Latest Notifications: Medical Devices

Last Updated on September 18, 2023 by The Health Master

Download the Latest Notifications: Medical Devices

The Govt. of India issues notifications from time to time, which are published by the 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 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-157E-dt-01-03-2023-Draft-Medical-Device-Rule-2023-State-Medical-DEvice-Testing-Laboratory

2022

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

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

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

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

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

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.-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

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

GSR-174E-dt-04-03-2022-Amendment-of-Rule-363-MDR-to-include-United-Kingdom-under-MDR-2017

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.-23E-dt-18-01-2022-Draft-Notification-Rule-43-Suspension-and-cancellation-of-license-of-Medical-Devices

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

2021

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

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

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

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

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

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

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-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.-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

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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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Revised Schedule M: CDSCO organizes nationwide Workshops

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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Banned Drugs

Blood Bank / Centre

Cosmetics

COTPA

DPCO / NPPA

Drugs Act

DMROA

EC Act

General

Homoeopathic

Hospital – RMI

NDPS Act

New Drugs

Testing Laboratories

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