The CDSCO, i.e., Central Drugs Standard Control Organisation, has issued a new notice listing Class-A medical devices that are non-sterile and non-measuring. These devices are now exempted from licensing under the Medical Devices Rules, 2017, but they still need registration on the CDSCO Online System. This step by the Government of India makes it easier for manufacturers and importers to sell safe, low-risk medical devices in the market. The new list helps ensure that simple healthcare products follow proper rules while reducing extra paperwork. It also supports India's goal of promoting ease of doing business and improving medical device regulation for better health safety and the growth of the medical device industry.

Licensing Exemption for Class-A Medical Devices

Under this update, Class-A (non-sterile and non-measuring) medical devices are exempted from certain chapters of the Medical Devices Rules, 2017, including Chapters IV, V, VII, VIII, and XI. However, manufacturers and importers must obtain registration numbers from the CDSCO Online System for Medical Devices as per Chapter IIIB of the rules. This exemption means manufacturers no longer need to apply for a license, but must ensure registration and compliance with quality and safety standards.

Conditions for Class-A Medical Devices

The CDSCO has outlined specific conditions for the medical devices listed as Class-A (non-sterile and non-measuring) under the Medical Devices Rules, 2017.

• The general intended use provided for each device serves as a guideline to help applicants during registration. Manufacturers may define a specific intended use, as long as it aligns with the intended purpose mentioned in the CDSCO risk classification list.
• The risk classification list is dynamic and may be revised periodically to reflect updates under the Medical Devices Rules, 2017.
• Any variant of a listed medical device that has a measuring function or is supplied in a sterile state will not be treated as a Class-A (non-sterile and non-measuring) device.

These conditions ensure accurate classification, maintain regulatory clarity, and uphold the safety and quality standards set by CDSCO.

Risk Classification List of Class-A (Non-Sterile and Non-Measuring) Medical Devices

The risk classification list includes 1069 medical devices. These are:

Importance for Manufacturers and Importers

The new CDSCO update is very important for manufacturers and importers of medical devices. It brings many benefits that make work faster and easier:

• Removes the need for long licensing steps for low-risk medical devices.
• Helps companies launch products in the market more quickly.
• Makes rules simpler and clearer for easy understanding and compliance.
• Builds confidence among small and large manufacturers in the medical device field.
• Supports India's goal of promoting innovation and local production.
• Reduces costs and time spent on regulatory processes.
• Improves trust between government authorities and medical device businesses.

By registering the devices they deal in on the CDSCO portal, companies can sell safe and approved products legally in the market.

Regulatory Impact and Future Updates

The new classification of Class-A medical devices shows a strong move to improve and simplify India's medical device regulation system. It makes India's medical device rules similar to world standards, helping to keep products safe and of good quality. This update also cuts waiting time so that simple, low-risk devices can reach hospitals and people more quickly. It further supports the government's aim to make India a major centre for making and supplying medical devices across the world.

The list of Class-A (non-sterile and non-measuring) devices is not fixed, it will be updated regularly as technology grows and new products are developed. The CDSCO Online System will remain the main platform for registration. Manufacturers and importers must check CDSCO's website often to stay fully compliant with the latest updates.

Conclusion

The new CDSCO classification of Class-A (non-sterile and non-measuring) medical devices is a big move toward making India's medical device system simple and transparent. It removes the need for long licensing steps for low-risk devices while keeping the rule of mandatory medical device registration under the Medical Devices Rules, 2017. This new update supports both manufacturers and importers by saving their time and effort, allowing faster & wider market access for safe and quality products. The dynamic nature of the list ensures it stays up to date with modern healthcare needs. With this step, CDSCO has strengthened India's position as a reliable hub for affordable and regulated medical devices, ensuring public health safety and promoting trust in the medical device market.