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FAQs for subsequent importer license of medical devices in India

On September 15, 2025, the Central Drugs Standards Control Organization (“CDSCO”) which issues import license for medical devices and In-vitro diagnostic medical devices (“IVD”) in India, announced that it had introduced a new regulatory pathway for importers of medical devices which are already approved for marketing in India. Such importers may obtain license as a ‘subsequent importer’ by submitting limited set of information and documents as opposed to the original importers who received the first import license for import of specific medical device in India.
After the announcement, several questions and issues remain arose, which are yet to be addressed by CDSCO. In this article, we have attempted to collate the questions and issues in form of frequently asked questions (FAQs) and address them to the best of our current understanding.
Please note that our answers are based on our good faith understanding of the current law and industry practice and should not be construed as official responses of CDSCO or professional advice.

1. Who qualifies as a “Subsequent Importer”?
Any entity/person who intends to import into India a medical device or IVDS that is already licensed by the CDSCO under the Medical Devices Rules, 2017 (MDR) to be imported into India by another importer, may apply as a subsequent importer.

2. Who cannot be a subsequent importer in India?
Importers of medical devices which are not already licensed to be imported into India, and importers who do not have direct access to foreign manufacturer of the medical device sought to be imported, cannot become subsequent importers in India.

3. Is there a similar regulatory pathway available for subsequent manufacturers of medical devices?
No. Unlike the concept of a subsequent importer, there is no provision that allows an entity in India to act as a subsequent manufacturer. Domestic manufacturers who are desirous of claiming the title of ‘manufacturer’ without manufacturing the medical device may explore the loan license route.

4. Where should applications to obtain a license as a Subsequent Importer be submitted?
The application for obtaining a license as a subsequent importer has to be filed through the CDSCO MD online portal.

5. In which form is the application for obtaining a license as a subsequent importer to be filed?
The application will be submitted in Form MD-14. The license will be issued in Form MD-15.

6. Is the subsequent importer route available to importers of IVDs?
Yes. The subsequent importer route is available to both importers of medical devices and IVD.

7. Is a wholesale drug license prerequisite for applying for a subsequent importer license?
In order to import and sell medical devices in India, the applicant who wishes to obtain subsequent importer license must first obtain wholesale drug License or registration certificate under Form MD-42.

8. Is submission of a fresh Power of Attorney (POA) required for subsequent importer application?
Yes. A fresh POA has to be submitted at the time of application.

9. What is the role of foreign manufacturer in obtaining subsequent importer license?
The person making an application for obtaining a license as subsequent importer has to obtain original documents from foreign manufacturer. The documents include POA, labels, regulatory certificates like free sales certificate, quality management certificate, undertaking etc.

10. Does an applicant have to submit Plant Master File (PMF) and Device Master File (DMF) for obtaining subsequent importer license?
No. There is no requirement to submit the actual PMF and DMF. However, the foreign manufacturer is required to submit an undertaking confirming that there have been no major changes to the PMF and DMF of the previously approved device since its primary submission and approval.

11. Is it mandatory for the subsequent import license holder to comply with the labelling requirements prescribed under MDR?
Yes. The subsequent importer has the mandatory obligation to comply with the labelling requirements prescribed under the rules.

12. Is a separate government fee payable for obtaining a subsequent importer license?
Yes. The applicant is required to pay both manufacturing site fee and product fee to obtain a fresh license as a subsequent importer.

13. What are the timelines for obtaining a subsequent importer license?
The Medical Devices Rules, 2017 do not prescribe specific timelines for obtaining a subsequent importer licence. The typical timelines to obtain an import license under Form MD-14 is nine months from the date of application. In practice, the timeline for obtaining a subsequent importer license may be similar or shorter than the primary import license, since the approval relies on the primary import licence already granted for the same device.

14. What is the validity of a subsequent importer license?
There is no clarity on it. However, in our view, the license for the applied device should be valid in perpetuity as long as the primary license stands.

15. Will the subsequent importer license remain valid if the primary import license is suspended or cancelled?
There is no clarity on it. However, in our view, if the primary import licence is suspended or cancelled due to issue with the medical device or foreign manufacturer, all subsequent importer licences linked to that device should be suspended or cancelled.

16. Does the applicant have to submit predicate analysis document for obtaining a subsequent importer license?
No. There is no requirement to submit the predicate analysis document at the time of application because the license as a subsequent importer is issued based on an already approved license.

17. Can a subsequent importer file an application for addition of models for the already approved device?
There is no clarity on it. However, in our view, the licensee should be able to add models.

18. What is the process to renew the subsequent importer license?
The license issued in Form MD-15 is valid in perpetuity. However, the subsequent impoter is required to pay the retention fee every 5 years from the date of its issuance in order to retain the license.

19. Can a person obtain a subsequent importer license for brand names different from those approved under the primary import license?
No. The subsequent import license can be issued only under the brand names approved in the primary license.

20. Does a subsequent importer have the responsibility to report the adverse events?
Yes. The subsequent importer has to report every adverse event to the authorities.

21. Does the subsequent importer have to comply with BIS standards?
Yes. All medical devices imported and sold in India shall conform to the standards laid down by the BIS, which are periodically notified by the Ministry of Health and Family Welfare (the Ministry). Where no such relevant standard of any medical device has been laid down either by BIS or by the Ministry, such device shall conform to the standards laid down by the International Organisation for Standardisation (ISO) or the International ElectroTechnical Commission (IEC), or by any other pharmacopeial standards. In case none of the above-mentioned standards exists, the device shall conform to the validated manufacturer’s standards.

22. Does subsequent importer have to fulfil the obligations prescribed under Drugs Price Control Order, 2013 (DPCO)?
Yes. The licensee has to comply with the obligations of declaring Maximum Retail Price (MRP) on the package of the device if the device is sold in retail packages. The licensee has to ensure that the MRP of the device is less than the prescribed price ceiling, where applicable, or does not increase beyond 10% in any 12-month period.

23. Is it mandatory for a subsequent importer to obtain IPDMS registration with National Pharmaceutical Pricing Authority (NPPA) under DPCO?
Yes. The licensee has to mandatorily obtain registration on IPDMS portal and file mandatory forms prescribed under DPCO.

24. Does the subsequent importer obliged to comply with Legal metrology (prepackaged commodities) rules, 2011 (LMPC Rules)?
Yes. The licensee has to obtain a registration under LMPC Rules and comply with the labelling requirements prescribed under the rules.

25. Is the subsequent importer required to fulfil the obligations under Plastic, E-waste and Battery Waste Management Rules?
Yes. The subsequent importer must comply with the Plastic, E-waste, and Battery Waste Management Rules where applicable. If the approved device is an electronic medical device, or it is an electronic medical device containing battery, and is imported with plastic packaging material, the importer must obtain the required Extended Producer Responsibility (EPR) registrations under the respective rules and fulfil all associated compliance obligations.

26. Can a subsequent importer transfer its license and rights to the third party?
No. The license issued in Form MD-15 is non-transferable.

27. Can an entity become a subsequent importer for Class A Non-sterile Non-measuring (NSNM) medical device?
No. The fresh registration under Class A NSNM category has to be obtained.

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.

1. India’s Central Drug regulator, the Central Drugs Standards Control Organization (CDSCO) has issued an instruction manual for manufacturers and importers of devices not having predicate devices, to file Periodic Safety Update Report on the Medical Device Portal.
Source: bit.ly/4g5ORaV

2. India’s Delhi High Court held in a recent order that petitions regarding patent infringement, during the lifetime of a patent will continue to be valid even after the expiry of the term of the patent itself, since the cause of action has arisen at a time when the patent was still active.
Source: bit.ly/3PL3TYU

3. India’s central level regulator of the medical profession and education, the National Medical Commission has issued a draft Teachers’ Eligibility Qualifications, where it is proposed to permit non-medical personnel with Masters and PhD level degrees to teach Anatomy, Physiology and Biochemistry at medical educational institutions.
Source: bit.ly/40HAW6o

4. A premier commercial body of India’s restaurant business operators are currently mulling legal action against quick-commerce companies which have created a business model of undercutting the restaurant business through the use of private-label food products.
Source: bit.ly/4auFgsV

5. The European Pharmacopoeia has adopted three general standards for mRNA based vaccines, (1 mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, (2) mRNA substances for the production of mRNA vaccines for human use, and (3) NA templates for the preparation of mRNA substances. These standards are expected to set a framework of control for regulatory control and approval of mRNA vaccines across the EU and all jurisdictions that accept EU Pharmacopoeia standards.
Source: bit.ly/4ar8HMK

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Timelines for obtaining import license for medical devices including IVD’s in India

The import of medical devices including in-vitro medical devices (hereinafter referred to as “medical devices”) in India is regulated by India’s central medical device regulator, the Central Drugs Standard Control Organization (CDSCO). In order to import a medical device into India, the importer has to make an application for import license Form MD-14 of Medical Devices Rules, 2017 (MDR, 2017) before CDSCO. Once the application is processed successfully, the CDSCO grants an import license to the importer in Form MD-15 of MDR, 2017.

Since 1st April 2020, all medical devices (including its accessories and components) are regulated as drugs in India. An import license has been made mandatory to import medical devices depending on its risk classification from the following dates:

  • For Class A and Class B medical devices: 1st October 2022
  • For Class C and Class D medical devices: 1st October 2023

In the paragraphs below, we have answered some of the common questions regarding timelines for obtaining import license for medical devices on the basis of our working knowledge of the law and prevailing practice.

1.  What is the usual time within which an import licence may be granted by CDSCO?

The prescribed timeline for issuance of import license is nine (09) months from the date of application. However, the timeline is suspended if a query on the application is raised by CDSCO.

2. What is the approximate timeline for receiving query from CDSCO on the import license application?

As per current estimate, a query is typically received within a span of 3-4 months from the date of import license application. Please note that CDSCO may raise multiple rounds of queries.

3. How much time does an applicant of import license gets to reply to the queries?

The general expectation of CDSCO is that the queries should be responded within forty-five days from the date of receipt of queries.

4. What happens if a query cannot be responded within 45 days?

If the applicant is facing a difficulty in replying to the query, an intimation may be sent to CDSCO justifying the reason for delay and providing appropriate undertaking.

5. What is the maximum time within which queries have to be responded?

There is no official time limit for responding to the queries which has been stipulated by CDSCO. However, the expectation is to respond to the queries within the reasonable time frame.

6. What is the timeline by which the response to the queries is processed by CSDCO?

There is no prescribed timeline for processing the queries by CDSCO. However, the timeline for grant of import licence is nine (09) months from the date of filing of the application.

7. Is the time taken by the authorities to grant an import licence includes the time taken by the importer to respond to the queries?

No. The total timeline of nine months prescribed for grant of import license is not inclusive of the time taken by the importer to respond to the queries.

8. What is the time limit in which the importer can appeal to the Central Government in case the application is rejected by CSDCO?

If the application is rejected by CDSCO, the applicant may appeal to the Secretary, Ministry of Health and Family Welfare within a period of forty-five days. The Secretary or another officer designated by the Secretary may, after conducting an enquiry into the matter as considered necessary, pass orders in relation to the appeal within a period of ninety days from the date of appeal.

9. What is the validity of import license granted in Form MD-15?

The licence granted by CDSCO under Form MD-15 is valid in perpetuity unless cancelled or surrendered. The validity of the license so granted is subject to the payment of the retention fee by the importer.

10. When is importer license retention fee due to be paid?

The retention fee to retain import license has to be paid by the importer every 5 years.

11. What if the importer of medical device fails to pay the retention fee within the prescribed time period?

If the import licence holder fails to pay the required retention fee on or before the prescribed due date, the license holder is required to pay a late fee in addition to the retention fee.

The late fee will be calculated at the rate of two per cent (2%) of the import license retention fee for every month or part thereof within ninety days. Non-payment of fee until expiry of ninety days will result in cancellation of the import license.

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