In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
A list of recently published and updated articles regarding medical device regulatory updates from the PFDA and other governing bodies in the Philippines.
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 March 31st, 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.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
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).
The Philippines FDA released new draft IVD guidance for the public’s review and comment in early January 2022 which would harmonize their regulations with the ASEAN Medical Devices Directive (AMDD).
Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”
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.
Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”