Navigating India's medical-device regulatory framework requires careful attention to classification, intended use and applicable CDSCO requirements. For eligible Class A non-sterile and non-measuring medical devices, the Medical Devices Rules, 2017 (MDR 2017) provide a simplified regulatory pathway through registration rather than the conventional licensing route.
This framework was introduced through G.S.R. 777(E) dated 14 October 2022, which inserted Chapter IIIB – Registration of Class A (Non-Sterile and Non-Measuring) Medical Devices into the MDR 2017. Under this framework, eligible devices are exempted from specified licensing requirements, subject to obtaining the required registration number from the CDSCO Online System for Medical Devices.
This guide explains the CDSCO Class A non-sterile and non-measuring medical device registration process, eligibility requirements, documentation, compliance obligations and important considerations for Indian and foreign manufacturers.
Medical devices in India are classified according to their associated risk under the First Schedule of the Medical Devices Rules, 2017.
Class A represents the lowest risk category. However, not every Class A device automatically qualifies for the Chapter IIIB registration pathway.
The relevant device must meet the applicable requirements for being classified as a Class A non-sterile and non-measuring medical device.
The current CDSCO classification list should therefore be checked before beginning the registration process. CDSCO's current classification notice states that the list is dynamic and subject to revision from time to time. It also clarifies that variants supplied in sterile form or having a measuring function are not considered Class A non-sterile and non-measuring devices under this framework.
The principal legal framework is Chapter IIIB of the Medical Devices Rules, 2017, introduced through the Medical Devices (Sixth Amendment) Rules, 2022.
The relevant notification is:
G.S.R. 777(E), dated 14 October 2022
The notification introduced provisions specifically dealing with the registration of Class A non-sterile and non-measuring medical devices.
CDSCO continues to publish the relevant MDR 2017 notifications and medical-device regulatory materials on its official website.
For eligible Class A non-sterile and non-measuring medical devices covered by Chapter IIIB, the conventional licensing requirements do not apply in the same manner as they do to other medical devices.
The current CDSCO classification notice expressly states that devices classified as Class A non-sterile and non-measuring are exempted from licensing requirements, provided the manufacturer or importer obtains the required registration number under Chapter IIIB.
Therefore, businesses should not treat this pathway as an ordinary Form MD-5 manufacturing licence or Form MD-15 import licence application.
Instead, the applicant must complete the applicable Chapter IIIB registration process and comply with the requirements associated with the registered device.
The first step is to establish that the proposed product actually falls within the applicable Class A non-sterile and non-measuring category.
Applicants should compare the device's:
against the applicable CDSCO classification requirements and current classification list.
The intended use is particularly important. CDSCO's 31 October 2025 notice states that the general intended use listed against a device is guidance for applicants, while the manufacturer's intended use may differ provided it is in similar lines to the intended use specified in the classification list.
The device must satisfy both relevant conditions.
A device supplied in sterile form or a variant having a measuring function will not qualify as a Class A non-sterile and non-measuring device under this specific framework.
The applicant should prepare accurate information concerning the manufacturer, manufacturing site, device identity, intended use and other particulars required by the applicable registration system.
For imported devices, information concerning the overseas manufacturer and Indian authorised agent/importer should be prepared as applicable.
The applicant should also ensure that declarations and compliance statements accurately reflect the device's classification and conformity with the applicable requirements.
The registration is made through the applicable CDSCO Online System for Medical Devices.
Applicants should carefully review all information before submission because inconsistencies between the registration information, product labels, technical documents and actual device configuration can create regulatory issues.
Following successful registration, the applicable registration number is generated or issued through the regulatory system.
The registration number and other required information should be incorporated into product labelling and documentation in accordance with the applicable requirements of the MDR 2017.
The exact documentation requirements should be verified against the current CDSCO registration system and applicable regulatory provisions.
Depending on the applicant and device, relevant information may include:
The applicant should ensure that the information submitted to CDSCO is consistent with the device actually manufactured, imported, labelled and supplied in India.
A key feature of the Chapter IIIB pathway is the applicant's responsibility for ensuring that the device satisfies the applicable regulatory requirements.
Manufacturers and importers should maintain appropriate evidence demonstrating compliance with the applicable Essential Principles of Safety and Performance and other relevant MDR 2017 requirements.
Self-declaration should therefore not be treated as merely an administrative formality. The applicant remains responsible for ensuring that the device is correctly classified and complies with the applicable regulatory standards and requirements.
Obtaining a Class A registration number does not remove the requirement to comply with applicable medical-device labelling provisions.
Manufacturers and importers should review the requirements applicable to:
The final label should correspond with the information submitted during registration.
Registration under Chapter IIIB does not mean that the device is outside the regulatory oversight of CDSCO.
Manufacturers and importers should maintain appropriate records demonstrating continued compliance with the applicable requirements.
These may include records relating to:
Applicants should also monitor regulatory changes because the CDSCO classification list for Class A non-sterile and non-measuring devices is expressly described as dynamic and subject to revision.
The simplified registration pathway should not be interpreted as eliminating regulatory oversight.
Although eligible devices are exempt from the conventional licensing requirements, CDSCO and other competent authorities retain regulatory powers under the applicable legal framework.
Manufacturers and importers should therefore maintain appropriate records and be prepared to demonstrate compliance if requested by the authorities.
Businesses commonly encounter regulatory problems when they:
Class A classification alone does not establish eligibility for the Chapter IIIB exemption. The device must also meet the non-sterile and non-measuring criteria and fall within the applicable CDSCO classification framework.
Classification should be assessed together with the manufacturer's intended use. CDSCO's current classification notice specifically addresses the relationship between the intended use listed in the classification list and the manufacturer's intended use.
A sterile version of a device does not qualify as a Class A non-sterile and non-measuring device under this pathway.
A device or variant having a measuring function should not be treated as eligible under the non-measuring category.
CDSCO has stated that the Class A non-sterile and non-measuring classification list is dynamic and may be revised. Applicants should therefore verify the latest list before submission.
Registration is only one part of regulatory compliance. Product labelling, quality, safety, performance and post-market obligations should continue to be monitored.
MDR Consultants can support manufacturers and importers with:
Our approach focuses on ensuring that the device classification, intended use, registration information and supporting documentation remain consistent with the applicable CDSCO requirements.
The Class A non-sterile and non-measuring medical device registration pathway provides a simplified regulatory mechanism for eligible low-risk medical devices in India.
Introduced through G.S.R. 777(E) dated 14 October 2022, Chapter IIIB of the Medical Devices Rules, 2017 provides for registration of eligible Class A non-sterile and non-measuring medical devices and exempts them from specified licensing requirements, subject to obtaining the required registration number.
However, manufacturers and importers should not assume that every Class A device qualifies. Classification, intended use, sterility, measuring function and the current CDSCO classification list must be assessed before registration.
Because CDSCO has confirmed that the classification list is dynamic and subject to revision, applicants should verify the latest applicable CDSCO classification and regulatory requirements before submitting a registration application.
For manufacturers and importers seeking a compliant route to market for eligible low-risk medical devices, understanding Chapter IIIB, CDSCO Class A registration and the applicable MDR 2017 requirements is an important part of the Indian market-entry strategy.
Last Updated : 21 Sep 2026
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