CDSCO has issued essential guidance on retention of import license in India. This process is coming into effect under the new rules, as the first round of import licenses issued will start to expire this year (after the 5-year validity period). The update includes essential information on required documents and retention fees. 

How do you obtain a CDSCO Import License for medical devices in India?

Obtaining a CDSCO medical device import license in India involves a time-consuming and meticulous process that entails comprehensive documentation. The following essential steps are used to get the import license for your medical device:

• Step 1: On the Sugam Portal, register yourself.
• Step 2: Pay the CDSCO-prescribed fee.
• Step 3: Submit an online application on Form MD-14 with the required documents.
• Step 4: Your application and support are reviewed by the concerned authority. They will issue an import license in MD Form 15 if it is satisfactory.

Understanding the Validity and Renewal Process:

According to the MD Rule of 2017, the import license remains valid perpetually unless voluntarily surrendered or cancelled. The license holder should pay the retention fee and submit updated documents to the Central Drugs Standard Control Organization (CDSCO) to ensure ongoing validity. The government agency is responsible for regulating medical devices in India.

For each overseas manufacturing site and licensed medical device, the license holder must pay this fee every five years from the date of issuance. If it is not paid within the specified timeframe, there are an extra 90 days to pay, albeit with a monthly two per cent late fee. If failure to pay the retention fee within the given period results in the license being considered cancelled,

Retention of Import License in India requires two steps:

1. Pay the retention fee.

2. Submit the updated documents.

Documents Needed for Retention of Import License in India:

For retention of Import License in India, the following documents are required:

• I am writing a letter for an application.
• Base license and endorsement license details, if any.
• Products list that are to be removed (if applicable) with reasons.
• Requisite fees are broken up based on the product class and manufacturing sites.
• An undertaking by that manufacturer that there is no change in the plant master file (PMF) or device master file (DMF).
• Last five years post-marketing surveillance data (vigilance reporting).
• Valid Free Sale Certificate or Marketing Authorization from the country of origin (if any) and from the following countries: USA, EU, UK, Canada, Japan, and Australia.
• Sales data for each device in India during the last five years.
• A valid copy of Quality Certificate ISO 13485 and applicable EC design certificates.
• An undertaking by the authorized agent and manufacturer stating that they agreed upon further renewal of the import license.
• Post Approval: Change the application details, if any.

Manufacturers must possess the above documentation to renew their import license successfully. Once the retention fee is paid, a retention certificate will be issued, and the documents submitted online will be reviewed and approved by the CDSCO.

Amendments: During the renewal, the system does not allow for amendments, 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 manufacturing process or the product. To avoid complications and delays in the license renewal process, manufacturers should be vigilant with license maintenance in India, which interrupts market access.

Late Fees: For maintenance of the perpetual import licenses, retention fees are to be submitted. The costs can be paid after the renewal date, but a late fee will be incurred.

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Retention of Import License in India Fees

For each import license (manufacturing site) and each endorsement (product registration), manufacturers seeking to retain market access must pay retention fees every five years. These fees range from US$50 for a low-risk device to US$3,000 for a high-risk device import license and are similar to the initial application fee.

The fees specified in the Second Schedule of Medical Device Rules 2017 apply to each overseas manufacturing site, and each approved device is endorsed to the license.

The retention fees and initial application are as follows:

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Classification type	Import License / Plant Master File	Endorsement or 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

It is essential to note that retention fees are due every five years from the date the endorsement or specific import license was initially approved. By the classification of the manufacturing site or the classification of the product, the fee will remain the same amount as the original fee.

Conclusion:

To comply with the requirements of the Medical Device Rule of 2017, Retention of the CDSCO Import License is crucial. The renewal process includes paying the retention fee and submitting the updated documents.