Medical Device Licensing Timelines In India To Shorten Under Proposed Amendments
By Gunjan Bagla, Amritt Inc.
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)¹ 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 115.²
- 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.
Where Class A Sits
The lowest-risk tier, Class A, sits largely outside this licensing machinery. Since a 2020 amendment, Class A non-sterile, non-measuring devices are handled through simplified self-registration on CDSCO’s online Sugam portal rather than a full manufacturing license, though sterile or measuring Class A products still require one. Even so, “low risk” does not mean unregulated: every Class A device must be registered before it can be legally manufactured, imported, or sold in India.
How It Compares To The FDA And The EU
For readers familiar with the U.S. or European regulatory systems,3,4 the following comparison provides useful context for understanding India's medical device regulatory framework.
India classifies medical devices into four risk classes (A–D) following the former Global Harmonization Task Force (GHTF) risk classification framework, whereas the U.S. FDA uses three classes (I–III). Although both systems are risk-based, the classifications are not directly equivalent.³,⁴
The FDA clears many moderate-risk Class II devices through the 510(k) pathway, with an MDUFA performance goal of reaching a decision within 90 FDA Days.* In contrast, most high-risk Class III devices require premarket approval (PMA), a substantially more rigorous review process that typically takes many months, with total elapsed review time often exceeding the FDA's review goals once sponsor response periods are included.
The European Union does not operate a centralized medical device approval system. Instead, manufacturers obtain a CE mark through a conformity assessment conducted by independent government-designated notified bodies under the Medical Device Regulation (EU) 2017/745. The European Medicines Agency (EMA) has a limited consultative role in specific areas, including certain drug-device combinations and companion diagnostics.
Against that backdrop, India's use of statutory review timelines may provide greater procedural predictability than the European Union's system, where certification timelines can vary considerably depending on the capacity and workload of individual notified bodies.
For companies evaluating global regulatory pathways, these differences suggest that India's increasingly structured review process may offer a more predictable regulatory environment than the European Union, while remaining broadly aligned with internationally recognized risk-based classification principles.
* The U.S. FDA's review performance goals are measured in FDA Days, which count only the time during which the FDA is actively reviewing a submission. Time spent by the manufacturer in preparing responses to FDA requests for additional information is excluded, so that total elapsed calendar time can be substantially longer than the published FDA Day goal.
From Drugs To A Device Framework
The timelines are a relatively recent construct. Before the 2017 rules took effect in 2018, India had no dedicated medical device framework; devices were regulated as drugs under the Drugs and Cosmetics Act, 1940 — colonial era legislation never designed for them. Only a short “notified” list of device categories faced mandatory oversight. The 2017 rules, broadened by 2020 amendments, introduced risk-based classification and progressively pulled all devices under CDSCO regulation, with Class C and D products required to hold licenses by October 2023.
A Wider Streamlining Agenda
The proposal fits a broader regulatory-reform push. Under the “Minimum Government, Maximum Governance” banner, New Delhi has pursued successive reforms that decriminalize minor technical compliance lapses — including under the Drugs and Cosmetics Act — by replacing imprisonment with civil penalties. The latest iteration, passed in April 2026, rationalized more than 1,000 offenses across 79 central acts spanning 23 ministries.
The draft was open for stakeholder comment for 30 days from publication, with objections addressed to the Under Secretary (Drugs) at the Ministry of Health and Family Welfare. It is available in the Official Gazette and on the CDSCO website. I expect the final rules to be substantially unaltered, given past history.
References
- Ministry of Health and Family Welfare, draft notification G.S.R. 515(E), Medical Devices (Amendment) Rules, 2026, The Gazette of India, June 23–24, 2026. In Hindi followed by English egazette.gov.in/WriteReadData/2026/273896.pdf
- Press Information Bureau, “Union Ministry of Health and Family Welfare Proposes Amendments to Medical Devices Rules, 2017 to Streamline Licensing Process,” Release ID 2278555, June 28, 2026. pib.gov.in — Release 2278555
- European Medicines Agency, “Medical devices” — role of Notified Bodies, CE marking, and EMA’s consultation role. ema.europa.eu — Medical devices
- U.S. Food and Drug Administration, MDUFA V Performance Goals and Procedures, FYs 2023–2027 (510(k) and PMA total-time-to-decision goals). fda.gov (MDUFA V performance goals)
About The Author
Based in Los Angeles, Gunjan Bagla is managing director of Amritt Inc., a California-based consulting firm focused on helping American companies to succeed in India. His clients include Covidien, Roche Diagnostics, BD, Nordic Naturals, Johnson & Johnson, Gojo, and many more. Gunjan spoke three times at the MD&M West Conference in Anaheim, and was on the keynote panels at MEDevice San Diego and IMDI in Ahmedabad, India.
For his India expertise, he has appeared in The New York Times, the Los Angeles Times, and the Washington Post, and on Bloomberg TV, BBC Television, and Fox Business News. He also writes about India for the Harvard Business Review and the Huffington Post. Gunjan has an MBA from Southern Illinois University and a mechanical engineering degree from the Indian Institute of Technology (IIT) Kanpur in India.