Download the Notifications - Medical Devices

Govt. of India
issues Notifications time to time which are published by Department of
Publication and are printed by the Government of India Printing Presses
regularly.

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

2022

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

GSR-710E-dt-20-09-2022-Draft-notification-Exemption-of-certain-Class-A-medical-device-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-450E-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-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-228E-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-174E-dt-04-03-2022-Amendment-of-Rule-363-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-104E-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.-23E-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 notification - Registration number for Medical Devices - Medical Devices Rules, 2017

GSR-No.-19E-dt-18-01-2022-Draft-notification-Registration-number-for-Medical-Devices-Medical-Devices-Rules-2017

2021

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

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

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

GSR-850E-dt-10-12-2021-Draft-Amendment-of-Rule-363-MDR-to-include-United-Kingdom-1

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

GSR-729E-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

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

GSR-98E-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

S.O. -No.-1232-E-dt-31-03-2020-All-Medical-devices-under-DPCO

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

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.-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.-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

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-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. 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.-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.-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.-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

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

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

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-CT-Scan-MRI-X-Ray-etc

S.-O.-5980-E-dt.-03-12-2018-Medical-Devices-for-human-use-declared-as-Drug-CT-Scan-MRI-X-Ray-etc

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

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

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

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

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

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

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

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

Licensing procedure for Medical devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

FAQs on Medical Devices Rules, 2017

FAQs – on Blood Pressure Monitoring Devices

For more Notifications on following topics, click below links:

Banned Drugs

Blood Bank / Centre

Cosmetics

COTPA

DPCO / NPPA

Drug Rules

Drugs Act

DMROA

EC Act

General

Homoeopathic

Hospital – RMI

NDPS Act

New Drugs

Testing Laboratories
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