Recently, the Filipino FDA initiated a new pilot device registration system called the eServices Portal System. This announcement is under the FDA’s Advisory No. 2024 – 1089 II Pilot program. Basically, applicants for device approval need to be licensed medical device establishments with offices in the National Capital Region. The pilot program will cover all initial Class A, B, C, and D devices that are not covered by FC No 2020 – 001 – A. The pilot program will begin on August 12 and end on October 11 of this year.
Companies that have recently submitted applications to the existing ePortal System are not required to also submit to the new eServices Portal System. However, if the device applicant really wants to try the eServices Portal System and has already paid a fee for the ePortal System, they can still apply for the sServices Portal System but will need to pay another fee. The Filipino FDA is hoping this new medical device portal system will be successful and if so, it will provide a lot more details on the eServices Portal System as they roll out the program nationwide.
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.