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 eServices Portal System on or after March 10, 2025. This is a move to better streamline the compliance aspects of the medical industry. A CMDN document assures that before a medical device may be legally marketed and sold, it is compliant with the recognized standards of safety, quality, and performance. Class A medical devices include low-risk products such as elastic bandages, non-powered wheelchairs, digital thermometers, surgical masks, and standard wound dressing.
The Taiwan Ministry of Health and Welfare (MOHW) has unveiled a variety of draft regulations under the Regenerative Medicine Act and the Regenerative Medicine Product Act that were passed in June 2024. These regulations will be critical in defining the regulatory framework in Taiwan for treatments using regenerative medicine. The MOHW published six draft regulations on February 17, 2025, under the Regenerative Medicine Act, on a range of topics that include review committee functioning, research incentives, treatment management, informed consent, advertising, and reporting of adverse reactions. In addition, between August 2024 and February 2025, four draft regulations under the Regenerative Medicine Product Act were released, covering safety monitoring, supply chain retention of data, advertising, and informed consent by tissue and cell providers. There is a 60-day public consultation period for all draft regulations. The MOHW has targeted the end of 2025 to finalize these regulations and implement the entire regulatory framework.
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.