Medical Devices – Asia Regulatory Updates Roundup, Sep 2022

Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures

‘Non-Sterile and Invasive Surgical Instruments’ are commonly intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be used after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.

Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as per G.S.R. 102(E) dt 11.02.2020

If an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing license of the device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time.

Announcement of the review results of the special review application for innovative medical devices (2022 No. 7)

In accordance with the requirements of the State Drug Administration’s “Special Review Procedures for Innovative Medical Devices” (Announcement No. 83 of 2018 of the State Food and Drug Administration), the Innovative Medical Device Review Office organized relevant experts to review the application for special review of innovative medical devices, and intends to agree to the following The application project has entered the special review process and is now publicized.

Expert members of the Medical Device Board (MDB)

In exercise of the powers conferred by sub –rule (2) of rule 59 of the Medical Devices Rules,2017, the Drug Regulatory authority of Pakistan is pleased to nominate the expert members of the Medical device board (MDB) for a period of two years, namely.

Licensing For Establishment

The requirement for establishment license is specified under the Section 15 of the Medical Device Act 2012 (Act 737). All establishments as defined in Section 2 of the Act 737 shall obtain a license/ licenses before they can import, export or place a medical device in the market. This guidance document is prepared to provide guidance on licensing requirements for establishments dealing with medical devices in Malaysia, in complying with the Medical Device Act and regulation.

Guideline For Re-Registration Of Registered Medical Device

The guidance provides information and explanation to the establishment on how to submit re-registration of registered medical device application under Act 737 and MDR 2012. The guideline covers all medical device classes and it is applicable to any person who is required by the Act to register any medical device.

Status Of Designation Of Medical Device Non-Clinical Testing Institutions

In accordance with Article 24-2, Paragraph 7 of the Enforcement Regulations of the Medical Device Act, the “Status of Designation of Medical Device Non-Clinical Testing Institutions (As of 22.9.22)” is announced as an attachment.