MDSAP explained: the five participating authorities, why Canada makes it mandatory, why the EU does not accept it, the seven-process audit model, the 2026 changes, and how EN ISO 13485 differs from ISO 13485.
04
Sep
What an Indian Authorised Agent does under the Medical Devices Rules 2017, the MD-14 to MD-15 pathway, agent liability, and why appointing your distributor as agent can cost you the Indian market.
EU IVDR 2017/746 explained: Annex VIII classification, transition deadlines to 2029, performance evaluation under Annex XIII, Class D obligations and EUDAMED registration.
EU MDR 2017/745 explained for non-EU manufacturers: transition deadlines to 2027 and 2028, the 27 November 2026 EUDAMED deadline, Authorised Representative and PRRC duties, and technical documentation.
What a US FDA 510(k) actually requires in 2026 - predicate selection, eSTAR, timelines, FY2026 fees, US Agent obligations and the new QMSR - explained by regulatory consultants who file them.
Introduction India’s medical device industry is rapidly evolving, with increasing regulatory focus on quality, safety, and stan...
Client Background This case study presents a Canada-based medical device legal and actual manufacturer engaged in the production...