InVitro Diagnostic Device Import license
New Medical Device Rules, 2017, govern the import of Invitro Diagnostic. Central Drugs Standard Control Organisation has made an online platform.
SUGAM, for submitting applicants and granting permission of Import of IVD falling under any Category A,B,C or D respective online form is required to be submitted on SUGAM, which is a central Licensing Authority for such products.
Crucial document required for the license to import InVitro diagnostic devices:
In accordance with part II of the IV schedule of the New Medical Rules of 2017, the applicant must provide the different documents that are needed for import registration.
- Covering Letter.
- Attachment of Regulatory and Other Required Documents in accordance with Form MD 14
- Power of Attorney.
- The ISO13485 Certification.
- Challan TR 6.
- GMP Certificate.
- CE Design Certificate.
- Confirmation Statement.
- PMS analysis.
- Certificate of Plant Registration and Business License.
- Report on Audit.
- The Indian Agent's Constitutional Details.
- A current license from the manufacturer or wholesaler approved in India to register the import of InVitro diagnostic kits.
- A quality certificate from an international manufacturer confirming the product's excellence.
- A no-cost transaction It is necessary to present the Certificate FSC with the application. The FSC is a crucial document that guarantees that proposed imports of InVitro devices are sold freely in the exporting nation and that export and trade liberalization are approved.
- Certificate of Batch Release.
- Comprehensive Test Report.
- It is required of the applicant to specify if the application is for registration or re-registration.
- A list of required documents should also be included in the letter.
- An authorized signatory must properly sign all required documentation.
- Specifics of the Imported Goods.
- Specifics of the production location.
Products Covered Under InVitro Diagnostic Device Import License
Consumer Products
Industrial Products
Specialized Products
Key Points:
A few key considerations need to be made before submitting an application for a Medical Device Import license.
Our Certification Process
- It is necessary to confirm whether the "Free Sale Certificate: from GHTF countries" is available.
- Verify how many manufacturing locations are included in the application.
- The format of the Power of Attorney must follow the instructions in the 2017 Regulation of Medical Device Rules..
- The needed documentation for the Site Master File, Device Master File, and any technical documentation must also comply with the 2017 Medical Device Regulations.
- The Apostillation and Notary must also adhere to the 2017 Medical Device Regulations Guidelines.
- An agency located in India is regarded as an authorized agent for the purpose of granting a Vitro Diagnostic Device license.
Validity of Invitro-Diagnostic Device Import License in India
As long as the license retention fees are paid as specified in the second schedule before the license's five-year expiration date, the import license issued on form MD-15 is perpetually valid. This is only carried out in the event that the Central Drugs Standard Control Organization has not suspended or revoked the license.
