Medical Devices–Asia Regulatory Updates Roundup, Aug 2022

INDIA (CDSCO)

CDSCO Publishes List of Notified Bodies under MDR 2017

The Central Drugs Standard Control Organization (CDSCO) has released the list of Notified Bodies registered under the Medical Device Rules (MDR), 2017. These rules, issued via G.S.R. 78(E) on January 31, 2017, under the Drugs and Cosmetics Act, regulate the manufacture, import, sale, and distribution of medical devices and took effect on January 1, 2018. The registered Notified Bodies are authorized to audit manufacturing sites as per these rules.

List of Certified Medical Device Testing Laboratories under MDR 2017

CDSCO has published the list of certified Medical Device Testing Laboratories (MDTLs) under MDR 2017. These laboratories are authorized to conduct testing or evaluations of medical devices on behalf of manufacturers in accordance with Form MD-40. As of December 7, 2021, 18 MDTLs have been registered with CDSCO.

Classification of Rehabilitation Medical Devices under MDR 2017

CDSCO has released classifications for rehabilitation-related medical devices under MDR 2017. Exercising powers under Rule 4(3), the classification considers the intended use, associated risks, and parameters listed in the First Schedule to ensure safety, quality, and performance compliance under the Drugs and Cosmetics Act, 1940.

CHINA (NMPA)

Guidelines for Registration Review of Quantitative In Vitro Diagnostic Reagents

The National Medical Products Administration (NMPA) has issued guidelines titled “Registration and Review of Analytical Performance Evaluation of Quantitative In Vitro Diagnostic Reagents” (2022 No. 32) to standardize quantitative IVD reagent management.

Filing Requirements for Class I Medical Devices

In Announcement No. 62 (2022), the NMPA detailed procedures for filing Class I medical devices and Class I IVD reagents, aligning with the “Regulations on the Supervision and Administration of Medical Devices” (State Council Order No. 739) and related administrative measures.

HONG KONG (MDACS)

Updates to Trial Schemes for Accepting Overseas Marketing Approvals

The Hong Kong Medical Device Division (MDD) has announced updates to its trial schemes under the Medical Device Administrative Control System (MDACS). These changes concern acceptance of marketing approvals from China’s NMPA and South Korea’s MFDS. Updated application forms and related documents are now available on the MDD website.

SINGAPORE (HSA)

Update on Paclitaxel-Coated Devices: Risk of Mortality and Amputation

Singapore’s Health Sciences Authority (HSA) has revised its advisory on paclitaxel-coated medical devices following a systematic review and meta-analysis that revealed increased risks of amputation in patients treated with paclitaxel-coated balloons (PCBs).

SOUTH KOREA (MFDS)

Notification on Changes to Medical Device Technical Document Review Institutions

The Ministry of Food and Drug Safety (MFDS) has announced updates regarding the designation of representatives for medical device technical document review organizations under Article 15-2 of the Enforcement Rule of the Medical Device Act.

SAUDI ARABIA (SFDA)

Guideline on Facility Licensing Requirements for Medical Devices and Supplies

The Saudi Food and Drug Authority (SFDA) has published the “Medical Devices and Supplies Facility Licensing Requirements (MDS-REQ9)” guideline.

Classification of Violations and Penalties

SFDA also issued a guideline outlining classifications of violations and their respective penalties under the system of medical devices and supplies and its implementing regulations.

AUSTRALIA (TGA)

Updated Application Form for Priority Medical Device Determination

Australia’s Therapeutic Goods Administration (TGA) has updated the application form for priority applicant determination for medical devices, streamlining the process for faster regulatory review.

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