Last Updated on January 9, 2024 by The Health Master
Download the Notification No. S.O. 775(E) dated 08-02-2019: The Central Drugs Standard Control Organisation (CDSCO) has said that the importers and manufacturers of medical devices, i.e. all implantable medical devices, and seven electronic medical devices, including CT scan and MRI equipment, can continue their imports or production up to June 30, 2022, if they have submitted an application for licence with the Organisation before April 18, 2021.
The industry was earlier mandated to take the licence with effect from April 1, 2021 and the timeline was extended for six months till October, 2021, considering the request from the industry representatives.
The Union ministry of health and family welfare has notified vide notification No. S.O. 775(E) dated 08-02-2019 the following devices as drugs with effect from April 1, 2021:
- All implantable medical devices,
- CT scan equipment,
- MRI equipment,
- Defibrillators,
- PET equipment,
- Dialysis machine,
- X-ray machine
- Bone marrow cell separators
According to this, importers and manufacturers were required to obtain an import / manufacturing licence from Central Licensing Authority or State Licensing Authority for the import or manufacture of these devices with effect from April 1, 2021.
However, the industry representatives requested to extend the implementation of the notification for another three to six months because of procedural work needed, including resolution of queries, audit of facilities by the regulators and notified bodies, and testing of products at the requisite testing labs, etc.
Considering the representations, the CDSCO on April 18 said that if the importers and manufacturers have submitted the application to the relevant authority for a grant of licence, the application shall be deemed valid and the applicant can continue to import or manufacture the said devices up to six months from the order.
Considering that the timeline falls due in the midst of October, industry representatives further raised their concerns that due to C-19 disruption, there is unpreparedness in complying with regulatory requirements within the prescribed timelines, which may lead to disruption of the supply chain and access to patients.
Following this, the CDSCO, in an order issued on November 3, said that in order to ensure smooth transition of manufacturers and importers, continuity of supply chain and access to patients, with the approval of the ministry of health and family welfare, it has been decided that in the case of an existing importer or manufacturer who is already importing or manufacturing any of these devices, and whose application has been submitted to the Central or State license authority for grant of license under the provisions of the Medical Devices Rules, 2017 by April 18, 2021, the said application shall be deemed to be valid and the importer or manufacturer can continue to import or manufacture the said devices up to June 30, 2022 or till the Central or State license authority takes a decision on the said application, whichever is earlier.
Further, the applicant, in case has submitted an incomplete application on or before April 18, 2021, is required to ensure submission of all the necessary documents to the concerned authority by March 31, 2022.
The “Central Licensing Authority or State Licensing Authority, as the case may be, shall dispose of these applications within three months from the date of receipt of the complete application,” added the order.
Besides, the importer or manufacturer of these medical devices has to obtain an import / manufacturing license for the devices by or before June 30, 2022 and the importer or manufacturer shall necessarily be required to print the license number on the label with effect from July 1, 2022, added the Organisation.
The extension of timeline has been demanded by the Association of Indian Medical Device Industry (AiMeD), which said that the industry needed more time to comply with the requirements considering the C-19 pandemic and resulting situation.
It may be noted that the ministry of health, in mid-October, also relaxed the ISO compliance norms for medical devices to register with the CDSCO, in a relief to the medical device industry.
The medical device manufacturers complained that they could not get the registration done by September 30, when the timeline for voluntary registration ended, due to difficulties in getting the ISO certification amidst the C-19 pandemic and related disruption.
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