For the import of Class, A, B, C & D In Vitro Diagnostic Kits, applicant have to submit the documents as per Fourth schedule Part I, Part II and Part III (Appendix I & III, only), along with fee as per second schedule of the new medical device rules.
An authorised agent holding license to manufacture or wholesale licence for sale and distribution issued under MDR, 2017, may apply for grant of import license for IVD in Form MD- 14 to the Authority on behalf of the manufacturer. Thereafter, the license would be obtained in Form MD-15.
Our technical team at CliniExperts help our clients to obtain Import License.
The licensing process is regulated by the Ministry of Health and Family Welfare in the Central Government. The Central Drugs Standard Control Organization (CDSCO) has created a separate online portal for the security of Pre-registering the Applicants before filing for the registration of their intended In Vitro Diagnostic Kits in India.
An Online Licensing Portal of CDSCO has been launched on 14 November, 2015 and has been named “SUGAM”. It is a reliable, fast, and spam-free portal that has been launched by the Ministry of Health & Family Welfare. Our Team of Experienced Professionals will be Happy to Serve you for Sugam Registration.
The applicant is required to submit various documents required for import registration in India as specified in the Part II of the fourth schedule of the new medical device rules.
The documents include a cover letter in proper format mentioning all the relevant details of the intended product and the manufacturing site details required filing an import license application. We at CliniExperts help our clients with preparing an appropriate cover letter for filing the application.
Furthermore, the applicant needs to submit a valid wholesale/manufacturer license of Indian agent for the registration of In Vitro Diagnostic Kit. This is a mandatory requirement for filing an application. The applicant also needs to submit a free sale certificate (FSC) with the application. A Free Sale Certificate (FSC) is a document which denotes that the intended In Vitro Diagnostic device being imported are freely sold in the open market in the exporting country and are approved for export and trade liberalization.
The supporting documents also includes quality certificates of foreign manufacturers ensuring the device being imported is of good quality. Apart from these documents, the application for In Vitro Diagnostic Kit should also be accompanied with other essential documents like a device master file, which specifies the technical, clinical and safety related information and test data of the medical device being imported, a plant master file which specifies details about the manufacturing procedure of the In Vitro Diagnostic device, the details of source antigen or antibody as the case may be and characterization of the same, process control of coating of antigen or antibody on the base material like Nitrocellulose paper, strips or cards or ELISA wells etc, detailed composition of the In Vitro Diagnostic medical device and manufacturing flow chart process of the In Vitro Diagnostic medical device and test protocol showing the specifications and method of testing.
In case of imported diagnostic, the report of evaluation in details conducted by the National Control Authority of country of origin, specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter, the detailed test report of all the components used/packed in the finished in vitro diagnostic medical device, pack size and labeling, product inserts, specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device and specific processing details like safe handling, material control, area control, process control, and stability studies are a perquisites for the submission and needs to be highlighted in the product dossier.
We help our clients apply for Import License and ensure the process is quick and hassle free. For more information on the same or any query, please feel free to reach us at firstname.lastname@example.org or +91-767 20 05 050