Date: 5th March 2020Venue: Tropicana Golf and Country Resort

COLLABORATION ON CERTIFICATION FOR MEDICAL DEVICES INTEGRATED WITH COMMUNICATION CAPABILITY

1. OBJECTIVES

Enhance awareness and increase control over the certification and importation of communication, multimedia and hybrid products

in the medical sector

Protect the spectrum from frequency interference and

preserve the quality of telecommunications service.

Protect consumers from unsafe, faulty, substandard or

counterfeit/cloned products through certification.

To share on the Check Your Label (CYL) campaign in creating public

awareness on certified communication devices.

To response on inquiries and provide clarifications on the regulatory and certification

requirements.

OBJECTIVES

2. INTRODUCTION

ACTS & REGULATIONS

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LABELING

Rules:

P.U.(A) 124 CMA 1998

TSR 2000 Regulation 22.

IMPORT PERMIT REQUIREMENTS

Manner of Import for Products with tariff code assigned to SIRIM:“That the import is accompanied by a Certificate of Approval issued by SIRIM. The import shall be certified to the Malaysian Standards or Technical Codes or Technical Declaration which are deemed fit to the import and in accordance with the Communications and Multimedia Act 1998, its subsidiary legislations, statutory requirements and established rules and procedures”.

Rules:

Customs (Prohibition Of Import) Order 2017

COMPLIANCE APPROVAL

Rules:

Communications and Multimedia

(Technical Standards) Regulations

2000

P.U.(A) 124 CMA 1998 TSR 2000)Regulation 14 - 22.

ACTS & REGULATIONS

LEGISLATIONS PROVISIONS PENALTY

Communication and Multimedia Act

1998

Hindering interoperability an offence [Section.182] RM500K / 5 years / both

Compromising public safety an offence [Section.183] RM500K / 5 years / both

Emission from non-standard equipment or device [Section.238] RM50K / 1 year / both

Unlawful use, possession or supply of non-standard equipment or device [Section.239] RM100K / 2 years / both

Communications & Multimedia (Technical Standards)

Regulations 2000

All communications equipment which are required to be certified under these Regulations shall be so certified. [Regulation.14]

RM100K / 6 months / both

No person shall intentionally design, install, operate, maintain or modify any communications equipment in a manner which is contrary to the standards [Regulation.15]

RM300K / 3 years / both

No person shall use, offer for sale, sell or have in his possession with a view to sell any communications equipment which is contrary to the standards [Regulation.16]

RM100K / 6 months / both

All certified communications equipment bears a certification mark or label approved by the Commission or a registered certifying agency, as the case may be, so as to indicate that it complies with the standards [Regulation. 22(a)]

RM100K / 6 months / both

Class Assignments 1/2019

Class assignment shall ensure that only devices certified by the Commission or its registered certifying agency under the Act and any subsidiary legislations made under the Act, shall be used or operated in the frequency band specified in the class assignments, and the certified devices shall bear a certification label as approved by the Commission [Conditions 4(1)(h)]

RM100K / 2 months / both

PENALTY FOR OFFENCES

APPOINTMENT & ACCREDITATION

3. COMPLIANCE APPROVAL

HYBRID PRODUCTAny hardware or device integrated with communication module for connecting to public communication network or for radiocommunications utilizing band up to 420 THz. (i.e: Wi-Fi, Bluetooth, ANT, NFC, Zigbee, WPT, RFID, LoRA, NB-IoT, GSM, 3G, 4G LTE, 5G )

Subjected to multiple regulations and requirements.

COMMUNICATION EQUIPMENTAny network facilities or customer equipment used for connecting to a public communications network or for radio communications using a frequency band of up to 420 THz.

CERTIFICATION SCOPES

INTRODUCTION ON HYBRID PRODUCT

PRODUCT COMPLIANCE IN MEDICAL INDUSTRY

Technical Code: 4) MCMC MTSFB TC T007:2014 (SRD)

Technical Code: 1) MCMC MTSFB TC T015:2017 (LTE)2) SKMM WTS IMT-MT (WCDMA)3) SKMM WTS GSM-MT (GSM)

Covered Scope: 1) Radio Frequency (RF)2) EMC3) Safety

Covered Scope: Radio Frequency (RF)

Covered Parameters: 1)Frequency range 2) Output Power (E.I.R.P) 3) Spurious Emission

WIRELESS MEDICAL DEVICE

WIRELESS OBTURATOR(Minimal Risk)

WIRELESS PHLEGM SUCTION(Low to Moderate Risk)

WIRELESS LUNG TRANSMITTER(Moderate to High Risk)

WIRELESS PACEMAKER(High Risk)

Customs (Prohibition of Imports) Order 2017

(16) Wireless heart rate sensor or stress test system

- Electro-cardiographs- Other

(17) Wireless digital blood pressure monitor

- Other

(18) Wireless digital blood pressure monitor

- Pacemakers for stimulating heart muscles, excluding parts and accessories

9018.11.00 009018.19.00 00

9018.19.00 00

9021.50.00 00

(19) Wireless medical device

- Ultrasonic scanning apparatus- Magnetic resonance imaging apparatus- Scintigraphic apparatus- Other- Computed tomography apparatus- Other, for dental uses- Other, for medical, surgical or veterinary uses- Other

9018.12.00 009018.13.00 009018.14.00 009018.19.00 009022.12.00 009022.13.00 009022.14.00 00

9022.19.90 00

TARIFF CODES FOR HYBRID MEDICAL PRODUCT

ACTIVE MEDICAL DEVICE (HYBRID-

MEDICAL)

ACTIVE MEDICAL IMPLANT (HYBRID-

MEDICAL)

MEDICAL DEVICE (HYBRID - MEDICAL)

DIGITAL BLOOD PRESSURE MONITOR (HYBRID - MEDICAL)

851770900852550200901890900902150000

8521909900901819000090189090009021500000

851762590851769900852550200901890900

9021500000852190990090181100009018909000851762590085219099009018190000

9018190090 8517180009018120000851762190851762910

8517629100901812000901819900901890900902213000

8517625100901812000090181300009018190000901910900090221300009022140000

TARIFF CODES FOR HYBRID MEDICAL PRODUCT USED(ePermit declaration)

only 7 of 10 Tariff Codes in Customs (Prohibition of Imports) Order 2017

used in ePermit declaration

*

STATISTIC OF COMMUNICATION EQUIPMENT IN MEDICAL INDUSTRY

Statistics/Years 2015 2016 2017 20182019(Jan - Dec)

TOTAL

Compliance Approval 134 145 94 82 840 1,295

Self Labelling Program

Serial NumberRegistration

351 3,798 3,185 2,822 6,247 16,403

IMEI NumberRegistration

0 5 4 22 264 295

Total 351 3,803 3,189 2,844 6,511

APPROVED HYBRID MEDICAL PRODUCT

TYPE OF PRODUCT TOTAL COMPLIANCE APPROVAL/ TAC

Medical Device (Hybrid - Medical) 385

Active Medical Implant (Hybrid-Medical) 200

Patient Monitoring Device (Hybrid -Medical) 69

Digital Radiography Image (X-Ray) (Hybrid - Medical) 30

APPROVED HYBRID MEDICAL PRODUCT

TYPE OF PRODUCT TOTAL COMPLIANCE APPROVAL/ TAC

Digital Blood Pressure Monitor (Hybrid-Medical) 17

Medical Device (GSM850/900/1800/1900/3G(900/2100)) (Hybrid-Medical)

16

Capsule Endoscope System (Hybrid-Medical) 12

Magnetic Resonance Imaging (Hybrid – Medical) 11

Skin Analyzer (Hybrid - Medical) 11

4. WAY FORWARD

5G Verticals and its Applications

• Remote Consultation• Remote Diagnosis

e-Health

• Smart Home• Smart Commute• Digital Mapping

• Virtual Conference

Smart City

• Smart Industry• Robotic Arm• 3D Printing

• Touch Drone• Smart Manufacturing

Factory / Manufacturing

• Jamming Session• VR Online Gaming• Multi 4K TV Screens• Hologram• VR Football• Holoportation• VR 360• VR Ping Pong

Media & Entertainment

• Autonomous Car• Big Data Analytics

Automotive

• Automotive Curriculum (via AR)

• VR Classroom• Smart IoT Campus

Education

• Drone Monitoring• High Resolution Surveillance• Robotic Arm

Public Safety

• Aquaculture• Crop Growth Monitoring and

Management

Agriculture

E-Health

Remote Diagnosis Remote Consultation

THANK YOU