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

Korea MFDS Implements Medical Device Monthly Reporting Requirements

The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.

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.

Taiwan FDA Medical Device Advertising Requirements

The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications

Taiwan FDA Launches New ePortal for Medical Device Applications

The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications

Thai FDA Announces New Application and Query Response Timelines

On April 4, 2022, the TFDA updated their application query response policy to expedite reviews of applications and clear out a backlog of open applications.

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%.

China to Require All Electromedical Devices Meet Updated Standards

This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

Singapore’s HSA Removes Classification and Grouping Inquiry Option

Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.

TFDA Updates Review Timelines for Medical Device Applications

A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.

Philippines FDA Issues New Guidance for Vet Products

The Philippines FDA released an advisory stating veterinary products and medical devices will now be handled exclusively by the CDRR.