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

The Philippines FDA Streamlines Amendment Submission Process

On December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.

Korea Intends to Increase Medical Device Registration Fees in 2017

The Korean government has announced intentions to increase the official fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications.

The Philippines Appoints New FDA Director General

President Rodrigo Duterte appointed Charade Galang-Puno as the new Director General of the Philippines Food and Drug Administration. Dr. Galang-Puno is one of 42 appointees sworn in on Monday, August 15 at the Malacañang Palace in Manila.

New Regulations in India Raise the Bar for Many IVD Devices

The new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications.

Thailand FDA Publishes New Guidance on Post-Market Vigilance

The Thai Food and Drug Administration (FDA) has published a Notification clarifying post-market vigilance requirements referenced in sections 5 (1) and 41 (5) of the Medical Device Act B.E. 2551 (2008). The requirements are to go into effect in this November and are considered an important step toward harmonization of the Thai regulations with the ASEAN Medical Device Directive.