Medical Devices-Asia Regulatory News Roundup, Nov 2022

INDIA (CDSCO)

1. List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017
This Directorate general of health service, Central Drug Standard Control Organization had registered a Medical Device Testing Laboratory (MDTL) to carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017. 
The updated list of medical devices testing laboratories registered with CDSCO, under the provisions of Medical Device Rules, 2017 to carry out test or evaluation of medical device on behalf of the manufacturer.

MALAYSIA (MDA)

2. Sixth edition guidance document MDA/GD/0026:Requiremets for Labelling of medical devices
Medical Device Authority (MDA) has prepared this guidance document to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it. This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following:

• Medical Device Act 2012 (Act 737); 
• Medical Device Regulations 2012.

3. Fourth edition guidance document MDA/GD/0020:Change notification for registered medical device
Medical Device Authority (MDA) has prepared this guidance document to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it. 
The guidance document specifies the categories of changes in relation to registered medical devices and the requirements to be met to continue the importation, exportation or placement of the medical devices in the market.

BAHRAIN (NHRA)

4. Circular No. (35) 2022: To All Medical Devices Importers and Suppliers – Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registration 
NHRA Bahrain has published Circular No. (35) 2022 to all medical device Importers and suppliers.
National Health Regulatory Authority would like to point out the importance of obtaining Authorized Representative license, as the commercial activity “Sale / Trade in other machinery and equipment and parts-medical devices, supplies and related spare parts” will be automatically deleted from the Commercial Registration of those establishments with no NHRA license starting from January 2023 based on Circular No. 39 for the year 2020.