Regulatory News
Follow medical device and IVD regulatory updates, implementation guidance, and practical interpretations for major markets.
Regulatory news
Regulatory news for medical devices and IVDs across major markets, updated regularly.
Saudi Arabia's new MDS-G30 guidance establishes an SFDA reliance pathway for eligible MDMA applications supported by approvals from recognized regulatory authorities.
FDA's September 2026 draft guidance signals a structured electronic submission framework for original PMAs and selected PMA supplements. Here is what high-risk medical device manufacturers should prepare now.
What medical device and IVD manufacturers should know about FDA's new risk-based human factors documentation framework and the updated eSTAR 7.0 submission templates.
A market-entry planning brief covering classification, evidence strategy, quality documentation, and post-market preparation for Japan.
A practical data-governance checklist for manufacturers preparing EUDAMED-related information and life-cycle regulatory records.
What the FDA Quality Management System Regulation means for medical device manufacturers aligning quality processes with ISO 13485 concepts.
A readiness note on licence maintenance, quality system evidence, and change control for Canadian medical device and IVD market access.
A concise planning brief for manufacturers preparing device and IVD registrations, local documentation, and post-market compliance in Brazil.
Key planning points for Australian medical device and IVD market access, including classification, conformity assessment evidence, sponsorship and ARTG inclusion.
A regulatory readiness checklist for connected devices and software functions submitted to the United States.
Key documentation, clinical evaluation, and change-control considerations for IVD products preparing for China market entry.
A practical watchlist for manufacturers preparing EU medical device and IVD technical documentation, EUDAMED data, and post-market obligations.