Medical Devices-Asia Regulatory News Roundup, Nov 2022

INDIA

1. Updated List of Medical Device Testing Laboratories (MDTL)

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has updated its list of Medical Device Testing Laboratories (MDTLs). These laboratories are registered under the Medical Device Rules (MDR) 2017 and are authorized to conduct testing or evaluation of medical devices on behalf of manufacturers. The updated list reflects all facilities currently registered to perform such assessments.

MALAYSIA (MDA)

2. Sixth Edition Guidance Document MDA/GD/0026 – Requirements for Labelling of Medical Devices

The Medical Device Authority (MDA) has issued the sixth edition of its guidance document on labelling requirements for medical devices. This document supports industry stakeholders and healthcare professionals in complying with the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. It should be read alongside all applicable Malaysian laws and regulatory frameworks.

3. Fourth Edition Guidance Document MDA/GD/0020 – Change Notification for Registered Medical Devices

MDA has published the fourth edition of its change‑notification guidance. This document outlines the categories of changes applicable to registered medical devices and specifies the requirements manufacturers must meet to continue importing, exporting, or placing devices on the Malaysian market following a modification.

BAHRAIN (NHRA)

4. Circular No. (35) 2022 – Reminder on Authorized Representative Registration Deadline

The National Health Regulatory Authority (NHRA) of Bahrain has issued Circular No. (35) 2022 to remind medical device importers and suppliers of the mandatory requirement to obtain an Authorized Representative license. Establishments without the required NHRA license will have the commercial activity “Sale/Trade in other machinery and equipment and parts – medical devices, supplies and related spare parts” automatically removed from their Commercial Registration starting January 2023, in line with Circular No. 39 of 2020..