FAQs – on Blood Pressure Monitoring Devices
Q 1: Whether Blood Pressure Monitoring Devices is a drug?
Ans: Yes it is drug as per section 3(b) (iv) of the Drugs and Cosmetics Act, 1940. Further, by virtue of definition of drug under section 3 (b) (iv) and rule 2 and 3(zb) of the Medical Devices Rules, 2017, it is medical device.
To read / download MDR 2017, click here
Q 2: When Blood Pressure Monitoring Devices is notified as medical devices?
Ans: It was notified as medical devices vide S.O. no. 5980(E) dated 03.12.2018 (effected date is 01.01.2020), then vide S.O. no 4671(E) dated 27.12.2019 It has been given relaxation in the implementation. Now, and then effected date is 01.01.2021.
To read / download notification S.O. no. 5980(E) dated 03.12.2018, click here
To read / download notification S.O. no. 4671(E) dated 27.12.2019, click here
Q 3: Whether after 01.01.2021, Blood Pressure Monitoring Devices is regulated?
Ans. Yes, it will be regulated wef 01.01.2021 under Medical Devices Rules, 2017. Further, in view of order of DCGI issued vide F. No. 29/Misc/03/202-DC (297) dated 28.12.2020, existing importer/manufacturer who is already importing / manufacturing BP Monitoring Device, has submitted application for grant of import / manufacturing Licence to CLA / SLA may continue to import / manufacture it upto 6 months or till CLA / SLA decides on the said application, whichever is earlier.
To read / download DCGI order dated 28-12-2020, click here
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Q 4: What are the types of medical devices notified along with Blood Pressure Monitoring Devices?
Q 5: Who will issue license for the manufacture of Blood Pressure Monitoring Devices?
Ans. DCGI vide Notice dated 15.05.2019 has classified Blood Pressure Monitoring Devices as per the risk as Class ‘B’ medical device. As per Medical Devices Rules, 2017, Licence to manufacture Class A and Class B shall be granted by State Licensing Authority.
To read / download DCGI order dated 15-05-2019, click here
Q 6: Whether any sale license is required for sale of Blood Pressure Monitoring Devices?
Ans. Yes, as per rule 87 of Medical Devices Rules, 2017, sale license Drugs Rules, 1945 is required wef 01.01.2021 for sale of the said Medical Device.
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