Medical Devices

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:

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-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

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


Also read for more details on licensing process of Medical devices, click here


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