“Manufacturers will need to provide updated documentation, including the ISO 13485 certificate, Free Sale Certificate (FSC), and other updated documents, in order to complete the retention process.”
Gunjan Verma
Managing Partner
Asia Actual India
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India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses
Published on: March 24th, 2023
Updated: August 28, 2024
India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year (after the 5-year validity period). The update includes important information on retention fees and required documents.
Please contact Asia Actual here if you have any questions regarding this recent update to the CDSCO import license retention process, or if you require support in the renewal process.
Steps to Renew Medical Device Import Licenses from India’s CDSCO
Outlined in the Medical Device Rules, 2017, manufacturers must renew their Import License(s) every five (5) years to retain market access in India. Given that the Medical Devices Rules, 2017, were implemented in 2018, the first round of Import Licenses approved under the new rules are set to expire later in 2023, this year.
Renewing an Import License includes two steps; (1) paying the retention fees and (2) submitting the updated documents. Import licenses obtained for manufacturing sites and medical devices are valid in perpetuity as long as the retention fees are paid and updated documents are submitted every five years. The list of retention fees and documents can be found below.
Import License Retention Fees in India
Manufacturers seeking to retain market access will need to pay Retention fees every 5 years for each Import License (manufacturing site) and each Endorsement (product registration). These fees range from US$50 for a Class A device to US$3,000 for Class D Import License and are the same as the initial application’s fee.
The fees, specified in the Second Schedule of MDR 2017, apply to each overseas manufacturing site and each approved medical device is endorsed to the license.
The initial application, and retention fees, are as follows:
| CLASSIFICATION TYPE | Import License / PLANT MASTER FILE | Endorsement / DEVICE MASTER FILE |
| Class A Medical Device | US$1,000 | US$50 |
| Class B Medical Device | US$2,000 | US$1,000 |
| Class C Medical Device | US$3,000 | US$1,500 |
| Class D Medical Device | US$3,000 | US$1,500 |
| Class A in-Vitro Diagnostic | US$1,000 | US$50 |
| Class B in-Vitro Diagnostic | US$1,000 | US$50 |
| Class C in-Vitro Diagnostic | US$3,000 | US$500 |
| Class D in-Vitro Diagnostic | US$3,000 | US$500 |
Renewing Endorsements
It is important to note that retention fees are due every 5 years from the date for which the specific Base License was originally approved and not dependent on when the Endorsement was approved.
Earlier, after discussions and seeking guidance from the CDSCO PRO cell, it was understood that the Base Import License and its subsequent Endorsements would be subject to a retention fee submission after 5 years from the date of approval, with no requirement to link the base license to subsequent endorsements.
However, during the recent MedTech Expo 2023, we had the opportunity to clarify this with Mr. Aseem Sahu, Deputy Drugs Controller India (DDCI) of the CDSCO Medical Device Division. Mr. Sahu confirmed that both the Base Import License and all related Endorsements must be applied for retention at the same time, specifically 5 years from the issuance date of the Base Import License, rather than from the issuance date of each individual Endorsement approval.
This new requirement may pose challenging for manufacturers, particularly in cases where Endorsements are issued close to the 5-year mark of the Base Import License.
Documentation Requirements for India Retention
The CDSCO MD’s Online checklist mandates submission of the following documents and information as part of the process for the retention of import licenses:
- Application and intention forms,
- Copy of all licenses, approvals, and endorsements related to the MD-15 Import License,
- List of products being removed from the license (if applicable),
- Declaration from the manufacturer confirming there are no changes,
- Sales data by product,
- Post market surveillance reports,
- Free Sale Certificate from National Regulatory Authority of country of origin and following six reference countries: USA, EU, UK, Canada, Japan, Australia – both are required.
- Updates ISO 13485 certificate,
- Copy of any post approval changes,
- Additional information,
- Retention fees based on manufacturing site and individual products listed.
Manufacturers will want to ensure the they possess the above documentation in order to successfully renew their import license. A Retention Certificate will be issued once the retention fee is paid and the documents submitted online are reviewed and approved by CDSCO.
Amendments: The system does not allow for amendments during the renewal and updates to the product will need to be made separately. The renewal process requires a declaration from the manufacturer that no changes have been made to the product or manufacturing process. Manufacturers should be vigilant with license maintenance in India in order to avoid complications and delays in the license renewal process, which could interrupt market access.
Late Fees: Retention fees are to be submitted for maintenance of the perpetual import licenses. The fees can be paid after the renewal date but will incur a late fee.
Come Grow With Us
Please contact us if you need more information on import license renewal in India. Asia Actual has an office in India located in Delhi staffed by experienced, bilingual regulatory and commercial professionals that will address any questions or provide support.
Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through device registration, independent license holding, direct fulfilment, and a variety of sales channel support services.
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