Medical Device Regulatory – VoP-Voice of Pharma

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.

Classification and Grouping

3 provisions

Rule 4 — Classification of medical devices

Medical Devices Rules, Rule 4

Official rule source →

Rule 5 — Medical device grouping

Medical Devices Rules, Rule 5

Official rule source →

FIRST SCHEDULE — [Refer rule 4] PARAMETERS FOR CLASSIFICATION OF MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES

FIRST SCHEDULE

Official rule source →

Manufacturing Licence and QMS

7 provisions

Rule 20 — Application for manufacture for sale or for distribution of Class A

Medical Devices Rules, Rule 20

Official rule source →

Rule 21 — Application for manufacturing Class C or Class D devices

Medical Devices Rules, Rule 21

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Rule 22 — Requirements for grant of manufacturing licence or loan licence

Medical Devices Rules, Rule 22

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Rule 25 — Grant of licence or loan licence to manufacture for sale or for

Medical Devices Rules, Rule 25

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Rule 26 — Conditions for manufacturing licence or loan licence

Medical Devices Rules, Rule 26

Official rule source →

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

FOURTH SCHEDULE

Gazette change chain · 2

2019-01-15 · Medical Devices (Amendment) Rules, 2019 — electronic instructions for use

2022-06-15 · Medical Devices amendment — TSE/BSE certificate

Official rule source →

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

FIFTH SCHEDULE

Gazette change chain · 1

2019-03-18 · Medical Devices (Second Amendment) Rules, 2019 — environmental requirements

Official rule source →

Import and Registration

4 provisions

Rule 34 — Application for grant of import licence

Medical Devices Rules, Rule 34

Official rule source →

Rule 35 — Inspection of overseas manufacturing site

Medical Devices Rules, Rule 35

Official rule source →

Rule 36 — Grant of import licence

Medical Devices Rules, Rule 36

Gazette change chain · 1

2022-03-04 · Medical Devices amendment — inclusion of United Kingdom

Official rule source →

Rule 38 — Conditions to be complied with by licence holder

Medical Devices Rules, Rule 38

Official rule source →

Class A Non-Sterile/Non-Measuring

7 provisions

Rule 19G — Application of this Chapter.― (1) This Chapter shall be applicable to

Medical Devices Rules, Rule 19G

Gazette change chain · 2

2022-10-14 · Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

2026-08-14 · Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

Official rule source →

Rule 19H — Uploading of information for registration.― (1) The manufacturer of

Medical Devices Rules, Rule 19H

Gazette change chain · 2

2022-10-14 · Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

2026-08-14 · Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

Official rule source →

Rule 19I — Registration number.― The registration number for a Class A non-

Medical Devices Rules, Rule 19I

Gazette change chain · 2

2022-10-14 · Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

2026-08-14 · Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

Official rule source →

Rule 19J — Import of Class A non-sterile and non-measuring medical

Medical Devices Rules, Rule 19J

Gazette change chain · 2

2022-10-14 · Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

2026-08-14 · Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

Official rule source →

Rule 19K — Registration number for import.― The registration number for

Medical Devices Rules, Rule 19K

Gazette change chain · 2

2022-10-14 · Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

2026-08-14 · Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

Official rule source →

Rule 19L — Maintenance of records.― (1) The manufacturer or, as the case

Medical Devices Rules, Rule 19L

Gazette change chain · 2

2022-10-14 · Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

2026-08-14 · Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

Official rule source →

Rule 19M — Cancellation or suspension of registration.― (1) The State

Medical Devices Rules, Rule 19M

Gazette change chain · 2

2022-10-14 · Medical Devices (Sixth Amendment) Rules, 2022 — Class A non-sterile non-measuring devices

2026-08-14 · Medical Devices amendment — EU countries in rule 63 and QMS for Class A NSNM devices

Official rule source →

Labelling, UDI and Sterilization

4 provisions

Rule 44 — Labelling of medical devices

Medical Devices Rules, Rule 44

Gazette change chain · 1

2026-08-14 · Medical Devices amendment — Ninth Schedule and labelling for sterilization activities

Official rule source →

Rule 45 — Exemption of labelling requirements for export of medical devices

Medical Devices Rules, Rule 45

Official rule source →

Rule 47 — Shelf life of medical devices

Medical Devices Rules, Rule 47

Official rule source →

NINTH SCHEDULE — Sterilization activities and prescribed requirements (inserted by G.S.R. 743(E), 14 August 2026)

NINTH SCHEDULE

Gazette change chain · 1

2026-08-14 · Medical Devices amendment — Ninth Schedule and labelling for sterilization activities

Official rule source →

Clinical Investigation and IVD Performance

6 provisions

Rule 49 — Conduct of clinical investigation

Medical Devices Rules, Rule 49

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Rule 51 — Application for grant of permission to conduct clinical investigation

Medical Devices Rules, Rule 51

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Rule 52 — Permission to conduct clinical investigation

Medical Devices Rules, Rule 52

Official rule source →

Rule 59 — Permission to conduct clinical performance evaluation for new in

Medical Devices Rules, Rule 59

Gazette change chain · 1

2019-01-15 · Medical Devices (Amendment) Rules, 2019 — electronic instructions for use

Official rule source →

Rule 60 — Conditions for permission to conduct of clinical performance

Medical Devices Rules, Rule 60

Official rule source →

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

SEVENTH SCHEDULE

Gazette change chain · 1

2019-01-15 · Medical Devices (Amendment) Rules, 2019 — electronic instructions for use

Official rule source →

Sale Premises Registration

3 provisions

Rule 87B — Conditions of registration certificate to sell, stock, exhibit or offer

Medical Devices Rules, Rule 87B

Gazette change chain · 1

2022-09-30 · Medical Devices (Fifth Amendment) Rules, 2022 — registration of sale premises

Official rule source →

Rule 87C — Validity of registration certificate.— (1) A registration certificate

Medical Devices Rules, Rule 87C

Gazette change chain · 1

2022-09-30 · Medical Devices (Fifth Amendment) Rules, 2022 — registration of sale premises

Official rule source →

Rule 87D — Suspension and cancellation of Registration Certificate.— (1) Where

Medical Devices Rules, Rule 87D

Gazette change chain · 1

2022-09-30 · Medical Devices (Fifth Amendment) Rules, 2022 — registration of sale premises

Official rule source →

Testing Laboratories and Enforcement

5 provisions

Rule 18 — Medical Device Testing Officer and Medical Device Officer

Medical Devices Rules, Rule 18

Gazette change chain · 2

2023-06-02 · Medical Devices (Amendment) Rules, 2023 — State Medical Devices Testing Laboratories

2026-03-02 · Medical Devices amendment — qualifications of Inspector Medical Devices and Government Analyst

Official rule source →

Rule 19 — Central medical device testing laboratory

Medical Devices Rules, Rule 19

Gazette change chain · 1

2023-06-02 · Medical Devices (Amendment) Rules, 2023 — State Medical Devices Testing Laboratories

Official rule source →

Rule 83 — Registration of medical device testing laboratory

Medical Devices Rules, Rule 83

Official rule source →

Rule 84 — Validity of registration

Medical Devices Rules, Rule 84

Official rule source →

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]

SECOND SCHEDULE

Gazette change chain · 4

2018-08-01 · Medical Devices (Amendment) Rules, 2018 — performance evaluation report for IVDs

2019-04-18 · Medical Devices amendment — free sale certificate fees

2026-03-02 · Medical Devices amendment — qualifications of Inspector Medical Devices and Government Analyst

2026-04-10 · Draft amendment — medical device testing fees

Official rule source →