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Medical Device Import License
& CDSCO Registration
Need MD 15 Import License?
ELT Corporate is here to help! Our experts simplify the process by providing guidance, compliance support, and free documentation review. Get your license hassle-free with our trusted regulatory expertise.
- Specialized Knowledge of MD 14/15 Guidelines
- Importer Registration Expedition
- MD Importer Registration for Retention
- MD Importer Registration Endorsement
- MD Importer Post Approval Changes
- MD Importer registration for samples
Overview CDSCO Medical Device Import License
The Central Drugs Standard Control Organization (CDSCO) is the main authority in India that ensures medical devices are safe, effective, and high-quality. To import medical devices into India, you need a CDSCO Medical Device Import License. This license guarantees that the devices meet strict CDSCO standards, helping protect public health and ensuring only top-quality products are sold in India.
Form MD 14: It is an application form to get a license to import medical devices of class A, B, C or D.
MD 15 License: It is a license form that CDSCO grants to let people bring medical devices into India based on the classification A, B, C or D. MD 15 is a registration issued by the CDSCO for the importer to import medical devices into the country. It is mandatory for all devices that are related to the medical industry. MD 15 Import License is mandatory for all importers.
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Overview (IVD) In-Vitro Diagnostic Device Import License
An In Vitro Diagnostic (IVD) Device Import License is a regulatory authorization required for importing IVD medical devices in India. This IVD import license are issued by the Central Drugs Standard Control Organization (CDSCO). These devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health conditions, or check for infections. The licensing process make sure that the imported IVD medical devices meet the necessary quality standards and are safe for use. The license is provided by the CLA after reviewing the application along with required documents like GMP certification, CE certification, ISO certification, PMS report, and details of the authorized agent, among others.
Who Can Apply For Import Licence
Medical Device Wholesaler & Distributor
Wholesaler can apply for the importer licenses of medical devices under CDSCO regulations and approval process.
Medical Devices Manufacturer Licence
The manufacturer can apply for it for sale & distribution but must have Manufacturer License.
Authorized Medical Device Indian Agent
Under the CDSCO act authorized Indian agents can apply for the Medical Device Import License
What Are The Risk Classification Medical Device?
When you go for the registration you will find the various classes of medical devices. Each category of medical device have risk and here you will get to know about the classification of risk of Indian medical device for Importer Registration:-
Documents Required For MD 15 Licence
Validity For CDSCO Medical Device Import License
CDSCO Medical device Import licence is valid for 5 years (Class A, B, C & D). When the import licence expires, Importer has to renew his/her licence. For renewal there is no need for all documents, only old import licence and fee challan are required.
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