Rule 8 MDR 2017 — The Jurisdiction Map Most Indian MedTech Manufacturers Have Never Read
The Wrong Authority Problem — How Indian MedTech Manufacturers Are Wasting Months Filing With the Wrong Regulator By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel A Class B medical device manufacturer filed their manufacturing licence application with CDSCO in New Delhi. They paid the fee. They submitted the documents through SUGAM. They waited. Four months later CDSCO informed them that Class B manufacturing licences are not issued by CDSCO. They are issued by the State Licensing Authority — the State Drug Controller of the state where the manufacturing site is located. They had been in the wrong queue for four months. Four months of investor runway consumed. Four months of delayed market entry. Four months of a mistake that a single careful reading of Rule 8 of MDR 2017 would have prevented entirely. This is not an unusual story. Versions of it happen regularly across Indian MedTech — not because manufacturers are careless but becau...