Medical Devices–Asia Regulatory Updates Roundup, Aug 2022

INDIA (CDSCO)

List of Notified Bodies registered with CDSCO under MDR, 2017

CDSCO has published list of Notified Bodies registered with CDSCO under MDR 2017.

Medical Device Rules 2017 has already been published G.S.R.78 (E) dated 31.01.2017 under Drugs and Cosmetic Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01.01.2018.

The notified bodies registered with CDSCO under provisions Medical Devices Rules, 2017 to carry out audit of manufacturing site under the provisions of said rules. In this connection, following Notified Bodies have been registered with CDSCO:

List of the Certified Medical Device Testing Laboratory under MDR, 2017

CDSCO has published List of the Certified Medical Device Testing Laboratory (MDTL) under MDR, 2017. This office had registered a Medical Device Testing Laboratory (MDTL) to carryout test or evaluation of a medical device on behalf of the manufacturer (Form MD-40 of MDR, 2017). There are 18 MDTLs have been registered with CDSCO till dated 07.12.2021 under the provisions of the medical device rules 2017 (Form MD-40 enclosed).

Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017

CDSCO has published the Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017 regarding. Safety, quality and performance of medical devices are regulated under provisions of Drugs and Cosmetics Act, 1940. In exercise of the powers conferred under sub rule (3) of rule 4 of Medical devices rules, 2017, the undersigned classifies the medical devices on the intended use of device, risk associated with device and other parameters specified in the first schedule.

CHINA (NMPA)

Circular of the Center for Device Review of the State Food and Drug Administration on Issuing the Guiding Principles for the Registration Review of Quantitative In Vitro Diagnostic Reagent Analysis Performance Evaluation (2022 No. 32)

In order to further standardize the management of in vitro diagnostic reagents for quantitative detection, the Center for Device Review of the State Food and Drug Administration organized and formulated the “Guidelines for the Registration and Review of the Evaluation of Analytical Performance of In vitro Diagnostic Reagents for Quantitative Detection”

Announcement of the State Food and Drug Administration on Matters Concerning the Filing of Class I Medical Devices (2022 No. 62)

In order to do a good job in the filing of Class I medical devices, according to the “Regulations on the Supervision and Administration of Medical Devices” (Order No. 739 of the State Council), “Administrative Measures for Registration and Filing of Medical Devices”. The Administrative Measures for the Registration and Filing of Diagnostic Reagents (Order No. 48 of the State Administration for Market Regulation), the matters concerning the filing of Class I medical devices (including Class I in vitro diagnostic reagents)

HONG KONG (MDACS)

Announcement of the changes to the respective trial schemes for accepting marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System (MDACS)

Application forms for the captioned schemes have been updated. The concerned document is now available on MDD website

https://www.mdd.gov.hk/en/useful-information/forms/index.html
https://www.mdd.gov.hk/en/whats-new/mdacs-activities/index-id-2306.html

SINGAPORE (HSA)

UPDATE: Potential Increase Of Mortality And Amputation Risk Associated With Paclitaxel-Coated Devices

Singapore’s Health Sciences Authority (HSA) has updated its advice on paclitaxel-coated medical devices based on a systematic review and meta-analysis that found a higher risk of amputation in limbs treated with paclitaxel-coated balloons (PCBs).

SOUTH KOREA (MFDS)

Notification of changes to medical device technical document review institutions (Korea Medical Device Safety Information Service)

In accordance with Article 15-2 (designation of technical document review organization, etc.) of the Enforcement Rule of the Medical Device Act It is informed that the representative of the medical device technical document review organization has been changed as attached.

SAUDI ARABIA (SFDA)

Medical Devices and Supplies Facility Licensing Requirements (MDS-REQ9)

SFDA has published guideline on Medical Devices and Supplies Facility Licensing Requirements (MDS-REQ9) For More information on the Guideline check the Link below.

Table of classification of violations and penalties prescribed for them according to the system of medical devices and supplies and its executive regulations

SFDA has published guideline on Table of classification of violations and penalties prescribed for them according to the system of medical devices and supplies and its executive regulations.

AUSTRALIA (TGA)

Application for priority applicant determination – medical device

TGA has Updated application form for priority application determination – medical devices.