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What is CDSCO Certification for India?

With a steadily growing medical market, India is an extremely lucrative destination for our customers. As in other areas, however, standards and precise regulations are only published piece by piece and every year new products are added or existing standards change, which makes it challenging to keep pace.
CDSCO approval is mandatory for medical devices in India.

Medical device manufacturers must apply to the CDSCO for regulatory approval (CDSCO Certification). This application should include information about the medical device, its uses, technical specifications, manufacturing processes and other relevant details.

Which products fall under CDSCO certification?

Medical devices as defined by CDSCO include the following categories:

Medical devices

This includes a wide range of devices used for diagnostic, therapeutic, or monitoring purposes, such as blood pressure monitors, heart monitors, ventilators, and surgical instruments.

Diagnostic Products

Diagnostic tools, laboratory equipment, and test kits for various medical tests may also fall under CDSCO registration.

Consumables

Medical consumables such as disposable syringes, catheters, bandages and sterile products may be subject to CDSCO certification.

Implants

Medical implants such as artificial joints, pacemakers, and other implantable devices may also fall under CDSCO registration.

Whether a product is subject to CDSCO approval is primarily determined by the CDSCO’s ad-hoc announcements. These are announced on the CDSCO website and currently comprise over 600 products. However, the very detailed standards of the BIS can be consulted for each application and, despite the absence of your product in the CDSCO announcements, the authority can still decide whether a product needs to be registered and tested or not. For CDSCO certification, correct application forms must be submitted as well as product approval in the domestic market by a local Authorized Indian Representative (AIR).

In India, medical devices are divided into 4 “risk levels” and regulated accordingly: from A as the lowest to D, the highest risk level. Only Level A rated products can be approved in India prior to extensive product testing.

Please also note that even after approval, the CDSCO is authorized to carry out so-called post-market surveillance. This means that the authority can request test reports or even test samples for tests in India at any time.

CDSCO Certification Process

Before submitting any application for the approval of medical devices in India, it is important to first search the CDSCO’s announcements for one’s own product. However, in each individual case, the authority can consult the very detailed standards of the BIS and decide for itself whether the respective product must be approved or not.

The manufacturer is not entitled to submit the application and to import his products himself. He is required to appoint an Indian Authorized Representative (AIR) as his representative. This AIR must have a trading license in order to apply for the import license.

Depending on the risk level of the product (A, B, C or D), there are different application requirements for the manufacturer and its importer.

The application documents include various forms, manufacturer information, technical data sheets, any existing ISO certificates, IFU, test reports, clinical data if applicable, as well as approval on the own market. All documents must be available in English.

In about a quarter of the applications, the authority requires a technical presentation in person to the CDSCO in order to understand the product in more detail. This meeting must be attended by a technical representative of the company and of AIR.

Risk level A products can be imported directly and must be tested within four months. Level B, C and D products must be tested before importation. For Level D, the National Institute of Biologicals (NIB) is accredited to perform testing.

For some in vitro devices, a test report from other major regulated markets may also be accepted.

Upon successful completion of all steps of CDSCO certification of medical devices in India, the authority issues an import license, which the company is allowed to issue to official AIRs subject to registration. This CDSCO license must be renewed every five years.

CDSCO Certification Change management

The CDSCO authority in India is very strict in distinguishing the registered products. Any difference between different versions or models of a product can lead to a classification of the product as a new product with different requirements for approval.

Special innovations that do not yet exist on the Indian market may be subject to increased scrutiny. Thus, tests or even a clinical investigation in India can be required, which must be applied for separately, both by the manufacturer and the importer, or both can be convened for a product presentation before the authority.

We will be happy to check whether the change to your product is such an innovation or whether a simple approval can be issued.