Health Ministry proposes shorter licensing timelines under Medical Devices Rules, 2017
The Ministry of Health and Family Welfare published a draft notification on 28 June 2026 proposing to amend the Medical Devices Rules, 2017 to cut timelines for manufacturing licences, including from 140 to 115 days for Class B devices.
Summary
The Ministry of Health and Family Welfare published a draft notification in the Official Gazette, announced on 28 June 2026, proposing amendments to the Medical Devices Rules, 2017 to simplify and speed up licensing of medical devices. The Rules classify devices into four risk-based classes, A, B, C and D, with Class D the highest risk. The draft proposes cutting the timeline for a manufacturing licence for Class B devices, such as blood pressure monitors, hypodermic needles and pulse oximeters, from 140 to 115 days, and for Class C and D devices, such as cardiac stents and hip and knee implants, from 105 to 90 days. The draft also sets timelines for each stage, including scrutiny, audit by notified bodies, compliance verification and issue of licence.
Key facts
- Rules
- Medical Devices Rules, 2017 (draft amendment)
- Risk classes
- A, B, C, D; Class D highest risk
- Class B licence
- 140 days to 115 days
- Class C and D licence
- 105 days to 90 days
- Also
- Stage-wise timelines: scrutiny, notified-body audit, verification, issue
Practice MCQs 3 questions
Under the Medical Devices Rules, 2017, which class comprises the highest-risk medical devices?
Show answer
Correct answer: D — Class D
Medical devices are classified into four risk-based categories, Class A, B, C and D, with Class D comprising the highest-risk devices.
The June 2026 draft amendment to the Medical Devices Rules, 2017 proposes to change the manufacturing licence timeline for Class B devices from:
Show answer
Correct answer: C — 140 days to 115 days
For Class B devices, such as blood pressure monitors and pulse oximeters, the timeline is proposed to be cut from 140 to 115 days.
For high-risk Class C and Class D medical devices such as cardiac stents, the June 2026 draft proposes to cut the manufacturing licence timeline from:
Show answer
Correct answer: A — 105 days to 90 days
For Class C and D devices, including cardiac stents and hip and knee implants, the timeline is proposed to be reduced from 105 to 90 days.