Medical Device Registration

Overview

Medical devices in India are regulated under the Medical Devices Rules, 2017, framed under the Drugs and Cosmetics Act, 1940, and administered by CDSCO. Devices are classified into Classes A, B, C and D based on risk, and manufacturers and importers require the appropriate registration, licence or import approval. Lower-risk devices are handled by State Licensing Authorities while higher-risk devices are handled by the Central Licensing Authority under CDSCO.

Objective

To obtain the registration or licence required to manufacture or import a medical device in India based on its risk class.

Characteristics

• Governed by the Medical Devices Rules, 2017 under the Drugs and Cosmetics Act, 1940
• Devices are classified as Class A, B, C or D by risk
• Lower-risk devices are handled by State authorities and higher-risk by the Central authority
• Applications are filed through the CDSCO online portal
• Separate approvals apply to manufacturing and to import

Eligibility

• Manufacturers of medical devices in India
• Importers and authorised agents of foreign medical devices
• Applicants able to meet quality management and technical file requirements
• Entities with an Indian presence or authorised Indian agent for imports

Governing law

• Medical Devices Rules, 2017
• Drugs and Cosmetics Act, 1940
• Central Drugs Standard Control Organisation (CDSCO) and State Licensing Authorities

The process

1. 1
   Classification

   We determine the risk class of your device and the correct licensing authority and route.

2. 2
   Technical file preparation

   We prepare the device master file, quality documentation and supporting records.

3. 3
   Application filing

   We file the application on the CDSCO portal with the applicable fees.

4. 4
   Query resolution and grant

   We handle queries and any audit requirements and follow up until the registration or licence is granted.

Documents required

• Device details, intended use and classification
• Device master file and plant master file where applicable
• Quality management system documents such as ISO 13485
• Free sale certificate and manufacturer authorisation for imports
• Details of the Indian manufacturer, importer or authorised agent
• Regulatory approvals from the country of origin where applicable

Benefits

• Provides lawful authority to manufacture or import the device
• Supports sales to hospitals, distributors and institutional buyers
• Builds confidence in product safety and compliance
• Enables smooth customs clearance for imported devices

Frequently asked questions