VOICE OF PHARMA · MEDICAL DEVICES REGULATORY MODULE · v1.0.0

Medical Devices Rules, 2017 & Current Position

Source-first regulatory database with permanent Gazette history.

Informational use only. Verify every automatic mapping against the signed Gazette before regulatory reliance.
schedule · SCH-2

SECOND SCHEDULE — [Refer rules 13(5), 13(7), 20(2), 21(2), 25(3), 29(1), 31(1), 34(2), 34(4), 35(2), 37,40(2), 42(1), 51(2), 59(2), 63(1), 64(1), 81(1), 84, 27[87A(3), 87C(1) and] 91]

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schedule · SCH-3

THIRD SCHEDULE — [Refer rules 13(5), 13(9), 14,15, 20(4), 20(6)] DOCUMENTS REQUIRED FOR REGISTRATION OF NOTIFIED BODY, ITS DUTIES AND FUNCTIONS

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schedule · SCH-4

FOURTH SCHEDULE — [Refer rules 20(2), 21(2), 34(2), 34(4), 63(1) and 64(1)] DOCUMENTS REQUIRED FOR GRANT OF LICENCE TO MANUFACTURE FOR SALE OR FOR DISTRIBUTION OR IMPORT

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schedule · SCH-5

FIFTH SCHEDULE — [Refer rules 20(3), 20(5), 20(8), 22(i)] QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES

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schedule · SCH-6

SIXTH SCHEDULE — [Refer rules 26(iii), 26(iv), 38(v) and 38(vii)] POST APPROVAL CHANGE (A) Changes in respect of following shall be considered as major change

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schedule · SCH-7

SEVENTH SCHEDULE — [Refer rules 51(1), 51(2), 53(H), 53(v), 59(3)] REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE FOR CONDUCTING CLINICAL INVESTIGATION

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Complete Gazette change chain

Date pending verification Automatic Informational

83b46c914a8bd0aa129a — Medical Devices Rules, 2017

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2018-08-01 Final In Force

G.S.R. 729(E) / 2018-08-01 — Medical Devices (Amendment) Rules, 2018 — performance evaluation report for IVDs

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2019-01-15 Final In Force

G.S.R. 30(E) / 2019-01-15 — Medical Devices (Amendment) Rules, 2019 — electronic instructions for use

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2019-03-18 Final In Force

G.S.R. 224(E) / 2019-03-18 — Medical Devices (Second Amendment) Rules, 2019 — environmental requirements

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2019-04-18 Final In Force

G.S.R. 318(E) / 2019-04-18 — Medical Devices amendment — free sale certificate fees

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2019-09-13 Final In Force

G.S.R. 652(E) / 2019-09-13 — Medical Devices amendment — Form MD-10 issuing authority

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2019-10-18 Final In Force

G.S.R. 797(E) / 2019-10-18 — Medical Devices amendment — registration of certain medical devices

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2020-02-11 Final In Force

G.S.R. 102(E) / 2020-02-11 — Medical Devices (Amendment) Rules, 2020 — registration provisions

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2021-12-31 Final In Force

G.S.R. 918(E) / 2021-12-31 — Medical Devices amendment — Unique Device Identification

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2022-01-18 Final In Force

G.S.R. 19(E) / 2022-01-18 — Medical Devices amendment — rules 19B to 19E

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2022-03-04 Final In Force

G.S.R. 174(E) / 2022-03-04 — Medical Devices amendment — inclusion of United Kingdom

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2022-05-18 Final In Force

G.S.R. 356(E) / 2022-05-18 — Medical Devices amendment — suspension and cancellation of import licence

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2022-06-15 Final In Force

G.S.R. 450(E) / 2022-06-15 — Medical Devices amendment — TSE/BSE certificate

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2022-09-30 Final In Force

G.S.R. 754(E) / 2022-09-30 — Medical Devices (Fifth Amendment) Rules, 2022 — registration of sale premises

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2022-10-14 Final In Force

G.S.R. 777(E) / 2022-10-14 — Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

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2023-06-02 Final In Force

G.S.R. 409(E) / 2023-06-02 — Medical Devices (Amendment) Rules, 2023 — State Medical Devices Testing Laboratories

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2026-03-02 Final In Force

G.S.R. 165(E) / 2026-03-02 — Medical Devices amendment — qualifications of Inspector Medical Devices and Government Analyst

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2026-04-10 Draft Not Current Law

G.S.R. 269(E) / 2026-04-10 — Draft amendment — medical device testing fees

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2026-04-10 Draft Not Current Law

G.S.R. 270(E) / 2026-04-10 — Draft amendment — recognition of European Union countries

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2026-06-23 Draft Not Current Law

G.S.R. 515(E) / 2026-06-23 — Draft amendment under Medical Devices Rules, 2017

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2026-08-14 Final In Force

G.S.R. 743(E) / 2026-08-14 — Medical Devices amendment — Ninth Schedule and labelling for sterilization activities

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2026-08-14 Final In Force

G.S.R. 744(E) / 2026-08-14 — Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

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