CDSCO issues a Guidance Document on obtaining Free Sale Certificate of Notified Medical Devices; applicable to those manufacturers who export Class A/B/C/D medical devices
The Central Drugs Standard Control Organisation (“CDSCO”) has issued a Guidance Document on Free Sale Certificate of Notified Medical Devices to provide guidance to Indian Manufacturers for submission of application for Free Sale Certificate to CDSCO. This is applicable to those medical device manufacturers in India who are having valid manufacturing license and intent to obtain Free Sale Certificate for export of Class A, B and Class C, D medical devices.
Rule 91 of the Medical Devices Rules 2017 (“Rules”), deals with export of medical device. When a person intends to export any medical device, which is manufactured in India, he has to apply for a certificate in the nature of free sale certificate or a certificate about quality, safety and performance in relation to that medical device as required by the authority concerned of the importing country. If the needful requirements are fulfilled, the Central Licensing Authority will issue a certificate to the applicant. The CDSCO has issued the guidance document in line with Rule 91.
[Note: The Medical devices are classified on the basis of parameters specified in Part I and Part II of the First Schedule of the Rules ( pages 167-172) .The classifications are made in the following manner:
(i) low risk – Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D. ]
Actionable on part of such manufacturers:
- Make an application to Central Licensing Authority for obtaining Free Sale Certificate of Notified Medical Devices.
- Write a cover letter along with application clearly specifying the intention of the application and the list of documents submitted.
- Pay the requisite fees prescribed in second schedule of Rules for Certificate to export medical device. The applicant will have to make a payment of 1000 INR for obtaining Free Sale Certificate for each distinct medical device through challan or by electronic mode in prescribed banks notified by the Ministry of Health and Family Welfare in the Central Government.
- Submit 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.
- Submit a list of products for which the Free Sale Certificate is required.
- Submit undertakings 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.