The license to import in-vitro diagnostic kits (IVD) is regulated in India under two regulatory provisions – Drugs & Cosmetics Act 1940 and Drug & Cosmetics Rule 1945. Import license for in-vitro diagnostic is received in “Form MD 15” as per Medical Device Rules 2017. The application form that needs to be filled to get the grant of IVD import license is “Form MD14”. For the import license of predicate in-vitro diagnostic medical devices (Notified), the products (IVDs) and Manufacturing site need to be registered with the Indian Drug Regulatory Agency called Central Drugs Standard Control Organization (CDSCO). An authorized agent having either of the below-listed licenses can apply to the CDSCO for the grant of import license:
An authorized agent having either of the below-listed licenses can apply to the CDSCO for the grant of import license:
|Evaluation of the product, if it requires registrations MDR 2017 (Regulated/Non-Regulated)|
|If requires registration, Evaluation of classification (Class A,B,C,D) based on the product risk category|
|Mandatory document requirement Sharing the list Review for its adequacy|
|Appoint authorize agent|
|Online generation of application|
|Approval/confirmation of draft application by the authorize agent submission of application|
|Follow-up with regulatory authority and Query management if any|
The Import License in form MD-15 can remain valid forever if the fee for Licence Retention as specified in the Second Schedule is paid before the 5 year period from the date of its issue ends. This is if the license is not suspended or cancelled by the CDSCO.
The Government Timeline for Import License Form 15 for in-vitro Diagnostic kits is 6-9 months.
Some Key points, you must pay attention before applying for the medical devices import license.
Check availability of “Free Sale Certificate: from the GHTF Countries.
Check the number of manufacturing sites involved in the application.
Power of Attorney must be submitted in same format as shown in MDR 2017 (Guidelines for Regulation of Medical Devices,2017).
Any technical documents including Device Master and Site Master Files need to be prepared as per the format given in MDR 2017.
Prior permission by CDSCO by filling “Form MD-29” will be required for applications that do not have a “predicate device”. No licenses will be granted to import such devices without this permission.
All notary and apostillation of the documents should be done according to the guidelines in MDR 2017.
An authorized agent must be appointed. An authorized agent is the one who has any one of the following licenses.
CliniExperts professionals strive to provide the unrivalled assistance to streamline the process of licensing and regulatory approvals to Import In-Vitro Diagnostic (IVD) Kits in India as per Medical Devices Rule 2017.
The Power of Attorney (POA) is the base of the application process for obtaining “Import License for in-vitro diagnostic medical devices.” Therefore, it should be prepared very meticulously.
The product name and model numbers must be in line with POA, FSC, Label and Instructions for use (IFU) and other technical documents.
The products should be grouped correctly according to the Grouping Guidelines on Medical device issued by the MoHFW Govt. If it is not done, it may incur additional Government fees.
The major changes post approval of IVD as per the Sixth Schedule are any changes in:
A new agent has to submit all necessary legal documents like MD 14, the new Power of Attorney, government fees, wholesale or manufacturing licenses, label, IFU, and a copy of the import license issued to the former agent. Additionally, an undertaking from the manufacturer must be submitted stating there is no change in the device master file, plant master file, and other regulatory documents submitted to CDSCO by the previous agent along with their name, address & import license number for registration. When in doubt, take the help of a consultant to make sure your documentation is in place.
No. However, if the Central Licensing Authority finds it necessary, it may carry out an inspection of the overseas manufacturing site before the grant of import licence.
No. It is not mandatory to initially stock them in the warehouse address that is listed in the import Licence. IVD medical devices having a valid Import Licence, can be imported from any notified ports of India. They can be stored and distributed from any registered warehouse.
Yes, IVD medical devices imported under a valid Import License can be stocked in any wholesale Licence premises other than stated in the Import Licence.
The applicant has to submit performance evaluation reports (PER) for three independent batches of IVDs, manufactured using three different lots of “key” raw materials (e.g. Antigen, antibody) for the grant of the Import license.