Archives

img-01

Drug Master File (DMF) Systems in Asia

Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More

img-01

Asia Regulatory Updates

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

img-01

Quick Asian Drug Regulatory Updates

On July 31, 2024, the Taiwan Food and Drug Administration (TFDA) officially launched digital GMP certificates. These certificates comply with international PIC/S GMP standards and feature advanced encryption via a digital signature recognized by Taiwan’s Electronic Signatures Act and the global Adobe... Read More

img-01

Quick Asian Medical Device Regulatory News Briefs

India’s DCGI, on January 6 revised the device classification of 4 main device categories.  These categories include 186 interventional radiology devices, 114 radiotherapy devices, 75 Oncology devices, and 803 Class A Non-Sterile and Non-Measuring devices. Please remember that India classifies medical devices... Read More

img-01

More Medical Devices Manufactured in Asia

Over the last 20 years, Western medical device makers have had a boom in device exports to Asia. During that time, most Asian countries’ populations have gotten wealthier, seen more government investment in healthcare, seen new, more and advanced healthcare insurance programs... Read More

img-01

Taiwan’s TFDA Announces New Device Regulations

On November 27, 2023, Taiwan issued an amendment to the – Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration. Medical device registration in Taiwan includes two separate applications – 1. a dossier on the product and 2. a Quality... Read More