Apply for Medical Device Registration in Maharashtra

Medical devices in India are regulated under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017. Depending on the device and activity, the applicable process may involve manufacturing or import licensing and related regulatory approvals.

CDSCO describes four risk classes: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk) and Class D (high risk).

For the applicable import pathway, CDSCO identifies Form MD-14 for an import-licence application and MD-15 for the resulting import licence. The precise supporting documents depend on the device and applicant.

Yes, where the device and activity fall within the manufacturing licensing framework under the Medical Devices Rules, 2017. The required form and authority depend on the risk class and application type.

Quality-system requirements depend on the applicable regulatory pathway, device class and manufacturing activity. The application should be prepared against the current CDSCO checklist for the specific route.

Medical-device regulation is governed nationally under the applicable central framework, while State Drug Control authorities may have roles in specified licensing and regulatory activities. The correct authority depends on the device and application pathway.

Yes. We can assist with regulatory pathway assessment, classification review, document preparation, application support and responses to regulatory queries.

No. Applications remain subject to scrutiny and approval by the competent regulatory authority. Submission of an application does not itself guarantee a licence or registration.