Medical Devices – Notifications

Last Updated on November 21, 2024 by The Health Master

Govt of India Gazette of India Notification
Gazette of India

Download the Notifications – Medical Devices

The Government of India issues notifications from time to time, which are published by the Department of Publication and printed regularly by the Government of India Printing Presses.

We have provided some of the notifications relevant to the above-said topic, Click on the below links for more information:

2023

GSR No. 409(E) dt 02-06-2023 Amendment of Rule 18 & 19 for Medical Devices Testing Laboratory – Medical Devices (Amendment) Rules, 2023

GSR 157(E) dt 01-03-2023 Draft Medical Device Rule 2023- State Medical Device Testing Laboratory

2022

GSR 777(E) dt 14-10-2022 Registration of Class A Medical Devices Medical Devices (Sixth Amendment) Rules, 2022

GSR 754(E) dt 30-09-2022 Sale of medical device by means of retail and wholesale

S.O. 4574(E) dt 28-09-2022 Designation of Government Analysts at RDTL Chandigarh as MDTO as per MDR 2017

S.O. 4573(E) dt 28-09-2022 Notification for designation of RDTL Chandigarh also as CMDTL as per MDR 2017

GSR 710(E) dt 20-09-2022 Draft notification Exemption of certain Class A medical devices from licensing regime

S.O. 3758(E) dt 10-08-2022 To authorize director incharge Dr. Saroj Kumar Ghosh of CDL Kolkata for signing report of test of MD samples sent by Court of Laws.

S.O.-3758E-dt-10-08-2022-To-authorize-director-incharge-Dr.-Saroj-Kumar-Ghosh-of-CDL-Kolkata-for-signing-report-of-test-of-MD-samples-sent-by-Court-of-Laws.

S.O. 3739(E) dt 02-08-2022 Notification of Medical Devices Testing Officer for CMDTL

S.O.-3739E-dt-02-08-2022-Notification-of-Medical-Devices-Testing-Officer-for-CMDTL

Ministry of Health Dt 08-07-2022 Draft of New Drugs, Medical Devices, and Cosmetics Bill 2022

Ministry-of-Health-Dt-08-07-2022-Draft-of-New-Drugs-Medical-Devices-and-Cosmetics-Bill-2022

GSR 450(E) dt 15-06-2022 Final notification to amend Fourth Schedule wrt TSE or BSE certificate under MDR

GSR No. 356 (E) Dt 18-05-2022 Inserted rule 43A for Suspension and cancellation of license in MDR 2017

GSR 228(E) dt 29-03-2022 To amend Fourth Schedule wrt TSE or BSE certificate under MDR

GSR 174(E) dt 04-03-2022 Amendment of Rule 36(3) MDR to include United Kingdom under MDR 2017

GSR 104(E) dt 09-02-2022 Draft notification to amend Medical Devices Rules 2017 – regarding Rule 34, 87, insertion of Form MD 41, 42, 43

GSR No. 23(E) dt 18-01-2022 Draft Notification – Rule 43 – Suspension and cancellation of license of Medical Devices

GSR No. 19(E) dt 18-01-2022 – Draft notificationRegistration number for Medical Devices – Medical Devices Rules, 2017

2021

GSR 918(E) dt 31-12-2021 Medical Device (Amendment) Rules 2021Unique device identification of medical device

GSR 850(E) dt 10-12-2021 Draft Amendment of Rule 36(3) MDR to include United Kingdom

DCGI dt 10-12-2021 List of the certified 18 Medical Device Testing Laboratory under MDR 2017

DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017

GSR 729(E) dt 12-10-2021 – Draft of Medical Devices (Amendment) Rules 2021 ISO 13485

S.O. 3596 dt 02-09-2021 – Notification of Amar Jyoti, Dilip Sarkar, Rinku Kalita & Arun Kr Das as MDTO

NPPA Office Memorandum 03-08-2021 – Submission of price related information for Knee Implants

NPPA-Office-Memorandum-03-08-2021-Submission-of-price-related-information-for-Knee-Implants.

NPPA Office Memorandum dt 23-07-2021 – for Revised MRPs in pursuance to the TMR Notification for 5 Medical Devices

NPPA-Office-Memorandum-dt-23-07-2021-–-for-Revised-MRPs-in-pursuance-to-the-TMR-Notification-for-5-Medical-Devices

NPPA S.O. 2808 dt 13-07-2021 – Trade Margin Rationalisation (TMR) of 5 Medical Devices

NPPA-S.O.-2808-dt-13-07-2021-Trade-Margin-Rationalisation-TMR-of-5-Medical-Devices

NPPA Dt 09-06-2021 – Office Memorandum -Revised MRP for Oxygen Concentrators

NPPA-Dt-09-06-2021-Office-Memorandum-Revised-MRP-for-Oxygen-Concentrators

NPPA Office Memorandum dt 04-06-2021 In pursuance to the Notification dated 03.06.2021 for Oxygen Concentrators

NPPA-Office-Memorandum-dt-04-06-2021-In-pursuance-to-the-Notification-dated-03.06.2021-for-Oxygen-Concentrators

NPPA order dt 03-06-2021 Price Cap for Oxygen Concentrator through Trade Margin Rationalisation Approach

NPPA-order-dt-03-06-2021-Price-Cap-for-Oxygen-Concentrator-through-Trade-Margin-Rationalisation-Approach

NPPA Office Memorandum dt 15-05-2021 for call of MRP Data for Pulse Oximeter & Oxygen Concentrator 2021

NPPA-Office-Memorandum-dt-15-05-2021-for-call-of-MRP-Data-for-Pulse-Oximeter-Oxygen-Concentrator-2021

GSR 98(E) 05-02-2021 – Draft notification – American Standard Test Method (ASTM) in the product standards for Medical Devices under Rule 7 of MDR-2017

2020

NPPA has notified vide S.O.-No.-1232(E) dt-31-03-2020 All Medical devices will be governed under DPCO w.e.f. 01-04-2020

G.S.R.-102E-dt-11-02-2020-Medical-Devices-Amendment-Rules-2020

S.O.-648E-dt-11-02-2020-Medical-Device-Definition-Instruments-apparatus-etc-are-drugs

2019

S.O.-No.-4672-E-dt-27-12-2019-Devices-for-human-use-date-extended-CT-Scan-MRI-X-Ray-etc.

S.O.-No.-4671-E-dt.-27-12-2019-Devices-for-human-use-date-extended-Nebulizer-BP-Apparatus-Thermometer-Glucometer

S.O.-NO.-3721E-dt.-16-10-2019-Notification-Ultrasound-equipment-as-drug-w.e.f.-01-11-2020

G.S.R-No.-787E-dt.-16-10-2019-MDR-Govt.-Testing-Labs-exempted-for-accraditation-from-NABL-for-two-years

G.S.R. 797(E) dt. 18-10-19 Draft Notification-MDR-2019

G.-S.-R.-652-E-dt.-13-09-2019-Medical-Devices-Fourth-Amendment-Rules-2019

G.S.R.-No.-499E-dt.-17-07-2019-Medical-Devices

G.-S.-R.-318-E-dt.-18-04-2019-Medical-Devices-Third-Amendment-Rules-2019

G.-S.-R.-224-E-dt.-18-03-2019-Medical-Devices-Second-Amendment-Rules-2019

S.-O.-775-E-dt.-08-02-2019-Devices-declared-drug-Nebulizer-BP-Apparatus-Thermometer-Glucometer

G.-S.-R.-30-E-dt.-15-01-2019-Medical-Devices-Amendment-Rules-2019

2018

S.-O.-5980-E-dt.-03-12-2018-Medical-Devices-for-human-use-declared-as-Drug Nebulizer, Blood Pressure Monitoring Devices, Digital Thermometer and Glucometer.

G.S.R.-1074-E-dt.-30-10-2018-Section-10A-Prohibited-Rapid-Diagnostic-Tests-for-diagnosis-of-malaria

G.-S.-R.-729-E-dt.-01-08-2018-Medical-Devices-Amendment-Rules-2018

S.O.-3400-E-dt.-11-07-18-Medical-devices-MDTO

S.-O.-2237-E-dt.-01-06-2018-Designated-Central-Medical-Device-Testing-Laboratory: As Appellate Laboratory

S.O-1352-E-dt.-23-03-18-Section-26A-Banned-Malaria-Rapid-test-kits

2017

G.S.R-78-E-dt.-31-01-17-Medical-Device-Rules-2017

2005

S.O 1468 dt. 06-10-2005 List of 10 sterile devices intended for external or internal use in human beings as drugs


Procedure to obtain license for manufacturing of Medical Devices

Procedure for registration of Medical Devices: CDSCO

Registration for sale of Medical Devices: Procedure and conditions

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

Notified Bodies for Medical Devices

Updated list of Notified Bodies for Medical Devices

Updated list of Medical Device Testing Laboratories (MDTLs)

Medical Device Alert: Lists

Forms: All types of Medical Devices

Schedules: All types of Medical Devices


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