Are you a manufacturer of a small quantity of medical devices in India then you must apply test license for medical devices. It is mandatory to get approval to apply test license for manufacturer of medical device to regulate medical devices. So obtaining this ELT corporate team will help you apply for this test license with the end-to-end practical solution by seeking forms 12 and 13.

It is classified as Class A, Class B, Class C, or Class D in India provided by CDSCO. Applications such as clinical research, testing, assessment, demonstration, and teaching are intended uses for these devices. To begin producing medical devices, the first step in the procedure is to apply for a Test License using Form MD-12 through the Ministry of Health and Family Welfare’s official website. Activities about testing, evaluation, demonstration, and training are expressly permitted by this license. The Ministry will grant the Test License on Form MD-13 after receiving the application.

What is the Importance of a Test License for Manufacture of Medical Device?

Before applying for a test license from a medical device manufacturer you must understand the importance of it. This will help you to understand why test license for the manufacturer is required:

• Purpose-Specific Usage – The test license is necessary to guarantee that medical devices are only used for specific purposes, including testing and evaluation, as opposed to being distributed commercially.
• Regulatory Requirements – Before being used or marketed, all medical devices—imported or produced in small quantities must need prior clearance or registration under India’s Medical Device Rule 2017.
• Patient Safety – A strong regulatory framework, which includes the test license, is required to guarantee that medical devices fulfil safety and performance criteria before going on sale, given the substantial influence that these devices have on patients’ health.
• CDSCO’s Role – The Central Drugs Standard Control Organization (CDSCO) is responsible for advising producers through the regulatory processes and helping them get test licenses.

How To Apply Test License for Manufacture of Medical Device?

If you are willing to apply for the test license for the manufacturing of medical devices then you must understand the process of it. It is necessary to obtain this license for regulatory approval. The state drug licensing authority grants the test license. The application process is as follows:

Register On SUGAM PORTAL

To obtain the license you must apply your application through the SUGAM PORTAL. First, create your account on the portal or if you are already a user then must log in to it. Through this portal, you can apply for a test license for a medical device for manufacturing.

Collect All The Documents

The application must be drafted as per Form MD 12. As per the MD 12 form, you must attach all the necessary documents that is mandatory to attach with the form application.

Pay Government Fee

When you submit your application then you must also pay the government fee as per the government guidelines in India. Then the application must be submitted on the medical device portal once you pay a fee.

Fill The Form MD – 13

When your application is approved then you must apply for the grant of license through the form MD – 13. Fill the form and apply for approval. They will check the application and if they are satisfied then they will grant the test license of medical device manufacturing to manufacturers.

Validity Of License

Once, you obtain the license then the license is valued for one year from the date of issue. Before expiry, you must apply for the renewal of the medical device manufacturing test license in India.

Documents Required For Test License For Manufacture of Medical Device.

According to the Medical Device Rules 2017, there are a few documents that are to be attached along with the application made under sub-rule (1) to obtain a Test license for manufacture. The documents are as follows,

• A small detail of the medical device to be manufactured along with its intended use, materials used for manufacturing the device manufacturing, product design, and an undertaking that states all the requirements that have been given to manufacture that device.
• List of all the required equipment and instruments 
• List of qualified personnel involved in the process of manufacturing
• The manufacturing license copy which is granted under the Medical Device Rules, 2017 (if any)
• An approval letter that provides authorisation to conduct research and development procedures, which is published by any of the government organizations (if any)

Forms Required For Test License For Manufacture of Medical Device

1. Firstly submit it MD – 12 application.
2. Then provide required documents to the Central Licensing Authority to obtain the test license to manufacture.
3. After this respected authority will conduct a clinical investigation, test, examination, demonstration or training. 
4. In the end, if all goes well form MD-13 the Central Licensing Authority can be issued as a test license for the manufacture of medical devices to the applicant.

What is the Applicable fee for a Test License for Manufacture?

The applicable fee for test licenses for manufacturers of district medical devices can be 500 for each or depends on the latest updates by the government. However, it’s advisable to directly contact the best regulatory consultancy in Delhi, to get accurate details about the price.

Grant Of Test License For Manufacture of Medical Device

After checking all the rules and requirements comply with the Medical Device Rules 2017 the CLA (Central Licensing Authority) will grant a test license for manufacture in Form MD-13. The CLA also has the authority to reject applications which do not comply with the requirements, where for such rejection, within 30 days of submission of the application it is needed to specify the reasons to the applicant in writing. The Licensee needs to have a record of the product quantity which is manufactured under the test license.

What are the Conditions Of Test License For Manufacture of Medical Device?

Under the Medical Device Rule 2017 the Central Licensing Authority or CLA, grants a test license for manufacturing the medical device in Form MD-13, under rule 31. The test license for manufacture is subject to certain conditions, which are specified below-

• For clinical investigation, test, examination, demonstration or training at a place specified in the license the medical device for which the test license has been granted shall only be used.
• The Licensee has to allow any medical device officer to enter any manufacturing process with or without notice to ensure that only clinical investigation, examination, test, demonstration or training is being conducted on the medical device.
• The Licensee must maintain a record of the no. of medical devices manufactured, stored and tested along with their disposition.

Validity Of Test License For Manufacture

The test license for manufacture is granted Under sub-rule (3) of the Medical Device Rule 2017. The validity period of the test license for import will be for three years from the date of Issue, after the validity period it is cancelled by the authorities for some reason.

Cancellation Of Test License For Manufacture of Medical Device

Central Licensing Authority cancels the test license for manufacturing medical devices when it may be unsatisfied with the inspection of specific conditions and requirements to grant the test license for manufacturing medical devices. When any licensee under section 31 violates any of the Medical Device Rules 2017 the problem arises; then a show cause notice to the Licensee issued by the Central Licensing Authority, and questioning why the test license shall not be cancelled.

The Licensee must answer in writing. After receiving the written answer, an order to cancel the license may be passed by the Central Licensing Authority or otherwise and is needed to record their reason for doing so.  Within 45 days of the date of order, the Licensee whose license has been cancelled by the Central Licensing Authority may file an appeal to the Central Government.

Conclusion

In recent years the medical device Industry is continued to grow steadily in India. The continuous development of medical device technology and increased investment have resulted in an increasing demand for innovative medical devices. Along with the merits, in some complex regulatory processes, the Industry is also facing some challenges, reimbursement restrictions, and the high cost of advancing and developing technology in the Medical Industry.  For obtaining a test license for the import of medical devices the complexity of the process is the reason why it’s a necessity to get legal aid and support.