Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on May 20, 2024 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 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. 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 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 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 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 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 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: 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
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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)
Forms: All types of Medical Devices
Schedules: All types of Medical Devices
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