A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

China NMPA Updates Compulsory Standards for Medical Devices

On November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.

India Grants Import License Grace Period for Class A/B Devices

Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.

China Publishes 9 Draft Guidelines for Registration of Medical Devices

Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.

Philippines FDA to Expedite Applications Approved Under AMDD-CSDT

Products approved under AMDD harmonized regulation with CSDT documentation are now eligible for an expedited review by the Philippines FDA.

TFDA Expands Reliance Route to Include All B/C/D Singapore Registrations

On June 1, 2022, the TFDA released an announcement outlining the expansion of the Singapore Reliance Route program. This allows manufacturers with Singapore approvals that used CSDT documentation to cut their review time down to 60 working days.

Singapore’s HSA to Increase Fees in July 2022

Singapore’s Health Science Authority (HSA) to increase review fees in July 2022 by about 3%.

Philippines FDA Issues New Draft IVD Regulations

The Philippines FDA released new draft IVD guidance for the public’s review and comment in early January 2022 which would harmonize their regulations with the ASEAN Medical Devices Directive (AMDD).

India Issues Final Notice Exempting Certain Class A Medical Devices

On October 14, 2022, the Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued final notification G.S.R. 777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the Import License (MD-15) process.  

Registering Innovative Medical Devices in India

Innovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.

China NMPA Updates Classification of Sodium Hyaluronate Products

On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.