According to section 40 of the Medical Device Rules 2017, any kind of medical device or in-vitro diagnostic medical device may be imported in order to run any kind of clinical investigation, test, training, etc. Any person who is willing to import medical device is required to apply for a test license for the same. The application is submitted to the Central Licensing Authority or CLA in Form MD-16, along with the required fees which is specified in the Second Schedule. After receiving the application, the Central Licensing Authority is required to decide the quantity of the Medical Devices, after considering the facts like requirement for the test, approved clinical investigation plan, and the documents which are submitted by the applicant. Scroll down to check more information regarding Test License for Import.
Types of test licenses
According to the Medical device rules, there are two types of test licenses available for Medical Devices-
- Test licence to manufacture for a test, evaluation, clinical investigations, etc., as mentioned in section 31 of the Medical Device Rules, 2017.
- Test licence for import for a test, evaluation, clinical investigations, etc., as mentioned in section 40 of the Medical Device Rules, 2017.
As per section 92 of the Medical device rules 2017, the application for a test license of import or manufacture shall be rejected if it is found to be misleading or fake, after giving a chance to the applicant to clarify his reasons and be unsatisfied.
Medical Device Officer and Device testing laboratory
As per section 18 of the Medical Device Act 2017, The Central Government may designate a government analyst as a medical device testing officer or a medical device officer. The medical device testing officer may be a Government Analyst, who is appointed under sec 20 of the act, while the medical device officer may be an inspector, who is appointed as per section 21 of the act. As per section 19 of the Act, the Central Government may establish Central medical devices testing laboratory in order to conduct test and evaluation of medical devices or to make an appellate laboratory or for any other function.
Forms required for test license for Import
To obtain the test license to import for test, evaluation, clinical investigations, etc. the applicant must submit form MD-16 and the required documents to the central licensing Authority. The Central Licensing Authority may grant a test license to the applicant in form MD-17.
Conditions for grant of test licence of Medical Devices for Import
Section 41 of the Medical Device Rules, 2017 defines conditions for the grant of test licence for import for test, evaluation, clinical investigations, etc. The conditions are as follows-
- The Central Licensing Authority, if satisfied with the fact that all the requirements for the application submitted in Form MD-16 complies with the rules of the act, shall grant a test license in Form MD-17. The CLA may also hold an enquiry during the investigation process of the application form. If the CLA is not satisfied, it may reject the applications and is required to submit the reasons for rejection in writing within thirty days from the date of submission of the application¸ as per rule 40 of the sub-rule (2).
- The Medical Device for which the test licence has been granted, is to be used only for the purpose of clinical investigation, test, training, etc. as per sub rule (1), and such clinical investigation, test, training, etc. is supposed to be carried only at the premises which is specified in the test license. If in any case, where the Medical device is taken to any place other than the one specified in the test license, the Central Licensing Authority should be informed in writing before taking the action.
- The test license holder is required to maintain the record of all the activities undertaken, along with the manufacturer name, date of import and the quantity imported.
- The Medical Device during the import shall include the invoice which includes the name and quantity of the medical device.
- The validity period of the test license will be for a time period of three years from the date of Issue unless it is cancelled.
- The medical devices along with in-vitro diagnostic medical device as mentioned in sub-rule (2), which are not being used, may be allowed to be exported or destroyed under after informing the Central Licensing Authority.
- The Central Licensing Authority can issue a show cause notice to any licensee, if he is found out to be violating any provisions of the rules, asking the licensee for the reasons why his license should not be cancelled.
- The licensee is given an opportunity to explain in writing the reasons in his defence. If the Central Licensing Authority will then pass an order for cancellation of the license or otherwise, and record the reasons for passing the said order.
- A licensee whose license has been cancelled by the Central Licensing Authority, may file an appeal to the Central Government within forty five days from the date of order.
Eligibility for obtaining Test License for Import
Any importer or a manufacturer, who wants to import a small quantity of Class A, B, C or D medical devices to India is can apply for the test license by Form MD-16 along with necessary documents and required fee. The test license is used for the purpose of clinical investigation, test, training, etc. of medical devices. The Central Licensing Authority is responsible to grant test license for medical devices by form MD-17.
Documents required to obtain Test License for Import
- Application Form
- TR-6 challan justification/ utilization
- Covering letter
- Testing protocol
- Product label and Brochure
- Free sale certificate or FSC in the country of origin
- Ethics committee approval (If applicable)
- Notarised Agreement- If in case when a firm has applied for the CDSCO test license, and has used the testing facility of another firm, then the firm should also submit a copy of Notarized Agreement between two firms, completely authenticated by the applicant.
Procedure to apply for test license for Import of Medical Device
In order to apply for the test license for Import of Medical Device, the applicant must follow these steps:
- The registration on the SUGAM portal is an essential requisite for the process of applying for a test license. The applicant is required to register on the SUGAM portal first.
- The application must be drafted in Form MD-16 along with the essential documents.
- The government fees is to be paid along with submitting required documents.
- The application is then required to be submitted on the medical device portal.
- After approval, the test license for Import will be provided in form MD-17.
- The Validity of the document remains till one year from the date of issue.
There has been a rise in the import of medical devices of 41%, of about Rs 63,000 crores in the year 2020-21. Medical devices are in high demand in India and are regulated by the government, through CDSCO, for a better service and transparency. The Importers are required to comply with the regulations of CDSCO in order to obtain permission or license to import or manufacture the medical devices in India. However, due to a long and complex system of obtaining a license, many manufacturers find the entire process extremely confusing and time taking. There are major challenges in some complex regulatory processes, reimbursement restrictions, and the high cost in developing and advancing technology in the Medical Industry. The complexity of the process is the reason why it’s a necessity to get legal aid and support for obtaining a test license for import of medical devices.
Read our Article:Grant of Test License for Manufacture under MDR, 2017