Medical device registration in emerging markets

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Medical device registration in emerging markets

Fast Access Markets: Singapore, Hong Kong and Other Emerging

Markets to Consider



Fast Access Markets: Singapore Hong Kong Malaysia

Israel Colombia Costa Rica



Medical Device Registration in Singapore Why export to the Singaporean medical device market?

• Population of 5 million • GDP of $314 billion, 40th largest global economy* • Singapore’s medical device market totals $535 million** • Influencer on other Southeast Asian markets • Exclusive importer of medical devices

*2011 CIA World Factbook figures ** Singapore Economic Development Board



Singapore Medical Device Market Overview

• The Singapore government published the Health Products (Medical Device) Regs 2010 on August 10, 2010.

• These regulations provided for the registration of medical, importers and wholesalers as administered by the Health Sciences Authority (HSA).

• A Registrant submits application and supporting documents through Medical Device Information and Communication System (MEDICS).

• Once the HSA issues a “registerable” decision, the device can be listed in Singapore Medical Device Register (SMDR) and commercialization can begin.



Singapore Medical Device Market Overview, cont’d.

• With reference agency approval (one of the GTHF members) devices can be submitted through the abridged evaluation route.

• All Class A non-sterile devices are now exempt from the regulatory review process.

• Class B devices that have registration in two reference markets (e.g., US, Europe, Australia, Canada or Japan) and are marketed for three years without safety concerns qualify for an Immediate Registration route.

• Class B devices that have approval in two reference markets, or one reference market and at least three years in that market without safety concerns qualify for an Expedited Registration route.



Device Classification in Singapore

Singapore’s regulatory system is based on GHTF recommendations and is closely aligned with other GHTF-

based systems.

Increasing risk to patient or user

Class A Class B Class CC Class DC



Singapore Registrant Requirements • Foreign manufacturers with no local presence in Singapore must appoint a

Singapore Registrant to deal with the HSA on their behalf. • Your Registrant must be an individual legally residing in Singapore, or an entity

holding a proper business registration in Singapore.



Singapore Registrant, cont’d.

•Serves as communication channel •Manages complaint handling

•Manages your application for listing •Upholds maintenance/service arrangements

•Maintains duplication records •Tracks product alerts, modifications and recalls

•Tracks specific devices •Manages reportable adverse events and reporting changes

Registrant Responsibilities



Prepare and Submit Application (e.g., Abridged Submission )

• List of authorized importers and wholesalers • Declaration of Conformity signed and scanned • Letter of authorization signed and scanned • Essential Principles • Approval status and date in each reference country • Copies of certificates or approval letters from reference countries • Summary of AEs and FSCA for all reference countries since market entry • HS Code(s) • List of Configurations; i.e., models of family, components of system, etc. ) • Tech File in ASEAN Common Submission Dossier Template (CSDT) format

Required for a medical device registration submission for Classes B, C, & D with prior

authorization in a GHTF-founding member country.



Regulatory Roadmap: Singapore

1) Appoint your Singapore Registrant

2) Compile necessary application documents

3) Singapore registrant submits your application through MEDICS

4) HSA either rejects your application or deems your device “registrable”

5) Register your device in the Singapore Medical Device Register

6) Begin marketing your device in Singapore

7) Meet post-market requirements



HSA Registration Fees and Timelines

• All HSA fees quoted in Singapore dollars (SGD).

Device class Application Fee*

Abridged Evaluation Fee*

Abridged Evaluation Timeline

Full Evaluation Fee*

Full Evaluation Timeline

Annual fee*

Class A (S/M)

$25 n/a n/a n/a n/a $25

Class B Immediate $500 $1,400 n/a n/a n/a $25 Class B Expedited $500 $1,400 60 days n/a n/a $25

Class B $500 $1,800 100 days $3,500 160 days $35 Class C $500 $3,500 160 days $5,700 220 days $60 Class D $500 $5,700 220 days $11,400 310 days $120 Combination $500 $10,000 310 days $75,000



Medical Device Registration in Hong Kong • Population of 7 million • GDP of $350 billion* • Per capita income of $32,000, 8th highest globally • Hong Kong’s medical device market totals $245 million** • Influencer on large Chinese market • Exclusive importer of medical devices

*2011 CIA World Factbook figures **U.S. Department of Commerce’s International Trade Administration



Hong Kong Medical Device Market Overview • The Government of Hong Kong , Department of Health

launched the Medical Device Administrative Control System (MDACS) on 26 November26, 2004. Currently there is a voluntary listing program for Class IV (High Risk) Medical Devices as well as Class II and Class III (Medium Risk) Medical Devices, and Class D IVD Medical Devices.

• Compliance is obtained in Hong Kong by demonstrating that your device conforms to the requirements of the MDACS. When conformance has been demonstrated, the Medical Device Control Office (MDCO) will issue a listing number and add the device to the List of Medical Devices.



Device Classification in Hong Kong

Class I Class II Class III Class IV


Hong Kong’s regulatory system is based on GHTF recommendations and is closely aligned with other GHTF-

based systems.



Hong Kong Representation: Local Responsible Person

• Foreign manufacturers with no local presence in Hong Kong must appoint a Local Responsible Person to liaise with Hong Kong regulators.

• Your Local Responsible Person must be a legal resident of or have a valid business registration

in Hong Kong.



Hong Kong Local Responsible Person, cont’d.

Local Responsible Person Responsibilities:

•Serves as communication channel •Manages complaint handling

•Manages your application for listing •Upholds maintenance/service arrangements

•Maintains duplication records •Tracks product alerts, modifications and recalls

•Tracks specific devices •Manages reportable adverse events and reporting changes



Hong Kong Device Reviews • It is estimated to take three to six weeks from receipt of required

documentation to complete application preparation.

• Time for vetting and approval by MDCO is estimated to take 12 weeks if all supporting documentation is properly included.

• Listings are valid for five years.

• Voluntary listings are expected to be valid when the system becomes mandatory, but transition fees may be applied.

• Please note a Local Responsible Person (LRP) must perform the application submission for a medical device listing. The LRP also has post-market responsibilities that include adverse incident reporting, complaint handling, and recalls.



Hong Kong Post-market Vigilance Hong Kong authorities require special tracking requirements for the following devices:

•Mechanical heart valves

•Implantable pacemakers, electrodes and leads

•Implantable defibrillators, electrodes and leads

•Implantable ventricular support systems

•Implantable drug infusion systems



Post-market Vigilance, cont’d.

• Devices with special post-market surveillance requirements must be tracked down to the user-facility level so that these facilities can assist potential recall efforts.

• The following information must be tracked for devices with these requirements: – Date the device went into service or

implanted into a patient in Hong Kong – Date the device was permanently retired

from use or removed from a patient



Hong Kong Medical Device Market Considerations

• Listing your device in Hong Kong is currently voluntary, but listing is required in order to participate in public hospital tenders.

• Listing your device now can help avoid the rush when Hong Kong’s mandatory registration system goes into effect in the near future.



Medical Device Regulation in Malaysia

• Population of 29 million • GDP: $447 billion* • Per Capital: $15,600 (77th globally)* • 29th largest importer globally*

*2011 CIA World Factbook figures



Malaysian Medical Device Regulatory Overview

• Medical device registration in Malaysia is overseen by the Medical Device Control Division (MDCD) under the Ministry of Health.

• Registration in Malaysia is done through the Voluntary Registration of Medical Device Establishments (MeDVR) online tool. A device registration application must include an Accounts Application Form (MeDVER-01) and an Establishment Registration Form (MeDVER-02).

• Registration is currently voluntary in Malaysia, but a new mandatory system is expected to be fully implemented in 2012 or 2013. Draft regulations are based on Global Harmonization Task Force (GHTF) principles.



Proposed Device Classification in Malaysia

Class A Class B Class C Class D


•Draft medical device regulations establish a four-tier classification system in Malaysia based on risk to patients/users.



Authorized Representation Requirements in Malaysia

• Foreign manufacturers with no local presence in Malaysia must name an authorized representative to manage their registration process.

• Your Malaysia authorized representative must be a citizen or permanent resident of the country.



Medical Device Registration in Israel • Population: 7 million • GDP: $235 billion* • GDP Per Capita: $31,000 (41st globally)* • 46th largest importer globally* • Major Middle Eastern market for medical

devices

*2011 CIA World Factbook figures



Israeli Medical Device Registration Overview • Medical device registration in Israel is overseen

by the Ministry of Health’s Department of Medical Devices (AMAR).

• The Israeli registration system is based largely on prior market authorization in the US or EU.

• Devices with US FDA registration, Notified Body-issued CE Marking, and/or Australian ARTG listing are typically approved by AMAR without additional requirements.



Medical Device Classification in Israel • AMAR does not use its own classification system for medical devices. • Device classifications in the US, EU, Australia and Japan are recognized and relied

upon by Israeli regulators.



Israel: Electrical Device Testing Requirements Most electrical medical devices must obtain certification from the Israeli Standard

Institute (ISI). If your device conforms to IEC 60065, IEC 60950 or IEC 60601, ISI certification will likely be necessary as part of your Israeli registration effort.

ISI registration is valid for one year.



Israel Registration Holder (IRH)

• In-country representation through an Israel Registration Holder is required by Israeli

regulators if you do not have a local presence in the country.

• Your IRH must be a legal resident of Israel, and serves as your liaison with AMAR.



Israel Registration: Fees and Timelines

Registration fee: 1,200 ISL plus VAT (≈ US $300)

ISI Certification fee: $900 - $1200

Registration timeline: ≈ 6 to 9 months from date of submission



Regulatory Roadmap: Israel

1) Appoint IRH 7) Registration Application Number and Registration Certificate issued

2) Prepare required registration documents and send to your IRH

8) Request and obtain yearly import permit from AMAR

3) IRH submits documents to AMAR 9) Maintain post-market obligations

4) AMAR reviews application

5) Obtain ISI certification if necessary

6) Import devices for ISI testing, if necessary



Medical Device Registration in Colombia

• Population: 45 million • GDP: $471 billion* • Per capita: $10,100 (109th globally) • 51st largest importer globally



Colombia Medical Device Market Overview

• Most medical devices must be registered with Colombia’s medical device market regulator, the National Food and Drug Surveillance Institute (INVIMA).

• Lower-risk devices receive automatic registration following submission of required documents.

• Lower-risk devices are designated as “Non-Controlled” devices, while higher-risk devices are designated as “Controlled” devices.



Device Classification in Colombia

Class I (Non-Controlled)

Class IIa (Non-Controlled)

Class IIb (Controlled)

Class III (Controlled)


•Class I and IIa devices (Non-Controlled devices) are eligible for automatic registration •Class IIb and III devices (Controlled devices) must go through INVIMA pre-registration reviews •Colombia’s classification system is modeled on EU device classification



Quality System Requirements in Colombia • Proof of compliance with international

quality standards via ISO 13485 certification is required as part of the Colombian registration process.



Colombia Legal Representative You must appoint legal representative to manage your registration process.

Your in-country representative must be a lawyer.



Regulatory Roadmap: Colombia 1) Appoint a Legal Representative and provide them Power of Attorny

2) Verify compliance of your documents with INVIMA requirements

3) Compile technical submission

4) Provide product certifications and testing methodologies

5) File registration application with INVIMA

6) Address any questions from reviewers

7) Make any legal or technical revisions necessary

8) Begin marketing your device in Colombia

9) Meet post-market obligations



Colombian Device Registration: Fees and Timelines

INVIMA registration fees range from $900 to $1,100 per application.

Class I and IIa: immediate registration

Class IIb and III: six to eight months depending on INVIMA backlog

INVIMA registrations are valid for 10 years.



Medical Device Registration in Costa Rica

Population: 4.6 million* GDP: $54 billion* Per capita: $11,500 (102nd globally)* Imports: $15 billion (82nd globally)*

*Source: CIA World Factbook figures



Costa Rican Medical Device Market Overview • Most medical devices must be registered with the Costa Rican Ministry of Health

prior to commercialization in the country. • Devices with FDA clearance/approval are “fast-tracked” to approval.



Device Classification in Costa Rica

Class I Class II Class III Class V


Medical device classification in Costa Rica differs from GHTF guidelines.



Costa Rica In-country Representation If you have no local business presence in Costa Rica, you must appoint an in-country

representative to manage your registration process. Your in-country representative must be authorized by the Ministry of Health to act in

that capacity.



Regulatory Roadmap: Costa Rica

1) Appoint your in-country representative

2) Compile all necessary application documents

3) Submit your application dossier to the Ministry of Health

4) Address any questions from reviewers

5) Receive Ministry approval and registration number

6) Market your device in Costa Rica

7) Meet post-market requirements



Costa Rican Medical Device Registration: Fees and Timelines

• Official registration fees in Costa Rica are $10 for Class 1 device reviews; $25 for Class 2 device reviews, and $50 for Class 3 and 4 device reviews.

• There are two phases to device reviews: Legal and Technical. Timeframes for device reviews are 45 days for Class 1 and 2 devices, and 60 days for Class 3 and 4

devices. (Actual review times can vary according to device complexity and quality of your registration application.)



Additional Resources Singapore registration: http://www.emergogroup.com/services/singapore/singapore-registration Singapore authorized representation: http://www.emergogroup.com/services/singapore/singapore-authorized-rep Hong Kong registration: http://www.emergogroup.com/services/hongkong/hong-kong-device-registration Malaysia regulations: http://www.emergogroup.com/resources/regulations-malaysia Malaysia registration: http://www.emergogroup.com/services/malaysia/malaysia-registration Israel registration: http://www.emergogroup.com/services/israel/medical-device-registration-israel Israel authorized representation: http://www.emergogroup.com/services/israel/israel-registration-holder Colombia regulations: http://www.emergogroup.com/resources/regulations-colombia Colombia registration: http://www.emergogroup.com/services/colombia/colombia-medical-device-registration Costa Rica registration: http://www.emergogroup.com/services/costarica/costa-rica-registration

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Thank you for your time.

Bryan Gilburg Vice President of Business Development

[email protected] +1.512.600.7626

Ann Marie Boullie Director of Business Development

[email protected] +1.512.600.7605

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mailto:[email protected]�

Date post:	22-Nov-2014
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Medical device registration in emerging markets

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