COLLABORATION ON CERTIFICATION FOR MEDICAL DEVICES INTEGRATED WITH - - PowerPoint PPT Presentation

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

COLLABORATION ON CERTIFICATION FOR MEDICAL DEVICES INTEGRATED WITH COMMUNICATION CAPABILITY

• 1. OBJECTIVES

Enhance awareness and increase control over the certjfjcatjon and importatjon of communicatjon, multjmedia and hybrid products in the medical sector Protect the spectrum from frequency interference and preserve the quality of telecommunicatjons service. Protect consumers from unsafe, faulty, substandard or counterfeit/cloned products through certjfjcatjon. To share on the Check Your Label (CYL) campaign in creatjng public awareness on certjfjed communicatjon devices. To response on inquiries and provide clarifjcatjons on the regulatory and certjfjcatjon requirements.

OBJECTIVES

• 2. INTRODUCTION

ACTS & REGULATIONS

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LABELING Rules:

P.U.(A) 124 CMA 1998 TSR 2000 Regulatjon 22.

IMPORT PERMIT REQUIREMENTS

Manner of Import for Products with tarifg code assigned to SIRIM: “That the import is accompanied by a Certjfjcate of Approval issued by SIRIM. The import shall be certjfjed to the Malaysian Standards

• r Technical Codes or Technical Declaratjon which are deemed fjt to

the import and in accordance with the Communicatjons and Multjmedia Act 1998, its subsidiary legislatjons, statutory requirements and established rules and procedures”.

Rules:

Customs (Prohibitjon Of Import) Order 2017

COMPLIANCE APPROVAL Rules:

Communicatjons and Multjmedia (Technical Standards) Regulatjons 2000 P.U.(A) 124 CMA 1998 TSR 2000) Regulatjon 14 - 22.

ACTS & REGULATIONS

LEGISLATIONS PROVISIONS PENALTY Communicatjon and Multjmedia Act 1998

Hindering interoperability an ofgence [Sectjon.182] RM500K / 5 years / both Compromising public safety an ofgence [Sectjon.183] RM500K / 5 years / both Emission from non-standard equipment or device [Sectjon.238] RM50K / 1 year / both Unlawful use, possession or supply of non-standard equipment or device [Sectjon.239] RM100K / 2 years / both

Communicatjons & Multjmedia (Technical Standards) Regulatjons 2000

All communicatjons equipment which are required to be certjfjed under these Regulatjons shall be so certjfjed. [Regulatjon.14] RM100K / 6 months / both No person shall intentjonally design, install, operate, maintain or modify any communicatjons equipment in a manner which is contrary to the standards [Regulatjon.15] RM300K / 3 years / both No person shall use, ofger for sale, sell or have in his possession with a view to sell any communicatjons equipment which is contrary to the standards [Regulatjon.16] RM100K / 6 months / both All certjfjed communicatjons equipment bears a certjfjcatjon mark or label approved by the Commission or a registered certjfying agency, as the case may be, so as to indicate that it complies with the standards [Regulatjon. 22(a)] RM100K / 6 months / both

Class Assignments 1/2019

Class assignment shall ensure that only devices certjfjed by the Commission or its registered certjfying agency under the Act and any subsidiary legislatjons made under the Act, shall be used

• r operated in the frequency band specifjed in the class assignments, and the certjfjed devices

shall bear a certjfjcatjon label as approved by the Commission [Conditjons 4(1)(h)] RM100K / 2 months / both

PENALTY FOR OFFENCES

APPOINTMENT & ACCREDITATION

• 3. COMPLIANCE APPROVAL

HYBRID PRODUCT

Any hardware or device integrated with communicatjon module for connectjng to public communicatjon network or for radiocommunicatjons utjlizing 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 multjple regulatjons and requirements.

COMMUNICATION EQUIPMENT

Any network facilitjes or customer equipment used for connectjng to a public communicatjons network or for radio communicatjons 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) EMC 3) 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 stjmulatjng heart muscles,

excluding parts and accessories 9018.11.00 00 9018.19.00 00 9018.19.00 00 9021.50.00 00 (19) Wireless medical device

• Ultrasonic scanning apparatus
• Magnetjc resonance imaging apparatus
• Scintjgraphic apparatus
• Other
• Computed tomography apparatus
• Other, for dental uses
• Other, for medical, surgical or veterinary

uses

• Other

9018.12.00 00 9018.13.00 00 9018.14.00 00 9018.19.00 00 9022.12.00 00 9022.13.00 00 9022.14.00 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) 851770900 852550200 901890900 902150000 8521909900 9018190000 9018909000 9021500000 851762590 851769900 852550200 901890900 9021500000 8521909900 9018110000 9018909000 8517625900 8521909900 9018190000 9018190090 851718000 9018120000 851762190 851762910 8517629100 901812000 901819900 901890900 902213000 8517625100 9018120000 9018130000 9018190000 9019109000 9022130000 9022140000

TARIFF CODES FOR HYBRID MEDICAL PRODUCT USED

(ePermit declaration)

• nly 7 of 10 Tarifg Codes in Customs

(Prohibitjon of Imports) Order 2017 used in ePermit declaratjon *

STATISTIC OF COMMUNICATION EQUIPMENT IN MEDICAL INDUSTRY

Statjstjcs/Years 2015 2016 2017 2018 2019 (Jan - Dec) TOTAL Compliance Approval 134 145 94 82 840 1,295 Self Labelling Program Serial Number Registratjon 351 3,798 3,185 2,822 6,247 16,403 IMEI Number Registratjon 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 Actjve Medical Implant (Hybrid-Medical) 200 Patjent 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 Magnetjc Resonance Imaging (Hybrid – Medical) 11 Skin Analyzer (Hybrid - Medical) 11

• 4. WAY FORWARD

5G Verticals and its Applications

• Remote Consultatjon
• Remote Diagnosis

e-Health

• Smart Home
• Smart Commute
• Digital Mapping
• Virtual Conference

Smart City

• Smart Industry
• Robotjc Arm
• 3D Printjng
• Touch Drone
• Smart Manufacturing

Factory / Manufacturing

• Jamming Session
• VR Online Gaming
• Multj 4K TV Screens
• Hologram
• VR Football
• Holoportatjon
• VR 360
• VR Ping Pong

Media & Entertainment

• Autonomous Car
• Big Data Analytjcs

Automotjve

• Automotjve Curriculum (via

AR)

• VR Classroom
• Smart IoT Campus

Educatjon

• Drone Monitoring
• High Resolutjon Surveillance
• Robotjc Arm

Public Safety

• Aquaculture
• Crop Growth Monitoring and

Management

Agriculture

E-Health

Remote Diagnosis Remote Consultatjon

THANK YOU