Your FDA Clearance Is Not a Predicate in India
Your FDA Clearance Is Not a Predicate in India- What Global Manufacturers Get Wrong By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Most medical device companies entering India make the same assumption. "We have FDA clearance. We have a predicate. India will be straightforward." It is not straightforward. And the misunderstanding costs months — sometimes years. The Assumption That Breaks Applications When a manufacturer has US FDA 510(k) clearance, they have demonstrated substantial equivalence to a predicate device — a device previously cleared by FDA in the United States. That US predicate has no standing in India. India's regulatory framework under MDR 2017 defines predicate device independently, in Rule 3(zm): "A device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar Intended Use, Material of Construction and Design Cha...