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

COLLABORATION ON CERTIFICATION FOR MEDICAL DEVICES INTEGRATED WITH COMMUNICATION CAPABILITY Date: 5 th March 2020 Venue: Tropicana Golf and Country Resort

1. OBJECTIVES

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

2. INTRODUCTION

ACTS & REGULATIONS <a href="htups://www.freepik.com/free-photos-vectors/infographic">Infographic vector created by katemangostar - www.freepik.com</a>

ACTS & REGULATIONS COMPLIANCE APPROVAL LABELING IMPORT PERMIT REQUIREMENTS Rules: Rules: Rules: Customs (Prohibitjon Of Import) Communicatjons and Multjmedia P.U.(A) 124 CMA 1998 Order 2017 (Technical Standards) Regulatjons TSR 2000 Regulatjon 22. 2000 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 or Technical Codes or Technical Declaratjon which are deemed fjt to P.U.(A) 124 CMA 1998 TSR 2000) the import and in accordance with the Communicatjons and Regulatjon 14 - 22 . Multjmedia Act 1998 , its subsidiary legislatjons, statutory requirements and established rules and procedures”.

PENALTY FOR OFFENCES LEGISLATIONS PROVISIONS PENALTY Hindering interoperability an ofgence [Sectjon.182] RM500K / 5 years / both Communicatjon Compromising public safety an ofgence [Sectjon.183] RM500K / 5 years / both and Multjmedia Act Emission from non-standard equipment or device [Sectjon.238] RM50K / 1 year / both 1998 Unlawful use, possession or supply of non-standard equipment or device [Sectjon.239] RM100K / 2 years / both All communicatjons equipment which are required to be certjfjed under these Regulatjons shall be RM100K / 6 months / both so certjfjed. [Regulatjon.14] No person shall intentjonally design, install, operate, maintain or modify any communicatjons Communicatjons & RM300K / 3 years / both equipment in a manner which is contrary to the standards [Regulatjon.15] Multjmedia (Technical No person shall use, ofger for sale, sell or have in his possession with a view to sell any RM100K / 6 months / both Standards) communicatjons equipment which is contrary to the standards [Regulatjon.16] Regulatjons 2000 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 RM100K / 6 months / both with the standards [Regulatjon. 22(a)] Class assignment shall ensure that only devices certjfjed by the Commission or its registered Class Assignments certjfying agency under the Act and any subsidiary legislatjons made under the Act, shall be used RM100K / 2 months / both 1/2019 or 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)]

APPOINTMENT & ACCREDITATION

3. COMPLIANCE APPROVAL

CERTIFICATION SCOPES 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. 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 .

INTRODUCTION ON HYBRID PRODUCT

PRODUCT COMPLIANCE IN MEDICAL INDUSTRY 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 Technical Code: 4) MCMC MTSFB TC T007:2014 (SRD) Covered Scope: Radio Frequency (RF) Covered Parameters: 1)Frequency range 2) Output Power (E.I.R.P) 3) Spurious Emission

WIRELESS MEDICAL DEVICE WIRELESS PHLEGM SUCTION WIRELESS OBTURATOR (Low to Moderate Risk) (Minimal Risk) WIRELESS LUNG TRANSMITTER WIRELESS PACEMAKER (Moderate to High Risk) (High Risk)

TARIFF CODES FOR HYBRID MEDICAL PRODUCT Customs (Prohibition of Imports) Order 2017 (16) Wireless heart rate sensor or stress test (19) Wireless medical device system 9018.12.00 00 - Ultrasonic scanning apparatus 9018.11.00 00 - Electro-cardiographs 9018.13.00 00 - Magnetjc resonance imaging apparatus 9018.19.00 00 - Other 9018.14.00 00 - Scintjgraphic apparatus 9018.19.00 00 - Other (17) Wireless digital blood pressure monitor 9022.12.00 00 - Computed tomography apparatus 9022.13.00 00 - Other, for dental uses 9018.19.00 00 - Other 9022.14.00 00 - Other, for medical, surgical or veterinary uses (18) Wireless digital blood pressure monitor 9022.19.90 00 - Other 9021.50.00 00 - Pacemakers for stjmulatjng heart muscles, excluding parts and accessories

TARIFF CODES FOR HYBRID MEDICAL PRODUCT USED (ePermit declaration) ACTIVE MEDICAL ACTIVE MEDICAL MEDICAL DEVICE DIGITAL BLOOD PRESSURE MONITOR DEVICE (HYBRID- IMPLANT (HYBRID- (HYBRID - MEDICAL) (HYBRID - MEDICAL) MEDICAL) MEDICAL) 851770900 851762590 9018190090 851718000 8517625100 852550200 851769900 9018120000 9018120000 901890900 852550200 851762190 9018130000 902150000 901890900 851762910 9018190000 8521909900 9021500000 8517629100 9019109000 9018190000 8521909900 901812000 9022130000 9018909000 9018110000 901819900 9022140000 9021500000 9018909000 901890900 8517625900 902213000 8521909900 9018190000 only 7 of 10 Tarifg Codes in Customs * (Prohibitjon of Imports) Order 2017 used in ePermit declaratjon

STATISTIC OF COMMUNICATION EQUIPMENT IN MEDICAL INDUSTRY 2019 Statjstjcs/Years 2015 2016 2017 2018 (Jan - TOTAL Dec) Compliance Approval 134 145 94 82 840 1,295 Serial Number 351 3,798 3,185 2,822 6,247 16,403 Registratjon Self Labelling IMEI Number Program 0 5 4 22 264 295 Registratjon 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 30 Digital Radiography Image (X-Ray) (Hybrid - Medical)

APPROVED HYBRID MEDICAL PRODUCT TYPE OF PRODUCT TOTAL COMPLIANCE APPROVAL/ TAC Digital Blood Pressure Monitor (Hybrid-Medical) 17 16 Medical Device (GSM850/900/1800/1900/3G(900/2100)) (Hybrid-Medical) 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 Media & Entertainment • Jamming Session • VR Online Gaming e-Health • Multj 4K TV Screens • Remote Consultatjon • Hologram • Remote Diagnosis • VR Football Smart City • Holoportatjon • Smart Home • VR 360 • Smart Commute • VR Ping Pong • Digital Mapping • Virtual Conference Automotjve Factory / Manufacturing • Autonomous Car • Smart Industry • Big Data Analytjcs • Robotjc Arm • 3D Printjng • Touch Drone Public Safety • Smart Manufacturing • Drone Monitoring • High Resolutjon Surveillance Educatjon • Robotjc Arm • Automotjve Curriculum (via AR) Agriculture • VR Classroom • Aquaculture • Smart IoT Campus • Crop Growth Monitoring and Management

E-Health Remote Consultatjon Remote Diagnosis

THANK YOU