India medical device regulations

Collection of acts and rules related to medical device regulation including amendments and notifications.

G.S.R. 409(E) of 2 June 2023 amends rules 18 and 19 to provide for State Medical Device Testing Laboratories, State Medical Device Testing Officers, and enforcement powers of State authorities. This amendment post-dates CDSCO’s February 2023 consolidated text and is captured only in the separate amending expression. Official gazette PDF ingested as corpus text.

G.S.R. 777(E) of 14 October 2022 inserts Chapter III-B (rules 19G–19M) exempting non-sterile and non-measuring Class A medical devices from the licensing regime via a registration route on the online portal. This is the last amendment reflected in CDSCO’s February 2023 consolidated text. Official gazette PDF ingested as corpus text.

G.S.R. 754(E) of 30 September 2022 regulates the sale of medical devices by requiring registration of premises (rules 87A–87D family), including registration certificates to sell, stock, exhibit or offer for sale or distribute medical devices. Official gazette PDF ingested as corpus text.

G.S.R. 450(E) of 15 June 2022 amends the Fourth Schedule so that a certificate concerning transmissible spongiform encephalopathy (TSE) or bovine spongiform encephalopathy (BSE) free material is accepted where animal-derived material is used. Official gazette PDF ingested as corpus text.

G.S.R. 356(E) of 18 May 2022 inserts rule 43A on suspension and cancellation of licences by the Central Licensing Authority for non-compliance with the Act or the rules. Official gazette PDF ingested as corpus text.

G.S.R. 174(E) of 4 March 2022 amends rule 36(3) to include auditing organisations of the United Kingdom among those whose audits of medical device manufacturers outside India are accepted. Official gazette PDF ingested as corpus text.

G.S.R. 19(E) of 18 January 2022 amends rules 19B–19E on loan licensing and related procedures. Note: the ordinal in the short title is recorded as "(First Amendment)" by inference — the ordinal glyph is unreadable in the official scan under both pdf-parse and pdftotext extraction, while the amendment substance (rules 19B–19E) is unambiguous. Official gazette PDF ingested as corpus text.

G.S.R. 918(E) of 31 December 2021 amends rule 46 to require unique device identification of medical devices, with UDI-DI to be declared on labels in a phased manner. Official gazette PDF ingested as corpus text.

Requirements for registration and import licenses for medical devices. Foreign manufacturers must appoint an authorized Indian agent.

G.S.R. 102(E) of 11 February 2020, in force 1 April 2020, inserts Chapter III-A (rules 19A–19F) mandating registration of medical devices marketed in India before the rules came into force, on an online registration portal with a nominal fee. Official gazette PDF ingested as corpus text.

SUGAM is the online portal for medical device applications including registration, import licenses, and manufacturing approvals. All applications must be submitted online.

G.S.R. 787(E) of 16 October 2019 exempts State and Central Government medical device testing laboratories from NABL accreditation for a period of two years, amending the rules on recognition of testing laboratories. Official gazette PDF ingested as corpus text.

G.S.R. 652(E) of 13 September 2019 amends Form MD-10 (loan licence to manufacture) so the issuing authority is the Central Licensing Authority instead of the State Licensing Authority. Official gazette PDF ingested as corpus text.

G.S.R. 318(E) of 18 April 2019 amends rule 91 (export of medical devices) and the Second Schedule fee table to introduce fees for free sale certificates. Official gazette PDF ingested as corpus text.

G.S.R. 224(E) of 18 March 2019 amends the environmental requirements for manufacturing premises in Annexure A of the Fifth Schedule (conditions of licence to manufacture). Official gazette PDF ingested as corpus text.

G.S.R. 30(E) of 15 January 2019 permits electronic instructions for use (e-IFU) for specified medical devices, amending rule 3 (definitions), rule 59 (information supplied with the device), and the Fourth and Seventh Schedules. The closing note records the rules as last amended by G.S.R. 729(E). Official gazette PDF ingested as corpus text.

G.S.R. 729(E) of 1 August 2018, the first amendment to the Medical Devices Rules, 2017. Inserts the requirement that an application for import or manufacture of an in-vitro diagnostic medical device be accompanied by a performance evaluation report as specified in the Fourth Schedule. Official gazette PDF ingested as corpus text.

G.S.R. 78(E) Medical Devices Rules, 2017 as published by CDSCO. Ingested Chapters I–XII, Rules 1–97, First–Eighth Schedule, and Forms MD-1–MD-40 from the official PDF. This expression is the 31 January 2017 gazette text; later GSR amendments are not in this file.

CDSCO’s official consolidated text of the Medical Devices Rules, 2017 published February 2023, current only through G.S.R. 777(E) (14 October 2022) — still the newest consolidated edition on CDSCO’s Medical Devices Rules page as of 29 August 2026 (re-fetched byte-identical; no consolidated edition after it exists, only per-amendment notifications): Chapters I–XII including inserted Chapters III-A and III-B, rules 1–97 with 19A–19M/43A/87B–87D, Schedules 1–8, and Forms MD-1–MD-40, all ingested as corpus text. Currency caveat: G.S.R. 409(E) (2 June 2023) is not reflected in this file — read it together with the in-gsr-409e-2023 row, or use the per-amendment rows for the current statute. December 2025 draft amendments remain draft.

CDSCO regulates medical devices in India under the Ministry of Health and Family Welfare. Covers device registration, import licenses, and manufacturing approvals.

India uses GHTF-aligned classification: Class A (low risk), Class B (low-moderate), Class C (moderate-high), Class D (high risk). Classification determines registration pathway.