The Central Drugs Standard Control Organization (CDSCO) is the apex body under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India regulating manufacture, import, sale and distribution of all notified devices. Medical device Rules, 2017 published by CDSCO under Drugs and Cosmetics Act are applicable to all notified devices.
Govt. order S.O. 775(E) dated 08 Feb 2019 and S.O. 4672(E) dated 27 Dec 2019 regulate 8 new medical devices as drugs effective from 1st April 2021.
1. All Implantable Medical Devices
2. CT scan equipment
3. MRI equipment
4. Defibrillators
5. PET equipment
6. Dialysis machine
7. X-Ray machine
8. Bone marrow cell separator
CDSCO issued an order on 18 April 2021 that allows the importer/manufacturer to continue the import/manufacture of the said devices up to 6 months (i.e. up to 17 Oct 2021) or till the time licensing authority takes a decision on the applications under review, whichever is earlier. It is pertinent to note that extension is applicable only to the existing importer/manufacturer who HAS SUBMITTED application to CLA/SLA and is ALREADY IMPORTING/ MANUFACTURING the said devices in India.
It’s a significant decision taken by Government to ensure the supply chain continuity and access to these Medical Devices. The extension will support the completion of procedural work like resolution of queries, facility audits, product testing etc. for smooth transition to fully regulated regime under India Medical Device Rules, 2017. Different scenarios are discussed in detail below to be able to understand the applicability of referenced order:
As extension is valid “up to” 6 months or approval date whichever is earlier, the licensing authorities may decide/ approve submitted applications on any date prior to 17 Oct 2021 subject to the resolution of queries, audits etc. The applicants should be ready with labelling processes to provide license number on next imported/ manufactured stock as soon as licenses are issued.
Feel free to reach out to us at info@innoreg.in or submit online query in website www.innoreg.in for any assistance required with registration process of the said devices or other regulatory needs regarding medical devices registration in India.
References:
1.https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzE0Nw==, last seen on 18 April 2021
2. https://pib.gov.in/PressReleasePage.aspx?PRID=1712575, last seen on 18 April 2021
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