India’s Ministry of Health and Family Welfare published a draft notification in its Official Gazette (G.S.R. 515(E), dated June 23, 2026) proposing amendments to the Medical Devices Rules, 2017 that will shorten manufacturing license timelines while preserving the country’s quality, safety, and performance requirements. In announcing the draft, the ministry said the changes are meant to improve the ease of doing business and speed the availability of quality-assured devices.
By the ministry’s own accounting, the net effect is a faster clock in each risk tier:
- For Class B devices — low- to moderate-risk products such as blood pressure monitors, hypodermic needles, and pulse oximeters — the timeline for grant of a manufacturing license would fall from 140 days to 115.
- For higher-risk Class C and Class D devices, which include cardiac stents and hip and knee implants, it would drop from 105 days to 90. (The higher-risk tier finishing ahead of Class B is not a quirk: Class C and D devices already ran on a shorter baseline, 105 versus 140 days, under the existing rules, so both tiers move down in parallel.)
Those headline figures are the sum of a series of granular, stage-by-stage changes in the gazette text. For Class B devices, licensed by State Licensing Authorities under Rule 20, the state authority would have to complete its scrutiny of an application and assign it to a notified body within 30 days of online submission. The notified body’s site audit would then have to be completed within 30 days of that assignment, and the body would have to furnish its final report and recommendations within 15 days of finishing the audit. In cases where the audit surfaces gaps in a manufacturer’s quality management system, a compliance verification step would be capped at 20 days from receipt of the manufacturer’s response.
For Class C and Class D devices, licensed centrally under Rule 23, the draft trims one inspection timeline from 60 days to 55 and adds a new 15-day window for verifying compliance when quality system nonconformities arise during inspection. Two further timelines elsewhere in the rules are shortened, from 45 days to 30 and from 45 days to 20. The draft also builds in a “deficiency clock” that restarts only once a manufacturer clears identified shortcomings — a change meant to make the countdown more predictable for regulators and industry alike.
