13Aug

How to Obtain a CDSCO Medical Device Import License in India?

Acquiring a CDSCO medical device import license in India involves a meticulous and time-consuming process that entails comprehensive documentation. Follow these essential steps to obtain the import license for your medical device:
Step 1: Register yourself on Sugam Portal.
Step 2: Pay the fee prescribed by CDSCO.
Step 3: Submit online application in Form MD-14 with the required documents.
Step 4: The Concerned Authority will review your application and supporting documents. If found satisfactory, they will issue an import license in MD Form-15.

According to the Medical Device Rule of 2017, the import license remains valid perpetually unless 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), the government agency responsible for regulating medical devices in India.

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

Renewing the medical device import license requires two steps:
1. Pay the retention fee.
2. Submit the updated documents.

Documents Required for Medical Device Import License Renewal:

The following documents are required for CDSCO medical device import license renewal:

1. Covering letter with purpose of application.
2. Details of Base license and endorsement license, if any.
3. List of products to be removed (if applicable) with reasons.
4. Requisite Fees breakup basis the product class and manufacturing sites.
5. An undertaking by the manufacturer, that there is no change in Device master file (DMF) and Plant master file (PMF).
6. Post marketing surveillance data (Vigilance reporting) during last 5 yrs.
7. Valid Free Sale Certificate/Marketing Authorization from the country of origin (if any) and from any of the following countries viz USA, EU, UK, Canada, Japan, Australia.
8. Sales data of each device in India during last 5 yrs.
9. Valid copies of Quality Certificate ISO 13485 and applicable EC design certificates.
10. An undertaking by the manufacturer and authorized agent, stating that they are agreed for further retention of the Import License.
11. Details of Post Approval Change Application, If Any.

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