Regulatory Requirements for Medical Device Sterilization in India
Three obligations are taken on by a manufacturer that supplies a sterile device in India. The process has to be […]
Regulatory Updates
FDA PMA eSTAR Draft Guidance: What Sponsors Need to Know
On September 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER)
HSA Guidance on Class 2 CTGTP Registration in Singapore
Advanced medicines, such as cell, gene, and tissue-engineered therapies, are revolutionizing modern medicine. In Singapore, Cell, Tissue, or Gene Therapy
HSA Singapore Investigational Product Management Guidance
For locally registered products in Singapore, the management of investigational product (IP) for clinical trials is the most critical step,
Thai FDA Updates Medical Device Advertising Rules – Jan, 2025
The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License
COFEPRIS Simplifies Medical Device Registration in Mexico (2025)
New Regulatory Agreement by COFEPRIS for Simplification of Medical Device Registration Procedures and Shorter Timelines in Mexico: The Federal Committee
ANVISA Updates Drug Registration Process in Brazil
The Brazilian health authority ANVISA (Agência Nacional de Vigilância Sanitária) has recently updated the drug registration process in Brazil. The
Mexico COFEPRIS Updates on Medical Devices, Tariffs & Fees(December 2025)
Overview of December 2025 Regulatory Changes in Mexico Low risk Medical Device listing, application criteria as per the Q&A document