CDSCO medical device registration in India
A practical walk-through of MDR 2017 risk classification, the manufacture-vs-import licensing split, and the MD-14/MD-15 dossier requirements.
Read articleNotes on Indian regulatory practice, written for people who have to file.
A practical walk-through of MDR 2017 risk classification, the manufacture-vs-import licensing split, and the MD-14/MD-15 dossier requirements.
Read articleRoles, SAE/SUSAR reporting clocks to the Ethics Committee and CDSCO, causality assessment, and the safety documentation a sponsor or CRO should have ready.
Read articleRegistration expires, membership changes, and an untrained member is not a member. The obligations that keep running after the approval letter arrives.
Read articleForm CT-16 is the application and Form CT-17 is the licence. The delay is almost never customs; it is a dependency nobody put on the chart.
Read articleTwenty-four hours to report, fourteen days to analyse, ninety days to an order and thirty days to pay. The paying window opens on someone else's timing.
Read articleA waiver of local clinical trials is discretionary, not automatic. What the Subject Expert Committee is deciding is whether evidence generated elsewhere predicts what will happen to Indian patients.
Read articleEvery other start-up task can be late. Registration has to be complete before the first participant is enrolled, and there is no version of the schedule that recovers it afterwards.
Read articleTell us the molecule, the indication and where you are in the process. We will tell you what the realistic path and timeline look like.
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