Philippines Incentivizes Local Medical Device Manufacturing
July 31st, 2024: Philippines established its first inaugural Pharma-Med Development Hub, which will contribute to local medical development.
Charmaine joined Asia Actual in 2015 as the Principal Consultant of Asia Actual in Manila. Charmaine is one of the most experienced regulatory affairs professionals in the country with more than 500 successful medical device application approvals to her credit. Prior to Asia Actual, Charmain spent more than 15 year leading medical device registration operations for multinational companies such as Terumo, Becton Dickinson, Baxter Healthcare and B. Braun.
Charmaine holds a BS degree in Pharmacy from Centro Escolar University and maintains certification as a Philippines FDA Qualified Person in Industry for medical devices, drugs and vaccines. Charmaine is one of the founders and officers of the Philippine Association of Medical Device Regulatory Professionals (PAMDRP) and is active as a medical mission volunteer to depressed areas of the Philippines.
July 31st, 2024: Philippines established its first inaugural Pharma-Med Development Hub, which will contribute to local medical development.
On April 5th, the CDRRHR provided guidance for CMDR medical device labeling in the Philippines related to previously CMDN labeled stock.
On November 29th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it’s corresponding Annexes.
The Philippines Center for Device Regulation, Radiation Health and Research (CDRRHR) has announced that Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to September 30, 2024.
Learn about the recent Virtual Regional Workshop on Good Regulatory Practices and Medical Device Regulation hosted by USAID, ANSI, and AdvaMed. Attendees gained valuable knowledge on navigating the complex world of medical device regulation, including discussions on specific GRPS, WHO global model regulatory framework updates, and country experiences with reliance models. Read on to discover the benefits of recognizing foreign conformity assessment results, transparency, predictability, inclusion, consistency, and accountability.
The Philippines FDA has issued a new report entitled “Guidelines on the Food and Drug Administration’s Regulatory Responses During Declared National or State Public Health Emergencies.”
On December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs).
On September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.
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.
The Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.
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