Draft amendments to Medical Devices Rules, 2017 to cut licensing time
Next story · 28 JunBackgrounder: DIKSHA, the national digital school platform
The Health Ministry published draft amendments to the Medical Devices Rules, 2017 on 28 June 2026 to speed up manufacturing licences. Class B devices such as BP monitors would get licences in 115 days instead of 140, and Class C and D devices such as cardiac stents in 90 days instead of 105, with stage-wise timelines.
- Release
- 28 Jun 2026, Ministry of Health and Family Welfare
- Rules
- Medical Devices Rules, 2017; draft Gazette notification
- Risk classes
- A, B, C, D; Class D is highest risk
- Class B
- 140 days to 115 days
- Class C and D
- 105 days to 90 days
- Comments
- open to stakeholders; draft on CDSCO website
The Medical Devices Rules draft: what happened?
Every medical device sold in India needs a licence, and the riskier the device, the closer the check. Long approval times slow down makers and delay new devices for patients. The draft shortens the wait without lowering the quality bar.
- Timelines would be fixed for each stage: scrutiny, notified-body audit, compliance check and licence issue.
- The aim is ease of doing business and faster access to quality devices.
- The draft is open for public comments.
Which devices fall in which class?
- Class B: low to moderate risk, such as blood pressure monitors, hypodermic needles and pulse oximeters.
- Class C and D: high risk, such as cardiac stents, hip and knee implants and other orthopaedic implants.
Why does the Medical Devices Rules draft matter?
- Industry: Predictable, shorter approvals for device makers.
- Patients: Quicker access to quality-assured devices.
What can Prelims ask on the Medical Devices Rules draft?
- Medical Devices Rules, 2017: four risk classes A to D; D highest risk.
- Draft: Class B licence 140 to 115 days; Class C and D 105 to 90 days.
- Regulator website: CDSCO.
How to use this in Mains
- As per PIB (2026-06-28): the Health Ministry published draft amendments to the Medical Devices Rules, 2017 to rationalise timelines for manufacturing licences across risk categories.
- The test is to make business easier without lowering safety.
Quotable data pointThe Health Ministry published draft amendments to the Medical Devices Rules, 2017 to rationalise timelines for manufacturing licences across risk categories.
PIB: Health: Medical Devices Rules draft, 28 Jun 2026
Exam angle
Prelims: regulator for medical devices.
Practice MCQs
Original practice questions (not PYQs).
Under the Medical Devices Rules, 2017, which class has the highest-risk devices?
Answer (d) & explanation
PIB (Health), 28 Jun 2026.
Questions students ask about this
What do the draft amendments change?
They shorten the timelines for grant of manufacturing licences for medical devices and fix timelines for each stage of the process.
How are medical devices classified?
Into four risk-based classes, A, B, C and D, with Class D the highest risk.
What is the new proposed timeline for Class B devices?
115 days instead of 140 days.
Keep studying
Go deeper
Official source: PIB: Health: Medical Devices Rules draft, 28 Jun 2026
facts from cited sources only; faculty review pending