CDSCO Medical Device Import License Renewal

The Medical Device Rule of 2017 stipulates that the medical device import license in India must be renewed every five years from the date of its issuance. For those manufacturers and importers who obtained their medical device import license in 2018 during the initial phase of the Medical Device Rule’s implementation, their licenses are scheduled to expire in 2023. This article will take you through the process of renewing the CDSCO medical device import license and provide you with the necessary guidance.

Acquiring a CDSCO Medical Device Import License in India:

Obtaining a CDSCO medical device import license in India is a meticulous and time-consuming process that requires comprehensive documentation. To obtain the import license for your medical device, follow these essential steps: Step 1: Register yourself on the Sugam Portal. Step 2: Pay the fee prescribed by CDSCO. Step 3: Submit the online application in Form MD-14 with all the required documents. Step4: The Concerned Authority will review your application and supporting documents. If everything is found to be satisfactory, they will issue an import license in MD Form-15.

For more detailed information on the registration and medical device import license acquisition process in India, you can read our blog titled “The Complete Guide to CDSCO Medical Device Registration.”

Understanding the Validity and Renewal Process:

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

The license holder is required to pay the retention fee for each overseas manufacturing site and each licensed medical device before every five years from the date of issuance. If the payment is not made within the specified timeframe, there is an additional 90-day grace period to pay, but with a late fee of two percent per month. Failure to pay the retention fee within this extended period results in the license being considered cancelled.

Renewing the medical device import license involves two steps:

Paying the retention fee.
Submitting the updated documents.

Documents Required for Medical Device Import License Renewal:

For the renewal of CDSCO medical device import license, the following documents are necessary:

Covering letter stating the purpose of the application • Details of the Base license and endorsement license, if any. • List of products to be removed (if applicable) along with reasons for removal • Breakup of the requisite fees based on the product class and manufacturing sites • An undertaking by the manufacturer, confirming no change in Device Master File (DMF) and Plant Master File (PMF). • Post-marketing surveillance data (Vigilance reporting) from the last 5 years • Valid Free Sale Certificate/Marketing Authorization from the country of origin (if any) and from any of the following countries: USA, EU, UK, Canada, Japan, Australia. • Sales data of each device in India during the last 5 years. • Valid copies of Quality Certificate ISO 13485 and applicable EC design certificates • An undertaking by the manufacturer and authorized agent, stating their agreement for further retention of the Import License • Details of any Post Approval Change Application, if applicable.

Import License Retention Fee:

The retention fees for the import license vary depending on the type and class of the medical device. Here’s a breakdown of the retention fees:

Conclusion:

Renewing your medical device import license is crucial to comply with the requirements of the Medical Device Rule of 2017. The renewal process involves paying the retention fee and submitting the updated documents. Regulatory Solutions India can assist you with the renewal process and ensure that your license remains valid. Contact us today to learn more about our services and discover how we can support you in meeting your regulatory requirements.