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Medical Devices Rules, 2017
What it is
Effective Jan 2018, the first framework treating devices separately from drugs. Devices are classified A to D by risk on the GHTF model, with Class A/B licensed by states and Class C/D by CDSCO centrally
Manufacturers must run an ISO 13485 quality system; licences are perpetual subject to retention. Since Oct 2023 all Class C and D devices need a licence, ending the notified vs non-notified split
Impact on industries
- Closes a real safety gap - pacemakers and ventilators were effectively unregulated before, and classification is what makes exports and tenders defensible
- Raises barriers to entry in favour of organised manufacturers, since quality systems, clinical evaluation and dossiers are beyond an unorganised workshop
- Approval timelines are long and scale with risk class - up to 240 days for Class C and 365 for Class D - which delays launches and ties up product development capital
- Scope keeps widening through amendment, and separate BIS Scheme X certification with a Sep 2026 deadline adds a second compliance track for notified devices