According to the Medical Device Rules (MDR) 2017, a small quantity of Class A, B, C, and D medical devices can be manufactured to perform clinical investigation, test, examination, demonstration or training. For this reason, an application form is made in the form MD-12 and is required to be submitted to the Central Licensing Authority, along with the required fee, which is specified in the Second Schedule. The Central Licensing Authority will then inspect all the necessary documents and, on being satisfied, will grant a test license for manufacture in Form MD-13, as per Medical Devices Rules, 2017.
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.
Scope of Medical Device Industry in India
The Revenue of the Medical Device Market is anticipated to reach around ₹ 466.80 billion in the year 2022, according to the India Brand Equity Foundation. The largest segment in Medical Device Market is covered by Other Medical Devices, with a market volume of around ₹ 246 billion in the year 2022. There is an anticipation in the growth rate of revenue by 13.01%, by the year 2027, with an approximate market volume of ₹ 860.30 billion. Although, in a global context, most payment is expected to be produced by the United States, resulting in a figure of around ₹ 13,020 billion in the year 2022.
Forms Required for Test License for Manufacture
To obtain the test license to manufacture, conduct a clinical investigation, test, examination, demonstration or training, the applicant must submit form MD-12 and the required documents to the central licensing Authority. The Central Licensing Authority may grant a test license to the applicant in form MD-13.
Documents required for Test License for Manufacture
To obtain a Test license for manufacture, as per Medical Device Rules 2017, there are a few documents which are to be attached along with the application made under sub-rule (1). The papers are as follows-
- A short detail of the medical device along with its intended use, materials used for manufacturing the device, product design, and an undertaking stating all the requirements that have been provided to manufacture that device.
- The list of all the required instruments and equipment
- List of qualified personnel involved in the process
- A copy of the manufacturing license which is issued under the Medical Device Rules, 2017 (if any)
- An approval letter which authorizes to conduct of research and development procedures, which is published by any government organization (if any)
Procedure to Apply for Test License to Manufacture
To apply for the test license to manufacture, conduct a clinical investigation, test, examination, demonstration or training, the applicant is required to follow specific procedures-
- 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-12 along with the essential documents.
- The government feed is to be paid along with submitting the required documents.
- The application is then required to be submitted on the medical device portal.
- After approval, the license will be provided in form MD-13.
Grant of Test License for Manufacture
The CLA or Central Licensing Authority, after checking all the rules and requirements are in compliance with the Medical Device Rules 2017, will grant a test license for manufacture in Form MD-13. The CLA is also authorized to reject the applications which do not comply with the requirements, where for such rejection, it is required to mention the reasons to the applicant in writing, within 30 days of submission of the application. The Licensee is required to have a record of the quantity of the product which is manufactured under the test license.
Validity of Test License for Manufacture
Under sub-rule (3) of the medical device rule 2017, the test license for manufacture is granted. The permit will remain valid for the period of three years from the date of issue unless it is cancelled by the authorities for some reason.
Conditions of Test License for Manufacture
The Central Licensing Authority or CLA, under the Medical Device Rule 2017, grants a test license for manufacture in Form MD-13, under rule 31.
The test license is subject to certain conditions, which are mentioned below-
- The medical device for which the test license has been granted shall only be used for clinical investigation, test, examination, demonstration or training at a place mentioned in the license.
- The Licensee has to allow any medical device officer to enter any manufacturing premise with or without notice to make sure that only clinical investigation, test, examination, demonstration or training is being conducted on the medical device.
- The Licensee should maintain a record of the number of medical devices manufactured, tested and stored, along with their disposition.
Cancelling of Test License for Manufacture
Central Licensing Authority may be unsatisfied with the inspection of specific conditions and requirements to grant the test license for manufacturing medical devices. The problem arises when any licensee under section 31 violates any of the Medical Device Rules 2017; the Central Licensing Authority then issues a show cause notice to the Licensee, questioning why the license shall not be cancelled. Licensee should answer in writing. After receiving the written answer submitted by the Licensee, the Central Licensing Authority may pass an order to cancel the license or otherwise and is required to record their reason for doing so. The Licensee whose license has been cancelled by the Central Licensing Authority may file an appeal to the Central Government within forty-five days of the date of order.
The medical device Industry is continuing to grow steadily in India in recent years. The development in Medical Technology and Increased investment result from the demand for innovative medical devices. Along with the advantages, the Industry is also facing some challenges in some complex regulatory processes, reimbursement restrictions, and the high cost of 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 manufacture of medical devices.
Read our Article:Grant of Test License for Import under MDR, 2017