Are you the one who is willing to apply for the test import license in India then must understand the MD 16 and 17 form. 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 MD 16 and MD-17 Form. 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.

Definition Of MD 16 and 17 Form

MD 16 Form – It is an application for the license to import medical devices. It is required for clinical investigations or test evaluation or Demonstration or Training.

MD 17 Form – The MD 17 form is required for all individuals who are willing to import small quantities of medical devices Class A, Class B, Class C, or Class D.

Who Can Apply for MD 16 and 17 Form?

Anyone willing to import medical devices in India can apply for the MD 16 and 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 and 17 Form?

When you apply for the medical device import license then you fill out the application of MD 16 and 17 forms as per the CDSCO guidelines. The MD 16 is used to apply for the registration of import test license and MD 17 is to grant the certificate for the regulation of medical products in India. 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 Documents are Required for MD 16 and 17 Form Application?

When you fill out the application form for MD 16 & 17 you have to attach a few mandatory documents. Without these documents attached, you are not allowed to apply for the registration and license grant. So, attach all the mentioned documents:

• 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 MD 16 & 17 Form Application Cost?

MD 16 and 17 forms for medical device registration vary due to the device classification and risk of the equipment. Due to the classification of medical devices Class A, Class B, Class C & Class D application fee is different. You must consult with the experts in medical device registration before filing a form.

What is the Validity of MD 16 and 17 Form?

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 and 17 Form

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.

Points To Be Consider While Filling MD 16 and 17 Form

When you fill an application you must consider all the points. If you miss any of the points then your application must be cancelled or rejected.

• 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.

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