66 Circular-Retention of license or certificates under Medical Devices Rules, 2017 2024-May-15 207 KB

F. No. MED-15/35/2024-eoffice Government of India Directorate General of Health Services Central Drugs Standard Control Organization (Medical Devices Division)

Food & Drugs Administration Bhawan, Kotla road, New Delhi-110002 Dated: b AA

Subject: Retention of license or certificates under Medical Devices Rules, 2017- reg.

You may be aware that the license for manufacturing or import of Medical Devices and Registration Certificate for QMS Audit by Notified Body as well as for Medical Devices Testing Laboratory is issued in perpetuity, provided a payment of requisite fee may be deposited in stipulated timeline under MDR, 2017 or unless: it is suspended or cancelled by the Licensing Authority.

Further, the endorsements to the licenses/certificates issued will also be valid till the validity of its base license/certificate. If the requisite fee is not deposited by the applicant as per stipulated timeline, the license/certificate shall be deemed to have been cancelled.

In view of the above, all the stakeholders are requested to ensure that the requisite fee may be deposited in appropriate account of the Government, well before the stipulated timeline under MDR, 2017 and also submit the application to the Licensing Authority in order to maintain continuity of the product in the market.

(Dr. Rajeev Singh Raghuvanshi) Drugs Controller General (India)

TO,

1. All stakeholders through CDSCO Website

2. Allthe Association of Medical Devices through email

3. All the Notified bodies through email

4. Allthe Medical Device Testing laboratory through email

,

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File No. MED-15/35/2024-eoffice (Computer No. 9100) Generated from eOffice by RAJEEV SINGH RAGHUVANSHI, DCI-RSR-CDSCO, DCG(I), CDSCO-HQ on 14/05/2024 04:58 PM