The Food and Drug Administration of the Philippines (Philippines FDA) officially declared that for Class A medical devices, the online application process to obtain the Certificate of Medical Device Notification (CMDN) is now the official route. Applicants must submit all CMDN applications through the... Read More
In late 2024, the FDA of the Philippines outlined a new regulation for all companies importing, exporting, manufacturing, and selling medical products. This new Administrative Order is Order #2024-0015, an update from an older 2020 regulation. The new order covers all types... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
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... Read More
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... Read More
With tensions between the US and China still very high, many Western medical companies are looking for alternative places to make their products. Medical companies have looked more aggressively to Vietnam and India as new manufacturing hubs over the last few years. Not... Read More
1. Overview The Philippines Food and Drug Administration operates as a regulatory body within the Filipino government’s Department of Health. Its primary responsibility is to ensure the safety, efficacy, and quality of various health products including, drugs, medical devices, food, cosmetics, biologicals,... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More