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

Philippines FDA Issues New Draft IVD Regulations

/in , /by

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).

Read more

India Issues Final Notice Exempting Certain Class A Medical Devices

/in , /by

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.  

Read more

Registering Innovative Medical Devices in India

/in , /by

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

Read more

China NMPA Updates Classification of Sodium Hyaluronate Products

/in , /by

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

Read more

China Releases Draft Clinical Evaluation Exemption List for 2022

/in , /by

On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.

Read more

India Requires Mandatory Local BIS Certifications for Certain Medical Devices

/in , /by

This blog serves as an important enforcement notice for manufacturers/importers that BIS certification is required for some of the electronic components/accessories included in medical devices, including batteries, monitors, power adaptors and more.

Read more

UDI Labelling Mandatory for Certain Taiwan Medical Devices

/in , /by

In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.

Read more

India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline

/in , /by

On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.

Read more

Vietnam’s DMEC Provides Update on Issuance of C/D Licenses

/in , /by

On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.

Read more

The Vietnamese MOH Issues Draft Decree to Address Delays

/in , /by

On November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to amend a number of articles from a previous decree related to the registration of medical devices.

Read more