By Andalib Akhter
New Delhi
In a move aimed at strengthening India’s medical devices sector and improving the ease of doing business, the Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017 to significantly reduce the time required for granting manufacturing licences across several categories of medical devices.
The draft notification, published in the Official Gazette, seeks to simplify and expedite the regulatory approval process while maintaining existing standards of quality, safety and performance. The proposed changes are expected to improve regulatory efficiency, support domestic manufacturing and ensure quicker availability of quality medical devices in the Indian market.
Under the existing Medical Devices Rules, medical devices are classified into four risk-based categories—Class A, B, C and D—with Class D representing the highest-risk products. The amendments focus primarily on reducing approval timelines for manufacturing licences for Class B, C and D devices.
For Class B medical devices, which include low- to moderate-risk products such as blood pressure monitors, hypodermic needles and pulse oximeters, the proposed licensing period will be reduced from 140 days to 115 days.
For Class C and Class D devices, which include high-risk products such as cardiac stents, hip and knee implants and other orthopaedic implants, the government has proposed reducing the approval timeline from 105 days to 90 days.
In addition to shorter approval periods, the draft amendments introduce clearly defined timelines for every stage of the licensing process, including application scrutiny, audits by notified bodies, compliance verification and issuance of licences. The Ministry said the changes are intended to make the regulatory framework more transparent, predictable and efficient.
Industry experts believe the proposed reforms could help accelerate investment in India’s rapidly growing medical devices sector by reducing regulatory delays without compromising product quality or patient safety. Faster approvals are also expected to improve access to advanced medical technologies for hospitals and patients while supporting the government’s vision of strengthening domestic manufacturing under the ‘Make in India’ initiative.
The Ministry has placed the draft notification in the public domain and invited comments and suggestions from industry stakeholders, manufacturers, healthcare professionals and the public. The draft is available in the Official Gazette and on the website of the Central Drugs Standard Control Organisation (CDSCO), with stakeholders requested to submit their feedback within the prescribed consultation period before the amendments are finalised.