**Summary:**
The Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, announces the implementation of an online application system for Free Sale Certificates, Market Standing Certificates, and Non-Conviction Certificates for notified Medical Devices. Effective immediately, applicants must submit applications through the Online System of Medical Devices portal: https://cdscomdonline.gov.in, adhering to the prescribed checklist. Certificates will be issued by the relevant licensing authorities (Central Licensing Authority/State Licensing Authority) responsible for issuing the original license. Offline, hard copy submissions will not be accepted after September 46th, 2020. This notice, reference number F. No. 29Misc032020DC 205, is issued by Dr. V.G. Somani, Drugs Controller General, and is directed to all stakeholders via the CDSCO website, State/U.T Licensing Authorities, and the CDAC Team.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Medical Devices: Refers to the category of products regulated under the policy, including diagnostic devices.
Free Sale Certificate: A certificate required for exporting medical devices, indicating that the device is freely sold in the country of origin.
Market Standing Certificate: A certificate indicating the market presence and standing of a medical device.
Non-Conviction Certificate: A certificate attesting that the manufacturer has not been convicted of any regulatory violations.
Online System of Medical Devices portal: The online portal (https:cdscomdonline.gov.in) for submitting applications related to medical devices.
Central Licensing Authority: The central authority responsible for issuing licenses for medical devices.
State Licensing Authority: The state authority responsible for issuing licenses for medical devices.
F. No. 29/Misc/03/2020-DC (205)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Medical Device & Diagnostic Division)
FDA Bhawan, Kotla Road,
New Delhi - 110002
— Dp 9N on
NOTICE
Sub: Online Application for Free Sale Certificate, Market Standing Certificate and
Non-Conviction Certificate of notified Medical Devices - reg.
In order to streamline the regulatory submission procedure, the submission of
applications for issuance of Free Sale Certificate, Market Standing Certificate and
Non-Conviction Certificate of notified Medical Devices is now functional on Online
System of Medical Devices portal (https://cdscomdonline.gov.in). The applicants
seeking for such certificates may now apply through online portal as per the checklist.
It is pertinent to mention that such certificate will be issued by the licensing authorities
(Central Licensing Authority/ State Licensing Authority) who have issued the license.
The offline submission (hard copy) for such applications will not be accepted after 46 th
September, 2020.
\e
(Dr. V.G. Somani)
Drugs Controller General (I)
To:
1. All stakeholders through CDSCO Website
2. State/U.T Licensing Authorities (For information and necessary action)
3. CDAC Team