If you are willing to import medical devices, then you must understand the test license. It is mandatory to obtain it as per the CDSCO guidelines. To get this understanding of the procedure for applying for a test license for medical devices import,

As per Section 41 of the Medical Device Rules, 2017, it is necessary to import tests, evaluations, clinical investigations, etc. Here, you will get to know about the process & what the test license is.

What Is a Test License For Medical Devices?

The test license for medical devices is the permission that is issued by the regulatory authorities that allows the manufacturing and importers to import/produce less than no medical devices independently for evaluation, testing, or research purposes.

Purpose – It helps to ensure that the medical devices meet the safety, performance, quality, and performance standards. 

Regulation –  A test license for medical device import is issued by the higher authority commonly known as a CDSCO. This makes sure that compliance follows all the legal demands during the testing phase.

Restriction – A medical device import test license is restricted to a precise quantity of devices, and it does not allow commercial sales.

What Testing Is Required For Medical Devices?

A medical devices import test license is required to make it clear that those products are safe, efficient, and reliable. Here, you can check every kind of medical device testing license for Import:-

Safety Testing 

• Electrical Safety – To check that the medical device does not cause electrical shocks.
• Biocompatibility – Assures that the materials used in the medical devices are safe if they come in contact with the body.
• Infection Risk – Analysing if there is any chance for the medical device to be a reason for infection.

Usability Testing 

• Ease of Operation – It helps check whether the pharmaceutical device is simple for patients and medical staff to use.
• Instruction Clarity – Verifies that all the instructions are easy to understand.

Durability Testing 

• Stress Testing – Subjecting the devices to conditions they can face in everyday use to make sure they hold up.
• Condition Testing – Check medical devices in every kind of situation, such as high temperature or humidity.

Regulatory Testing 

• Compliance – Following the FDA and CDSCO guidelines.
• Approval Requirements – Assembles to all requirements to check 

Performance Testing 

• Functionality Checks – Checks that the device is properly working for its intended use.
• Accuracy – Make sure devices are providing reliable results.

How To Apply For a Medical Devices Import Test License?

The applicant must follow the steps given below to apply for the test license for the Import of Medical Devices:

• Sign Up for Application – Registering on the SUGAM portal is an important requisite for applying for a test license. First of all, the applicant is needed to register on the SUGAM portal.
• Fill Up the Details – Fill all the required information on the application. Individual needs to provide all personal and organizational details.
• Documentation – Submit all the documents as it is mandatory to submit all the documents. As it is mandatory for the CDSCO Test License.
• Verification of the Registration – User have to click on the provided link that is sent to registered email id to activate your account on the SUGAM portal, test license for medical device import.
• Approval from the Authority – Afterwards, the application of the registration will be provided respected authority for license approval.

Forms Required For Test License For Import

The applicant should submit form MD- 16 and the required documents to the Central Licensing Authority to obtain the test license for medical devices import for tests, evaluation, clinical investigations, etc.  In form MD-17, the Central Licensing Authority may issue a test license to import medical devices to the applicant.

Documents Required To Obtain Test License For Import

Here we have provided all the important documents that are 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-   The firm should also submit a copy of the Notarized Agreement between two firms when that firm has applied for the CDSCO test license and has used the testing facility of another firm wholly authenticated by the applicant of the test license.

Benefits Of Obtaining a Test License For Medical Device Import

CDSCO test license for medical devices import offers numerous benefits:-

Quality & Safety of Products – CDSCO registration ensures that cosmetic products are safe to use and do not include any harmful chemicals. 

Legal Compliance – It represents the company following all the legal rules. 

No Custom Stopage – Securing a CDSCO License shows that you are transparent and following all the legal laws

Conditions For Grant Of Test Licence For Import of Medical Devices

According to Section 41 of the Medical Device Rules, 2017, conditions for the grant of test licenses for Import for tests, evaluation, clinical investigations, etc, are defined as follows.

The conditions are given below:

Test License Approval Process and Rejection Procedure 

If all the requirements satisfied for the application submitted in Form MD-16 comply with the rules of the act, the Central Licensing Authority shall grant a test license in Form MD-17. During the application form investigation process, the CLA may also inquire. Suppose the CLA is not satisfied with the application. In that case, it may reject the applications for test licenses, and the reasons for rejection must be submitted in writing within 30 days from the date of the application submission, as per rule 40 in sub-rule (2).

Conditions to Use & Reporting Requirement for Test License  

The Medical Device for which the test license for medical devices Import has been granted, as per sub-rule (1), is to be used only for clinical investigation, test, training, etc., and such clinical investigation, test, training, etc. is supposed to be carried only at the premises which are mentioned in the test license. Suppose the Medical device is taken to any place other than the one mentioned in the test license. In that case, the Central Licensing Authority should be informed in writing before taking action.

Record-Keeping Requirements for Test License

The holder of a test license is needed to maintain a record of all the activities undertaken, along with the manufacturer’s name, import date, and the quantity imported.

Invoice Requirements for Medical Device Import

During the Import, the Medical Device shall include the invoice, which contains information such as the name and amount of the medical device.

Validity & Expiration of Test Liense for Import

The validity period of the test license for Import will be three years from the date of Issue; after the validity period, it will be canceled.

Export or Destruction of Unused In-Vitro Diagnostic Devices

The medical devices with in-vitro diagnostic medical devices, as mentioned in sub-rule (2), are not being used. Still, after informing the Central Licensing Authority, they may be allowed to be exported or destroyed.

Show Cause Notice for Rule Violations

The Central Licensing Authority can issue a show cause notice to any licensee if he is found to be violating any rules, asking the licensee why his license must not be canceled.

Opportunity for Defense and Documentation of License Cancellation

The licensee is provided with an opportunity to explain in writing the reasons in his defense. If the Central Licensing Authority passes an order for cancellation of the license or otherwise, record the passing reasons for the said order.

Appeal Process for Canceled Test License 

A licensee whose testing license has been canceled by the Central Licensing Authority may file an appeal to the Central Government within 45 days from the order date.

Also Check These Latest Blogs:-

• What is a Form 44 in CDSCO?
• What is EPR Annual Compliance?

Eligibility For Obtaining Test License For Import

Any manufacturer or importer can apply for the test license for Import by Form MD-16 if he wants to import a small quantity of Class A, B, C, or D devices to India. They must submit the necessary documents and required fees. The test license is used for clinical investigation, testing, training, and testing medical devices—the Central Licensing Authority grants test licenses for medical devices through form MD-17.

What is the Validity of a Test License for Medical Devices Imported?

The validity of a test license for medical devices Import is 3 to three years from the date of its issuance.

What Is The Test License For Medical Devices Import Fee?

The test license for medical devices import fee varies according to the changes in the process. It suggested connecting with the expert regulatory consultancy in India to get the latest update on the payment.

What Is The Timeline To Get MD 17 From CDSCO?

It takes approximately 30 working days to get MD 17 from CDSCO.

Conclusion

There is continuous development in the Import of medical devices, which is 41%, or about 63,000 Rs. Currently, medical devices are in high demand in India and are regulated by the CDSCO to provide better service and transparency. To obtain a license or permission to import or manufacture medical devices in India, Importers must comply with the CDSCO regulations. However, because of the long and complex system of getting a license, many manufacturers or importers find the entire process extremely confusing and time-consuming. There are many challenges in some complex regulatory processes, such as reimbursement restrictions. The process’s complexity is why getting legal aid and support is necessary to obtain a test license to import medical devices.