For CDSCO registration of Class D medical devices in India, several standards apply to ensure that devices meet safety, performance, and quality requirements. These standards include:

1. National Standards:

   • Medical Devices Rules, 2017: These rules under the Drugs and Cosmetics Act, 1940, set out the regulatory framework for the registration and regulation of medical devices in India.
   • IS (Indian Standards) Specifications: Specific Indian standards applicable to medical devices, which may include guidelines on device safety, performance, and quality.

2. International Standards:

   • ISO 13485:2016: Quality management system requirements for medical devices, ensuring that the manufacturing processes and quality control meet international standards.
   • ISO 14971:2019: Risk management for medical devices, providing guidelines for identifying and managing risks associated with medical devices.
   • ISO 10993 Series: Biological evaluation of medical devices, covering aspects such as biocompatibility and testing for cytotoxicity, sensitization, and other biological effects.
   • IEC 60601 Series: Electrical safety and performance standards for medical electrical equipment, including general requirements and specific standards for particular types of devices.

3. Clinical and Technical Standards:

   • Clinical Trials: Compliance with Good Clinical Practice (GCP) standards if clinical trials are conducted for the device.
   • Performance Standards: Relevant performance standards for the specific type of device, such as those for diagnostic devices, therapeutic devices, or monitoring equipment.

Key Points:

• Compliance: Ensure that all aspects of the device's design, manufacturing, and performance comply with both national and international standards.
• Documentation: Provide evidence of compliance with these standards in the technical documentation submitted for registration.

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