The Manufacturing License for sale and distribution of Class C and Class D In- Vitro Diagnostic Kits are regulated by the Central Licensing Authority. The application for obtaining Manufacturing License for the intended In- Vitro Diagnostic Kits and reagents in Class C & D is filed in Form MD-7 and the application for obtaining loan licence is filed in Form MD-8 along with prescribed fees. Before grant of licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site shall be inspected within a period of sixty days from the date of application by a registered notified body.
After completion of inspection as referred to in rule 23, the inspection team shall forward a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central Licensing Authority, through online portal of the Ministry of Health and Family Welfare in the Central Government and forward a copy of the same to the applicant.Then the performance evaluation of the notified diagnostic kit is evaluated in NIB (National Institute of Biologicals), Noida.
After satisfactory compliance of the licensing process, the permission to manufacture In-Vitro Diagnostic Kits and reagents for sale and distribution of Class C & Class D In-Vitro Diagnostic Kits and reagents is obtained in Form MD-9 and the permission to obtain loan license to manufacture In-Vitro Diagnostic Kits and reagents for sale and distribution of Class A & Class B In- Vitro Diagnostic Kits and reagents is obtained in Form MD-10. A licence or loan licence issued shall remain valid in perpetuity, subject to payment of licence retention fee as specified in the Second Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the Central Licensing Authority. If the license is rejected then re-audit is done for the notified diagnostic kit.
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