Medical Device CDSCO Import License for Testing Purpose: An Overview
In the rapidly evolving landscape of healthcare, importing medical devices for testing purposes in India necessitates adherence to stringent regulatory procedures. The Central Drugs Standard Control Organization (CDSCO) oversees the importation of medical devices and issues import licenses MD-16 to ensure compliance with safety and quality standards.
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Understanding the CDSCO Import License MD-16 and MD-17
Importers aiming to import Class A, B, C, or D medical devices into India can acquire an import license via approval of Form MD 17 issued by the CDSCO.
This license facilitates permission of importing the medical devices for:
- Testing
- Evaluation
- Training or
- Demonstration purpose within the country.
Form MD 16: For the above Form MD 16 is the application form utilized by applicants to apply.
Form MD 17: Form MD 17 is the approval issued by CDSCO as permission for importing medical devices for activities such as testing, evaluation, training, or conducting clinical investigation as specified in the license.
Process of Application:
To initiate the application process, applicants are required to utilize Form MD 16 via the Sugam online portal, which serves as the platform for regulatory submissions.
The step-by-step process for acquiring a test license for medical devices involves:
- Online registration on the Sugam portal.
- Formulating the online application with accurate details.
- Uploading the stipulated documents specified in Form MD 16 checklist.
- Facilitating the processing of fees mandated by the regulatory body.
- Submission of the completed application through the designated online portal.
A mandatory fee is applicable for obtaining the license to import medical devices for purposes such as testing, evaluation, training, or demonstration. Each medical device import requires a payment of 100 US dollars per device by the applicant.
Ensuring Compliance and Validity
Compliance is crucial throughout the application process:
- Quantity of medical devices and batch details must be specified.
- Clinical investigation protocols are mandatory for relevant imports.
- Precise testing/training locations need to be specified during application.
Upon issuance (within 30 working days) of Form MD 17, the test license remains valid for three years.
Seeking CDSCO Import Licenses for Testing Medical Devices in India?
Operon Strategist's Expert Help for Medical Device Testing in India
Are you seeking guidance or assistance in obtaining your CDSCO Import License for testing (form MD-16 and MD-17) for importing medical devices in India? We’re here to help! Contact us today for expert support and to streamline your application process.
Let’s navigate the regulatory landscape together and ensure a smooth pathway for your medical device imports. contact us on WhatsApp or Call on 09370283428
