13Aug

Transitioning to Full Licensing: Class C and D Medical Devices in India

Full License Requirement for Class C and Class D non-notified medical device

It is important first to understand what is meant by a non-notified medical device. These are medical devices which have fallen under the ambit of the licensing regime after the adoption of the new enlarged definition for Medical Devices by Ministry of Health & Family Welfare in Feb 2020. (Not sure whether your device is non-notified or not? We can help)

This full license requirement deadline is the final step for transiting the Class C & Class D non-notified medical devices to the Licensing regime.  Currently, all class C and D non-notified medical devices are exempt from Manufacturing/Import licence and can be manufactured/ imported into India basis their mandatory registration with CDSCO. From October 1, 2023, for such devices, it will compulsory to have a license if you want to introduce your medical device in India.

For medical device importers:

Getting a CDSCO medical device import license in India can take up to six months post the submission of application. The preparation for the application submission is also a time-consuming process and can easily take 1-3 months depending on the level of preparedness of an organization. Hence, it is important that all Class C and Class D non-medical device importers apply for the import license at the earliest to avoid any business disruption post 1st Oct 23.

For medical device manufacturers:

Similarly, obtaining a medical device manufacturing license in India is a time consuming process involving not only the extensive documentation but also an inspection by a Medical Device Officers of the Central Licensing Authority (CLA) within 60 days of application submission. Hence, if you have not started the application process, there is an urgency to do so now to maintain business continuity.

Conclusion:

The transition from mandatory registration to manufacturing/import license for Class C and D non-notified medical devices is the final step towards the full licensing regime for such devices. Manufacturers/importers need to be aware of the new regulation and take proactive steps to obtain a manufacturing/ import license. Given that CDSCO can take up to 6 months to issue a license there is an urgent need for impacted importers/manufacturers to start their application process immediately, if not done till now. Timely compliance will not only avoid disruption in the supply chain but also ensure continued access to these medical devices for patients.

13Aug

Understanding the Validity and Renewal of CDSCO Medical Device Import License

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.