On 28 June 2026 the Ministry of Health and Family Welfare published a draft notification in the Official Gazette proposing amendments to the Medical Devices Rules, 2017 to shorten manufacturing licence timelines. The draft is open for 30 days of public comment via the Central Drugs Standard Control Organisation (CDSCO).
Medical device classification
- Risk classes: Four-tier risk classification under the Rules — Class A (low) to Class D (highest).
- Examples: Class B — blood pressure monitors, pulse oximeters; Class C/D — cardiac stents, hip implants.
Timelines by risk class
- Class B: Proposed reduction of manufacturing licence timeline from 140 days to 115 days.
- Class C & D: Proposed reduction from 105 days to 90 days.
- Stage-wise timelines: Draft specifies deadlines for application scrutiny, notified-body audits, compliance verification and licence issuance.
Rule-level changes
- Rule 25(1): Time to grant a licence after receipt of inspection report reduced from 45 days to 20 days.
- Rule 23(1): Inspection period for Class C/D manufacturing sites reduced from 60 days to 55 days.
Consultation and procedure
- Gazette publication: Draft notification published on 28 June 2026.
- Public comment: 30-day submission window managed by CDSCO.
IASPOINT Booster Facts
- Statute: Medical Devices Rules, 2017 issued under the Drugs and Cosmetics Act, 1940.
- Regulator: CDSCO is the national competent authority for medical devices in India.
- Global alignment: Risk-based four-class model mirrors international regulatory practice for device oversight.