MD-42 Wholesale Registration: Who Needs It and How to Get It
A manufacturing or import licence does not let you sell onward. MD-42 wholesale registration does. Who needs it, what the application requires, and where it goes wrong.
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BIS Certification or CDSCO Licence: Which Does Your Medical Device Need?
BIS and CDSCO are not alternatives. Two authorities, two separate questions, and a product can need one, both or neither. How to work out which applies to yours.
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MDSAP Audit Preparation: The Seven Processes, Grading and What It Costs
What an MDSAP audit actually examines: the seven-process model, how nonconformities are graded numerically, realistic cost and timeline, and how to prepare.
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FDA in September 2026: radiology AI keeps its 510(k), and eSTAR moves towards PMAs
FDA denied a 510(k) exemption for radiology CAD and CADt software, proposed eSTAR for PMAs and opened a robotics draft guidance. Three actions, two comment deadlines in November.
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EUDAMED: the 28 November 2026 deadline for devices already on the EU market
EUDAMED registration for devices already on the EU market closes on 28 November 2026. What MDR and IVDR manufacturers, authorised representatives and importers must check now.
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MDSAP and EN ISO 13485: One Audit, Five Markets
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.
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Indian Authorised Agent for Medical Devices: CDSCO Guide
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.
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EU IVDR 2017/746: Compliance Guide for IVD Manufacturers
EU IVDR 2017/746 explained: Annex VIII classification, transition deadlines to 2029, performance evaluation under Annex XIII, Class D obligations and EUDAMED registration.
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EU MDR 2017/745: Compliance Guide for Manufacturers (2026)
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.
