Quick Asian News Briefs

In late March, the Philippines FDA (PFDA) has extended the registration date for Class B,C and D medical device registration for devices that were not already on the registrable medical device list. Now, these medical devices do not need to be registered until September 30, 2024. From October 1, 2024, all medical devices not registered or pending approvals, will not be eligible for sale in the Philippines.

Sharing a border, Malaysia and Singapore have renewed a 2012 agreement to share drug regulatory information. Included in this agreement is sharing of information regarding drug registration,  post market surveillance, enforcement of penalties for crimes, etc. This agreement will continue the cooperation between the Malay National Pharmaceutical Regulatory Division and the Singapore HSA. The overall goal is to promote Good Regulatory Practice  and improve the speed to regulate drug markets in both countries.

Indonesia, in May 2024, promulgated an Announcement regarding the Good Distribution Practices for Medical Devices (GDPMD). Basically, all Indonesian distributors need to have a GDPMD to be an authorized marketing agent and apply for device approval.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.