The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
All Medical Devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or metabolic means, but which may assisted in its intended function by such means for one or more of the specific purpose of:-
- Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
- Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- Investigation, replacement or modification or support of the anatomy or of a physiological process;
- Supporting or sustaining life;
- Disinfection of Medical Devices
- Control of conception”
PROCEDURE FOR CDSCO REGISTRATION
Before applying for a CDSCO Certification of a medical product in India, it is recommended you carefully search the CDSCO announcements for specific information regarding your product first. The authority may additionally consult more detailed BIS Standards and decide based on those, whether a product shall be approved or not.
The manufacturer is not allowed to file the CDSCO approval application for import or even import his products by himself. Manufacturers are required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the authority CDSCO in India. This AIR must have a valid wholesale license to be eligible to apply for an import license.
For each product risk class (A, B, C, or D) there are different CDSCO accreditation application requirements for both the manufacturer and the importer.
The application will likely require certain application forms, manufacturer information, technical data sheets, ISO certificates, IFU, test reports, clinical data as well as the accreditation in the country of origin. All documents will need to be available in English.
It is up to the CDSCO to decide whether it wants to conduct an inspection of your factory. Generally, such an audit is required if your product is not yet approved in your own market. When this factory inspection should be done is different for each risk level.
In some cases the certification authorities also request for a personal technical presentation at the CDSCO to better understand the product. At this meeting a technical representative of the company as well as the Authorized Indian Representative (AIR) are required to appear in person.
New product types will undergo a review by the Subject Expert Committee (SEC) or could be put to further tests if it is a special innovation (new technology, new material, new application). Clinical data in India could also be requested ahead of CDSCO Approval
Products within risk class A can be imported immediately and only have to be tested within 4 months after the initial CDSCO registration. Products of risk classes B, C and D are required to be tested prior to import. If required, factory inspections for risk levels A & B can be done after approval and import, for risk levels C & D they however need to be done before. For products of risk class D, only the National Institute of Biologicals (NIB) in India is accredited to conduct tests.
For some in-vitro devices a test report from an appropriately accredited test lab in another large regulated market can be accepted.
After the successful completion of all steps of the CDSCO certification of medical products in India, the authority will issue an import license to all officially awarded AIRs. This license has to be renewed every five years.
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