What is MD 16 & 17? Documents & Process

MD 16

The Central Drugs Standard Control Organization (CDSCO) issued a notification that selects many medical equipment that may be imported into India. Devices classified as Class A, Class B, Class C, or Class D are imported into India in limited numbers under a Test License in Form MD 16 & MD-17. These gadgets are imported for clinical research, testing, assessment, demonstration, or teaching.

To receive a Test license on Form MD-17 and import the equipment mentioned above, apply for an import license for testing, evaluation, demonstration, or training. The application for an import license should be submitted to the Central Licensing Authority in Form MD-16 via a designated online portal of the Ministry of Health and Family Welfare.

Who Can Apply for MD 16 & 17 Form?

Anyone willing to import medical devices in India can apply for the MD 16 & 17 license. This is necessary for the import. If you import your medical device without a certificate then you must be penalised.

How to Apply for MD 16 & 17 Form?

Follow these easy steps when you are applying for MD 16 & 17:-

  1. Register applicants on the SUGAM portal.
  2. Draft the Application.
  3. Upload all required Documents as per MD 16 & 17 Form.
  4. Pay the Fees
  5. Now submit the Application on the portal

Also Read – Form MD 14 in CDSCO

What are the Required Documents for MD 16 & 17?

All the documents are mentioned below:-

  • The name of the location where testing, assessment, demonstration, or training will take place
  • The procedure of clinical trials if the test license is necessary for clinical study.
  • A description of the medical equipment, including the material of manufacture, design label, intended use, and directions for usage.
  • A record of all dates and quantities of imported medical devices, as well as the name of the producer.
  • A record of an invoice or statement that contains data about the name and amount of medical devices imported 

How Much Does It Cost When Applying for MD 16 & 17 Forms?

MD 16 & 17 cost varies according to updation in the process and a few other things so it’s better to talk with a consultancy.

What is the Validity of MD 16 & 17

The MD 16 & 17 is valid for three years from the date of issuance. Always remember to renew your application before it expires. Otherwise, you have to again apply for this certificate from the start or you have to pay a penalty if anybody finds that your certificate is expired.

Timeline of Form MD 16 & 17

Most of the consultant claims that they will provide the MD 16 & 17 just in 6 and 7 days. But the actual timeline of MD 16 & 17 Form is about 2 – 3 months. It is a time-consuming process so, be aware of fake promises and go with the suggestions of experts.

Important Points

Keep in mind when applying for MD 16 & 17:-

  • The amount to be imported must be indicated and justified in the application to be filed.
  • Justification for The quantity to be imported must be properly prepared and include batch information, quantity to be used, and quantity to be retained.
  • The name of the location for testing, evaluation, demonstration, training, or clinical study is required and must be finalized and included in the application.
  • The name of the location for testing, evaluation, demonstration, training, or clinical study is required and must be finalized and included in the application.

Conclusion

To summarize, acquiring MD 16 & 17 forms is critical for importing medical equipment into India. The registration, document submission, and fee payment take place through the SUGAM site. These forms are valid for three years, with the opportunity to renew. Compliance with regulatory standards is critical, including the justification for import volumes and precise location information. License holders may appeal cancellations, and device relocation requires notice to the Central Licensing Authority. Multiple sites can be stated in a single application to provide flexibility. Overall, following protocols results in a seamless and compliant import process.

FAQ

When can the Licensee Appeal the Central Licensing Authority if the License is Cancelled?

License holders can appeal under 45 days to the Central Licensing Authority if their licenses are canceled.

How Can A Medical Device That Is Required To Be Taken To A Place Other Than That Mentioned In The Test License Be Relocated?

In this situation, the test licensee must notify the Central Licensing Authority in writing.

In Single Test License Application For Clinical Investigation, Testing, Evaluation, and Training, Is It Possible To Mention Multiple Sites?

Yes, it is possible to mention multiple sites if you are trying to add them to a single test license application for clinical investigation, evaluation, testing, and training.

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