CDSCO Updates List of Class A Non-Sterile and Non-Measuring Medical Devices

CDSCO Updates List of Class A Non-Sterile and Non-Measuring Medical Devices

The Central Drugs Standard Control Organisation (CDSCO) has recently issued an updated list of Class A non-sterile and non-measuring medical devices, expanding the total number to 1,069 devices. This update has been made to strengthen risk-based classification and streamline the medical device registration process under the Medical Devices Rules (MDR) 2017.

This classification announced by the Drugs Controller General of India (DCGI), ensures greater regulatory clarity for both domestic manufacturers and medical device importers in India.

Regulatory Update: Expansion of Class A Devices

According to the notification, this list expands the previous set of 803 devices to include several additional categories. These Class A medical devices fall under the low-risk category, defined under Rule 4 of Chapter II of the MDR 2017, and are exempted from licensing requirements, provided that manufacturers or importers obtain a registration number through the CDSCO Online System for Medical Devices under Chapter IIIB of the Rules.

The Central Licensing Authority (CLA) has the power to classify, modify, or delete entries in the list, ensuring the regulatory framework remains dynamic and updated as per technological advancements and stakeholder feedback.

Scope of the Updated List

The newly included medical devices cover a wide range of non-sterile, non-measuring instruments such as:

• Reusable abdominal scissors, ENT and orthopedic probes
   
• Adhesive pads, pressure relief cushions, and alcohol swabs
   
• Alternating-pressure mattresses and ambulance stretchers
   
• Anatomical models for surgical planning, ankle caps, and birthing tables
   

These devices are classified as low-risk medical devices and are therefore not subject to the same stringent licensing procedures applicable to higher-risk categories such as Class B, C, and D devices.

Registration and Compliance Requirements

Manufacturers and importers of Class A non-sterile and non-measuring devices are now required to obtain registration under Chapter IIIB through the CDSCO online portal.
They must also provide details of the intended use, manufacturer’s information, and device specifications as per the First Schedule of MDR 2017.

While licensing exemption applies to these products, registration remains mandatory to ensure traceability, regulatory compliance, and market accountability.

Implications for the Industry

This updated classification offers regulatory ease to manufacturers dealing with low-risk devices, simplifying their registration process and reducing administrative burden.
It also benefits healthcare professionals, suppliers, and consumers by ensuring that even low-risk devices meet minimum safety and quality standards under the Indian medical device regulatory framework.

The CDSCO circulars and notifications play a vital role in keeping the medical device ecosystem informed about evolving compliance expectations, further strengthening India’s regulatory governance in the healthcare sector.

Click here to know more and access the official guidance document

Note:
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