An Overview of Grant of Test License for Import under MDR, 2017

Test License for Import
Karan Singh
| Updated: Oct 28, 2022 | Category: CDSCO

As per Section 40 of the MDR, 2017, any type of medical device or in-vitro diagnostic medical device may be imported to run any type of training testing, clinical investigation, etc. An individual (importer or manufacturer) who wants to import the medical devices of Class A, B, C, or D to India can get a Test License for Import under MDR, 2017, by Form MD-17. The Test License can be used for the purpose of testing, evaluation, training, or demonstration of Medical Devices. CDSCO or Central Drugs Standard Control Organisation, is the regulatory authority of India that issues the Test License for Import of Medical Devices in Form MD-17. To obtain a Test License for Import of Medical Devices, the applicant need to apply to the regulatory authority through Form MD-16 on an online website i.e., SUGAM. Scroll down to check more information regarding the grant of a Test License for Import under MDR, 2017.

What is the Primary Purpose of Form MD-16 and Form MD-17?

  1. Form MD-16: This is the application for a License to import medical devices to evaluate, train, test, demonstrate, or conduct clinical trials.
  2. Form MD-17: Permission is granted by the Central Drugs Standard Control Organisationto import medical devices for evaluation, training, demonstration, or conduct clinical trials through this Form.

Eligibility to Get Test License for Import under MDR, 2017

Any importer who wants to import medical devices in India can apply for this License via Form MD-16 along with the vital documents and requisite fees. This License is used for the purpose of testing, training, clinical investigation, demonstration, etc., of Medical Devices. The Test License for Import is issued by the CLA or Central Licensing Authority[1].

Various Conditions for Grant of Test License for Import of Medical Devices in India

The conditions for granting of Test License for the Import of Medical Devices are mentioned under Section 41 of the MDR, 2017. The conditions are as follows:

  1. The CLA, if completely satisfied with the fact that all the requirements for the application submitted in Form MD-16 comply with the Rules of the Act, shall issue a Test License in MD-17. The Central Licensing Authority conduct an investigation of the application form and may hold an enquiry. In case the CLA is not satisfied, it may cancel the application and is required to submit the cancellation reasons in writing within 30 days from the submission date of the application, as per Rule 40 of the Sub-Rule (2).
  2. The validity period of this License is 3 years from the date of issue of the Test License unless it is cancelled.
  3. The CLA can issue a show cause notice to any licensee or License holder if he or she is found to be breaching any rules, asking the License holder or Licensee for the reasons why his/her License should not be cancelled.
  4. The License holder is given an opportunity or a chance to explain in writing the reasons in their defence. If the CLA will pass an order for the cancellation of the Test License or otherwise & record the reasons for passing the said order.
  5. The Medical Device for which the License has been issued is to be used for testing, training, demonstration, clinical investigation, etc. According to Sub-Rule (1) & such purposes are supposed to be carried out only at the premises or units which is specified in Test License. If in any instance, where the Medical Devices are taken to any area or place other than the one stated in the Test License, the CLA should be informed in writing before taking action.
  6. The Medical Devices at the time of import shall comprise the invoice, which includes the name & quantity of the medical device.
  7. The medical devices and in-vitro diagnostic medical devices, as mentioned in Sub-Rule (2), which aren’t being used, may be allowed to be destroyed or exported after importing the CLA.
  8. A License holder whose License has been revoked by the CLA, may file an appeal to the Central Government of India within 40 days from the date of order.
  9. The owner of the Test License is required to maintain the record of all the main activities undertaken along with the manufacturer name, import date & the quantity imported.

Essential Documents Required to Obtain Test License for Import of Medical Devices

Following are some important documents required for obtaining a Test License for Import of Medical Devices in India:

  1. Application Form;
  2. Covering Letter;
  3. Product label & Brochure;
  4. Testing protocol;
  5. The description of the medical devices or in-vitro diagnostic kit;
  6. The description must include materials of construction, design label, intended use & instructions for the use of the Medical Devices;
  7. FSC or Free Sale Certificate in the Country of Origin;
  8. Ethics Committee Approval (if applicable);
  9. TR-6 Challan Justification or Utilisation.

Step-by-Step Process to Apply for Test License for Import of Medical Devices

Following is the process to apply for a Test License for Import of Medical Devices:

  1. First, the applicant needs to register on the SUGAM portal.
  2. Then, the application for the License must be drafted in Form-16 along with the vital documents.
  3. After that, the applicant needs to pay the fee along with submitting the required documents.
  4. The application is to be submitted on the online portal.
  5. After the approval by the concerned authority, the Test License for Import will be issued in Form MD-17.

Conclusion

In 2020-21, there has been an exponential growth in the import of medical devices in India of 41% of around Rs. 63,000 crores. In India, the demand for medical devices is high and is regulated by the Central Government through CDSCO for better transparency & service.  To get Import License for Medical Devices in India, the importers are required to comply with CDSCO’s Regulations. However, because of the complex system of getting a License, many manufacturers find the process extremely taking consuming & confusing. The process complexity is the reason why it is necessity to take legal assistance and support for getting a Test License for Import of Medical Devices.

Read our Article:What is the Meaning of Form MD-8 and Form MD-10?

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Karan Singh

A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.

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