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

Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR

Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.

Taiwan’s New TCP III in Effect as of January 1, 2022

The Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.

Philippines FDA Publishes Revised Draft of New IVD Regulations

The Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.

China Fully Implements UDI Requirements for Class 3 Medical Devices

Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.

Philippines’ FDA Issues Customs Clearance Guidance for Radiation Products

On June 3, 2022, the Philippines’ FDA issued Circular No.2017-013-A: amendment To FDA Circular No. 2017-013, titled, “Guidelines On The Issuance of Clearance for Customs Release (CFCR) of Radiation Devices by the Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR).” The amendment updates the guidance to align FDA Circular 2017-013 with DOH AO 2018-0002 and to help clarify the Clearance for Customs Release (CFCR) requirements for the industry and at the Bureau of Customs (BOC) for radiation products.

Philippines FDA Bans Mercury-Added Products

Released on June 13, 2022, the Philippines FDA released FDA Circular No.2022-003 banning the manufacture and sale of mercury-added products including thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes.

Singapore’s HSA Issues New Software as Medical Device (SAMD) Guidance

In April 2022, Singapore’s Health Science Authority (HSA) issued new guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore.

China Issues Recommendation for Medical Device Clinical Data

For medical device registration in China, one of the most important documents to be provided is  clinical data. 

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.

NMPA Issues New Guidance for Medical Device Software in China

In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.