5162 2619Country of Origin: Australia Website: www.apsmedical.com.au

8. Bard Sdn BhdLot 57C, Lorong Perusahaan 5, Kulim Industrial Estate, 09000 Kulim, Kedah, Malaysia.Tel : 604-480 1300 Fax : 604–489 1737 Country of Origin: USA Website: www.crbard.com

9. B. Braun Medical Industries Sdn BhdBayan Lepas Free Industrial Zone, P O Box 880, 10810 Penang, Malaysia.Tel : 604-632 3100 Fax : 604-643 3750 Country of Origin: Germany Website: www.bbraunap.com

10. Boston Scientific Medical Device (Malaysia) Sdn BhdPMT 741, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan14100, Bandar Cassia, Penang, Malaysia.Tel: 604-555 6688 Fax: 604-555 6699Country of Origin: USA Website: www.bostonscientific.com

11. Cochlear Malaysia Sdn BhdUnit UG1, Upper Ground Floor, Vertical Podium, Avenue 3, Bangsar South, No.8, Jalan Kerinchi,59200 Kuala Lumpur, Malaysia.Tel: 603-2282 3839 Fax: 603-2282 3839 Country of Origin: Australia Website: www.cochlear.com

12. Diptech Industries Sdn BhdNo.11 Jalan Angsana 1/3, Taman Perindustrian Angsana, 08000 Sungai Petani, Kedah, Malaysia.Tel: 604-422 3688 Fax: 604-424 0941Country of Origin: Malaysia Website: www.diptech.com.my

AMMI MEMBERS'DIRECTORY



13. DuPont Malaysia Sdn BhdLevel 7, Menara CIMB, Jalan Stesen Sentral 2, Kuala Lumpur Sentral, 50490 Kuala Lumpur, Malaysia.Tel: 603-2859 0700 Fax: 603-2859 9079Country of Origin: USA Website: www.dupont.com

14. Engineered Medical Systems Malaysia Sdn Bhd993, Lorong Perindustrian Bukit Minyak 11, Taman Perindustrian Bukit Minyak, 14100, Simpang Ampat, Penang, MalaysiaTel: 604-504 1252 Fax: 604-504 1253Country of Origin: Malaysia Website: www.EngMedSys.com

15. Epsilon Medical Devices Sdn BhdLot 5271, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting, Perak, Malaysia.Tel: 605-891 3158 Fax: 605-891 1266Country of Origin: Malaysia Website: www.epsilon-group.com

16. Fresenius Medical Care Production Sdn BhdLot 34618, PT29466, Bandar Enstek, Mukim Labu, 71760 Bandar Enstek, Negeri Sembilan, Malaysia.Tel: 606-791 5334 Fax: 606-791 5336Country of Origin: Germany Website: www.fmc-my.com

17. Haemonetics Malaysia Sdn BhdPMT727, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan,14100 Simpang Ampat, Seberang Perai Selatan, Penang, Malaysia.Tel: 604-503 5141 Country of Origin: USA Website: www.haemonetics.com

18. Hospitech Manufacturing Services Sdn BhdSub Lot, 1 Lot 6536, Batu 6, Jalan Bukit Kemuning, 40460 Shah Alam, Selangor, Malaysia.Tel: 603-5122 5199 Fax: 603-5122 5204 Country of Origin: Malaysia Website: www.hospitech.net

19. Ideal Healthcare Sdn BhdLot PT 60598, Kawasan Perindustrian LPK Fasa 1, 08000 Sungai Petani Kedah, Malaysia.Tel: 604-444 6875 Fax: 604-444 5975 Country of Origin: Malaysia Website: www.idealcare.com.my

20. ITL Asia Pacific Sdn BhdPlot 17B, Lorong Bemban 2, Bemban Industrial Estate, 31000, Batu Gajah Perak, Malaysia.Tel: 605-362 9988 Fax: 605-362 9966 Country of Origin: Australia Website: www.itl-limited.com

21. Johnson & Johnson Sdn BhdLevel 8, The Pinnacle, Persiaran Lagoon, Bandar Sunway, 46150, Petaling Jaya, Selangor, Malaysia. Tel: 603-7661 4615 Fax: 603-7610 0519 Country of Origin: USA Website: www.jnj.com

22. KLS Martin Malaysia Sdn BhdNo. 1193, Lorong Perindustrian Bukit Minyak 11, Taman Perindustrian Bukit Minyak,14100 Simpang Ampat, Penang, Malaysia.Tel: 604-506 2380 Fax: 604-506 2303 Country of Origin: Germany Website: www.klsmartin.com

23. Integer (Lake Region Medical Sdn Bhd)No. 91-B, Lebuhraya Kampung Jawa, 11900 Bayan Lepas, Penang, Malaysia.Tel: 604 - 810 1800 Fax: 604-643 1232Country of Origin: USA Website: www.integer.net

24. Medipro Malaysia Sdn BhdLot 15, Lebuh Hishamuddin 3, Kawasan 20, Bandar Sultan Sulaiman, 42000 Port Klang, Selangor, Malaysia.Tel: 603-3176 3446 Fax: 603-3176 4229 Country of Origin: Japan Website: www.medipro.com.my

AMMI MEMBERS’DIRECTORY



25. Mediquip Sdn BhdPadang Lati, Mukim Paya, P.O. Box 25, 01700 Kangar, Perlis, Malaysia.Tel: 604-938 1411 ext: 222 Fax: 604-938 2150 Country of Origin: USA Website : www.cardinalhealth.com

26. Meditop Corporation (M) Sdn BhdLot 3, Persiaran Usahawan, Taman Iks, Seksyen 9, 43650 Bandar Baru Bangi, Selangor, Malaysia.Tel: 603-8925 8462 Fax: 603-8925 8468 Country of Origin: Japan Website: www.top-tokyo.co.jp

27. Molnlycke Health Care Sdn BhdLot 9 Lorong Perusahaan 4, Kulim Industrial Estate, 09000 Kulim, Kedah, Malaysia.Tel: 604-489 1819 Fax: 604-489 1220 Country of Origin: Sweden Website: www.molnlycke.com

28. Muzamal Industries Sdn BhdLot 21, Jalan 3A, Kawasan Perindustrian Cheras Jaya, 43200 Cheras, Selangor, Malaysia.Tel: 603-9076 3080 Fax: 603-9080 3098Country of Origin: Malaysia Website: www.muzamal.com

29. Nitritex (M) Sdn Bhd2 Jalan Jurunilai U1/20, Seksyen U1, Hicom Glenmarie Industrial Park, 40150 Shah Alam, Selangor, Malaysia.Tel: 603-5569 3857 / 3859 Fax: 603-5569 3862 Country of Origin: UK Website: www.bioclean.com

30. Orthomedic Innovations Sdn Bhd188-D, Jalan Sultan Azlan Shah, Sungai Tiram, 11900 Bayan Lepas, Penang, Malaysia.Tel: 604-644 5139 Fax: 604-6449139Country of Origin: Malaysia Website: www.orthomedic.com.my

31. Owen Mumford Sdn BhdNo. 21, Jalan Bioteknologi 3, Kawasan Perindustrian SiLC, Nusajaya, 79200 Johor, Malaysia.Tel: 607-553 9617 Fax: 607-553 9617Country of Origin: UK Website: www.owenmumford.com/en

32. Paramit Malaysia Sdn BhdPMT 1199, Penang Science Park, Lorong Perindustrian Bukit Minyak 21,14100 Simpang Ampat, Seberang Perai Tengah, Penang, Malaysia.Tel: 604-540 7000 Fax: 604-540 7111 Country of Origin: USA Website: www.paramit.com

33. Prent Malaysia Sdn BhdPTD102587, Jalan Cyber 14, Senai Industrial Park IV, 81400 Senai, Johor, Malaysia.Tel: 607-599 7661 Fax: 607-599 7660 Country of Origin: USA Website: www.prent.com.my

34. Sanmina-SCI Systems (Malaysia) Sdn BhdPlot 202, Lorong Perusahaan Maju 9, Bukit Tengah Industrial Estate, 13600 Perai, Penang, Malaysia.Tel: 604-508 1228 Fax: 604-508 1233 Country of Origin: USA Website: www.sanmina.com

35. Sin Yong Guan Industries Sdn. Bhd.8 Solok Rishah 2, Kawasan Perindustrian Silibin, 30100 Ipoh, Perak, Malaysia.Tel: 605-526 7231 Fax: 605-526 8491 Country of Origin: Malaysia Website: www.syg53.com

36. Star Medik Sdn BhdNo.43. Jalan Tiara Sentral 2, Nilai Utama Enterprise Park, 71800, Nilai, Negeri Sembilan, Malaysia.Tel: 603-8706 5282/2934 Fax: 603-8706 5805 Country of Origin: Malaysia Website: www.starmedik.com.my




37. Stereo Sdn Bhd37, Lorong Sungai Puloh 1A/KU6, Taman Teknology Gemilang, Kawasan Perindustrian Sungai Puloh,41050 Klang Selangor, Malaysia.Tel: 603-3290 2263 Fax: 603-3290 2016 Country of Origin: Malaysia Website: www.stereocorp.com

38. SteriPack Contract ManufacturingPT119992, Jalan Canang Emas 8, Telok Gong, 42000 Klang, Selangor, Malaysia.Tel: 03-3167 3596 Fax: 03-3167 3597Country of Origin: Ireland Website: www.steripackgroup.com

39. Symmetry Medical Malaysia Sdn Bhd (Tecomet)Plot 80C, Kawasan Perindustrian Bayan Lepas, Phase 4, Lintang Bayan Lepas 7, 11900 Penang, Malaysia. Tel: 604-645 6802 Fax: 604-644 5805Country of Origin: USA Website: www.tecomet.com

40. Synergy Sterilisation (M) Sdn Bhd (now part of STERIS)Plot 203 Kuala Ketil Industrial Estate, 09300 Kuala Ketil, Kedah, Malaysia.Tel: 604-415 2111 Fax: 604-415 2121 Country of Origin: U.S. Website: www.steris-ast.com

41. Teleflex Medical Sdn BhdLot No. PT2577, Jalan Perusahaan 4, 34600 Kamunting, Perak, Malaysia.Tel: 605-891 5111 Fax: 605-891 2699 Country of Origin: USA Website: www.teleflexmedical.com

42. Texchem Life Sciences Sdn BhdLot 3, Jalan P/6, Kawasan Perindustrian Bangi, No. 2, Bandar Baru Bangi, 43650, Selangor, Malaysia.Tel: 603-8925 0370 Fax: 603-8925 0317 Country of Origin: Japan Website: www.texchem-pack.com

43. Tomoe Malaysia Sdn BhdLot 13, Jalan Kulim Hi-Tech 13 Kulim Hi Tech Park Phase 3 Kulim, Kedah 09000 Malaysia.Tel: 604-492 4101 Fax: 604-492 4202 Country of Origin: Japan Website: www.tomoeshokai.co.jp

44. Top Glove Sdn BhdLot 4968, Bt 6 Jalan Teratai, Off Jalan Meru, 41050 Klang, Selangor, Malaysia.Tel: 603-3392 1992 / 1905 Fax: 603-3392 1291 / 8410 Country of Origin: Malaysia Website: www.topglove.com

45. UWHM Sdn Bhd987, Jalan Perindustrian Bukit Minyak 7, Mukim 13, Kawasan Perindustrian Bukit Minyak,14000 Bukit Mertajam, Penang, Malaysia.Tel: 604-507 8086 Fax: 604-507 9298 Country of Origin: Malaysia Website: www.uwcholdings.com

46. Vigilenz Medical Devices Sdn BhdNo. 308 B, Jalan Perindustrian Bukit Minyak 18, Penang Science Park, 14100 Penang, Malaysia.Tel: 604- 5054 241/9841 Fax: 604- 5059 367 Country of Origin: Malaysia Website: www.vigilenzmd.com

47. Worldwide Medivest Sdn BhdNo. 2, Jalan Karyawan 4/KU7, Lorong Sg Puloh, Taman Kapar Bestari, Kapar 42200, Selangor, Malaysia.Tel: 03-3291 2625 Fax: 03-3291 2725 Country of Origin: Malaysia Website: www.wmsb.com.my

48. Zeito Plastics Components Sdn BhdLot 19-6, Bersatu Industrial Complex, Jalan CJ1/1, Cheras Jaya,43200 Cheras, Selangor Darul Ehsan, Malaysia.Tel: 03-9074 9177 Fax: 03-9074 9096 Country of Origin: Malaysia Website: www.zeito.com.my



ASSOCIATE MEMBERS DETAILS

1. 3M Malaysia Sdn BhdLevel 8, Block F, Oasis Square, No.2, Jalan PJU1A/7A, Ara Damansara,47301 Petaling Jaya, Selangor, Malaysia.Tel: 603-7884 2888 Fax: 603-7884 2902Country of Origin: USA Website: www.3M.com

2. Alcon Laboratories (M) Sdn BhdLevel 20-1, Tower B, Plaza 33, No.1, Jalan Kemajuan, Seksyen 13, Petaling Jaya Selangor 46200, Malaysia.Tel: 603-79481888 Fax 603-79481888Country of Origin: USA Website: www.alcon.com

3. Baxter Healthcare Sdn BhdB-21-3A, Level 21, The Ascent, Paradigm, No.1, Jalan SS7/26A, Kelana Jaya, 47301 Petaling Jaya, Selangor, Malaysia. Tel: 603-7611 6899 Fax: 603-7611 6800Country of Origin: USA Website: www.baxter.com.my

4. Becton Dickinson Sdn BhdUnit 24, LG 5 (Executive Wing), Hotel Equatorial Penang, 1 Jalan Bukit Jambul,11900 Bayan Lepas, Penang, Malaysia.Tel: 604-640 5688 Fax: 604-640 5686 Country of Origin: USA Website: www.bd.com/my/

5. BillerudKorsnas Aktiebolag10th Floor, Menara Hap Seng, No. 1 & 3 Jalan P. Ramlee, 50250 Kuala Lumpur, Malaysia.Tel: 603-7806 1219 Fax: 603-7806 1219 Country of Origin: Sweden Website: www.billerudkorsnas.com

6. Biocon Sdn BhdNo.1 Jalan Bioteknologi 1, Kawasan Perindustrian SILC, 15 Bandar Puteri Johor, 79200, Johor, Malaysia.Tel: 607-560 0000 Fax: 607- 560 0050 Country of Origin: India Website: www.biocon.com

7. CCB Medical Devices Sdn BhdPMT 1124, Jalan Perindustrian, Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat, Penang, 14100 Malaysia.Tel: 604-504 0198 Fax: 604-504 0908 Country of Origin: Germany Website: www.ccb-medical.com

8. Gem Impression Sdn Bhd 9&11, Lorong Serunai 2, 14200 Sungai Bakap Penang, Malaysia.Tel: 604-583 3688 Fax: 604-583 3689 Country of Origin: Malaysia Website: www.gem-i.net

9. KOBAYASHI Healthcare (Malaysia) Sdn. Bhd. 50-2-2A, Level 2, Wisma UOA Damansara, 50, Jalan Dungun, Damansara Heights, 50490 Kuala Lumpur, Malaysia. Tel: 603-2011 7702 Fax: 603-2011 7701 Country of Origin: Japan Website: https://kobayashi-my.com/

10. Medtronic Malaysia Sdn BhdB-23-1, The Ascent, Paradigm, No 1 Jalan SS7/26A, Kelana Jaya, 47301, Petaling Jaya, Selangor, Malaysia.Tel: 603-7883 8000 Fax: 603-7886 0474 / 4702Country of Origin: Ireland Website: www.medtronic.com

11. MIRA Medsource (Malaysia) Sdn Bhd35, 1st Floor, Jalan Todak 6, Pusat Bandar Sunway Perdana, 13700 Seberang Jaya, Penang, Malaysia.Tel: 604-383 8025 Fax: 604-383 1845 Country of Origin: China Website: www.miramedsource.com

12. Multivac Sdn BhdLot 10-E, Pusat Teknologi Sunsuria, Jalan Teknologi, Taman Sains Selangor,Kota Damansara 47810 Petaling Jaya, Selangor, Malaysia.Tel: 603-6151 9885 Fax: 603-6143 6885 Country of Origin: Germany Website: www.multivac.com

13. Nihon Kohden Malaysia Sdn.Bhd.Suite 15-13,Level 15, Gtower, 199 Jalan Tun Razak, Kuala Lumpur, 50400, Malaysia.Tel: 603-2161 0100 Fax: 603-2161 2520Country of Origin: Japan Website: www.nihonkohden.com.my



ASSOCIATE MEMBERS DETAILS

14. PENTAX Medical Sdn BhdPlot 12 & 13, Fasa 4 Hilir Sungai Keluang 3, 11900 Bayan Lepas Penang, Malaysia. Tel: 604-637 9800 Country of Origin: Japan Website: https://www.pentaxmedical.com/

15. Plastic STC Sdn BhdNo 7 Jalan TSB 9, Taman Industri Sg Buloh, 47000 Sungai Buloh, Selangor, Malaysia.Tel : 603-6157 5313 Fax : 603-6157 5318 Country of Origin: Malaysia Website: www.hlhightech.com

16. PMA Manufacturing Sdn BhdNo. 11, Lintang Beringin 2, Diamond Valley, 11960 Georgetown, Penang, Malaysia.Tel: 604-626 1518 Fax: 604-626 5253 Country of Origin: Malaysia Website: www.pmaasia.com

17. Polyplas Sdn BhdNo 2056, Mukim 14, Lorong IKS Bukit Minyak 5, Taman IKS Bukit Minyak, Bukit Mertajam, Pulau Pinang, 14000, Malaysia. Tel: 604-507 0188, 507 6479, 5076480 Fax: 604-507 8188 Country of Origin: Malaysia Website: www.polyplassb.com

18. Prodelcon Sdn Bhd78 Lintang Bayan Lepas 7, Phase 4, Hilir Sungai Keluang 3, Bayan Lepas, 11900 Penang, Malaysia.Tel: 604-643 8913 Fax: 604-643 8914 Country of Origin: Malaysia Website: www.psb.com.my

19. Professional Tools & Dies Sdn Bhd7118,Jalan Mak Mandin, Kawasan Perindustrian Mak Mandin, 13400 Butterworth, Penang, Malaysia.Tel: 604-332 2335 Fax: 604-331 2337 Country of Origin: Malaysia Website: www.professional-tools.com

20. Ried Q&C Consulting Sdn Bhd18, Lorong Lembah Permai 4, 11200 Tanjung Bungah, Penang, Malaysia.Tel: 6012-561 7005 Fax: 604-899 9105 Country of Origin: Malaysia Website: www.ried-qcc.de

21. Smith & Nephew Healthcare Sdn BhdSuite 11.01B & 11.02, Level 11, Menara AmFirst, No. 1 Jalan 19/3, 46300 Petaling Jaya, Selangor, Malaysia. Tel: 03-7958 7103 Fax: 03-7958 6813Country of Origin: United kingdom Website: www.smith-nephew.com

22. Sontara South Asia Sdn BhdLevel 15-1, 1 First Avenue, 2A, Dataran Bandar Utama Damansara, 47800 Petaling Jaya, Selangor, Malaysia.Tel: 603-7651 7396 Fax: 603-7651 7701Country of Origin: Denmark Website: www.jacob-holm.com

23. Straits Orthopaedics (Mfg) Sdn Bhd2483, Tingkat Perusahaan 4A Prai Free Industrial Zone, 13600 Prai Penang, Malaysia. Tel: 604-3831885 Fax: 604-3838178 Country of Origin: Malaysia Website:www.straitsortho.com

24. Tako Astatic Technology Sdn Bhd15 Jalan Kesuma 2/2, Bandar Tasik Kesuma, Beranang, 43700 Selangor, Malaysia.Tel: 603-8723 8843 Fax: 603-8723 8844 Country of Origin: Malaysia Website: www.tako.com.my

25. Terumo Malaysia Sdn BhdSuite C405, 4th Floor, Center Tower, Wisma Consplant 1, No. 2, Jalan SS16/4,47500 Subang Jaya, Selangor, Malaysia.Tel: 603-5880 8898 Fax: 603-5880 8891 Country of Origin: Japan Website: www.terumo.com

26. Varian Medical Systems (M) Sdn BhdSuite B-15-5, Wisma Pantai, Plaza Pantai, No. 5, Jalan 4/83A,Off Jalan Pantai Baru 59200, Kuala Lumpur, Malaysia.Tel: 603-2296 7600 Fax: 603-2296 7601 Country of Origin: Malaysia Website: www.varian.com


Association of Malaysian Medical Industries (AMMI)c/o Medsociate Sdn BhdLevel 32 Menara Prestige,No. 1 Jalan Pinang,50450 Kuala Lumpur, Malaysia.Tel : +6010 4040 662Fax : +603 2178 4347Email : [email protected]

(R.O.S. Registration No. PPM-025-07-19031992

Registered Officec/o Fastrack Corporate Sdn Bhd51-13-A Menara BHL Bank,Jalan Sultan Ahmad Shah,10050 Penang.

www.ammi.com.my

AMMI Secretariat and Training Programmes are managed by

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