Top FAQs on CDSCO Medical Device Registration Answered

1. Who can register on CDSCO online portal?

Following users can register on CDSCO online portal:

·       Importer

·       Indian Agent

·       Foreign Enterprise holding Indian Subsidiary

·       Corporate

2.  Can one application cover multiple manufacturing sites as per medical device import CDSCO regulations?

No. We need to submit a separate Form MD-15 with fees and documents for each site.
A separate application, along with requisite fees and documents, is required for each actual manufacturing site, as outlined in medical device import CDSCO regulations.

3.  Can an authorized agent include their brand name in Form MD-14 for a CDSCO import license for medical devices?

Yes, if the brand name appears on the Free Sale Certificate of an approved reference market; otherwise, state “Not Applicable.” The brand name must be listed in the FSC issued to the legal manufacturer. If not, “Not Applicable” should be entered in Form MD-14.

4.  What is considered as “Change of constitution” of the company under the MDR 2017?

The Change of constitution is defined under Rule 3(j) of MDR-2017 as under: o a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa; of a company means-

(A) its conversion from a private to a public company, or from a public to a private company; or

(B) any change in the ownership of shares of more than fifty per cent. Of the voting capital in the body corporate or in case of a body corporate not having a share capital, any change in its membership; and where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change in the constitution of that other body corporate within the meaning of this clause;

5.  In case of Change of constitution of the company whether fresh license is required?

Yes, the applicant shall inform to the Licensing Authority about such change within 45 days and apply under MDR-2017 within a period of 180 days from the date of such change in constitution.]

6.  What is a Neutral Code in CDSCO medical device registration?

A Neutral Code is an identification code assigned by CDSCO to a medical device that does not yet have an established registration number under a specific importer or manufacturer. It is typically used when multiple importers or distributors are involved, allowing different entities to import the same device model from the same foreign manufacturer without duplicating the registration process.

Neutral Codes help streamline tracking and ensure uniformity in product identification across different importers handling the same approved device.

7.  Who can apply for a Neutral Code under CDSCO?

A Neutral Code can be applied for by an importer or manufacturer’s authorized representative in India when the medical device is identical in all technical and quality aspects to an already registered device but is being imported or marketed under a different brand name, distributor, or importer.

In other words:

·       The foreign manufacturer (through its Authorized Indian Representative) or

·       A licensed importer of the same manufacturer

can apply for a neutral code to ensure regulatory traceability of the same device model across multiple importers or branding arrangements.

This process avoids duplicate evaluation of identical devices and helps CDSCO maintain consistent control and identification while allowing more than one importer to market the same approved product.

8.  Who is a Subsequent Importer under CDSCO regulations?

A Subsequent Importer is an additional importer who wishes to import a medical device that is already registered or licensed in India by the original (primary) importer for the same foreign manufacturer.

The subsequent importer must submit a separate application to CDSCO, referencing the primary importer’s registration/license, and obtain their own Import License (Form MD-15) before importing. This ensures that all importers maintain individual accountability for compliance, quality, and post-market surveillance obligations.

9.  Is a No Objection Certificate (NOC) from the Department of Animal Husbandry and Dairying (DAHD) required for all veterinary medical devices before licensing?

No. The NOC from DAHD is applicable only in cases where a veterinary medical device does not have a previously approved predicate device.

10.  Does changing the sterilization method make it a different device?

Yes. The existing license must be updated with an endorsement to reflect the change as per MDR, 2017.