Home About Qualtech NEWS INDIA: Guidance Document on Free Sale Certificate of Notified Medical Devices in India - January 2019
INDIA: Guidance Document on Free Sale Certificate of Notified Medical Devices in India - January 2019

January 15, 2019

CDSCO India has recently issued a new guidance document on the application for Free Sale Certificate of notified medical devices in India. According to this guidance document, all applications, in the form of a hard copy (offline submission), must be made to the Central Licensing Authority by the manufacturer, having a valid License to manufacture for sale or for distribution of notified medical device. It specifies that the following attachments must accompany the application:

i)       A cover letter, which clearly specifies the intent of the application. The list of documents that are being submitted (Index with page no’s) as well as any other important and relevant information may be provided in the cover letter. The cover letter should be duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory along with the name and address of the firm.

ii)       A valid copy of license to manufacture for Sale or for Distribution of Medical Devices along with approved product list issued by State Licensing Authority or Central licensing Authority, as the case may be.

iii)       List of products for which the Free Sale Certificate is required.

iv)     Undertakings by the manufacturer stating that no action has been initiated against them due to adverse events, market complaint and Not of Standard Quality (NSQ) report of any product in India.

The requisite fees has been prescribed in second schedule of Medical Devices Rules 2017 for Certificate to export medical device. The Applicant shall make a payment of 1000 INR for obtaining Free Sale Certificate for each distinct medical device.

For more information on the application for a Free Sale Certificate from the Central Licensing Authority, kindly refer to the official Guidance Document at this link.

 

 

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Home About Qualtech NEWS INDIA: Guidance Document on Free Sale Certificate of Notified Medical Devices in India - January 2019