Ensure that your device qualifies as a Class A medical device, which is considered low-risk. Class A devices typically have minimal impact on the body and are non-invasive.

Confirm that your device is classified as Class A. This classification pertains to low-risk medical devices with minimal impact on the body.

Class A medical devices are considered low-risk devices. These devices are typically non-invasive and have minimal impact on the body. Examples might include bandages, non-prescription eyeglasses, and certain types of dental floss. The classification is based on the device’s intended purpose and potential risks.

Obtaining CDSCO registration for Class D medical devices typically takes between 6 to 12 months. The duration can vary based on several factors, including the completeness of the application, the complexity of the device, and the efficiency of the review process.

Duration: The registration certificate is valid for 5 years from the date of issuance.

Legal Requirement: CDSCO registration is a legal requirement under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. It authorizes the manufacturer to legally market and distribute Class D medical devices in India.

Activities: Preparing all required documentation, including clinical data, technical details, and quality management system information.

Purpose: The registration ensures that the device meets the safety, effectiveness, and quality standards set by CDSCO.