Class A (Non-Sterile & Non-Measuring) Medical Device Registration in India

Class A medical devices represent the lowest risk category under India's Medical Devices Rules, 2017 (MDR, 2017). Certain Class A devices that are both non-sterile and non-measuring (NSNM) are subject to a simplified regulatory pathway introduced through the Medical Devices (Sixth Amendment) Rules, 2022.

Under the applicable provisions, eligible Class A NSNM medical devices are exempted from the regular manufacturing and import licensing requirements, subject to registration and compliance with the conditions prescribed under the MDR, 2017.

MDR Consultants assists domestic manufacturers, importers, and foreign manufacturers through their authorised Indian representatives in understanding and completing the applicable registration requirements for eligible Class A NSNM medical devices.

What is Class A NSNM Medical Device Registration?

The Medical Devices (Sixth Amendment) Rules, 2022 introduced Chapter IIIB into the Medical Devices Rules, 2017, establishing provisions for the registration of Class A medical devices that are:

• Classified as Class A;
• Non-sterile; and
• Non-measuring.

For devices falling within this category, the applicable manufacturer or importer is required to furnish the prescribed information through the designated CDSCO online system in accordance with Chapter IIIB and other applicable regulatory requirements.

This pathway is different from the conventional manufacturing or import licence process applicable to other categories of medical devices.

Who Can Seek Registration?

The registration pathway may be relevant to:

• Indian manufacturers of eligible Class A NSNM medical devices
• Importers placing eligible Class A NSNM devices on the Indian market
• Foreign manufacturers acting through an authorised representative or applicable Indian entity
• Businesses introducing eligible low-risk medical devices in India.

The applicability of the registration framework depends on the correct classification and regulatory status of the individual device.

Step-by-Step Process for Class A NSNM Device Registration

Step 1: Assess Whether the Product Qualifies as a Medical Device

The first step is to determine whether the product falls within the definition and scope of a medical device under the applicable Indian regulatory framework.

The first step is to determine whether the product falls within the definition and scope of a medical device under the applicable Indian regulatory framework.

An incorrect regulatory determination at this stage may result in an inappropriate registration or licensing pathway.

Step 2: Confirm Device Classification and Eligibility

The device must be appropriately classified according to the provisions of the Medical Devices Rules, 2017 and relevant CDSCO classification guidance.

Medical devices are generally classified according to risk:

• Class A – Low Risk
• Class B – Low to Moderate Risk
• Class C – Moderate to High Risk
• Class D – High Risk

For registration under Chapter IIIB, the device should qualify as:

• Class A;
• Non-sterile; and
• Non-measuring.

Devices that do not meet all applicable eligibility conditions may be subject to a different regulatory approval or licensing route.

Step 3: Review Applicable CDSCO Classification Lists

Before initiating the registration process, it is advisable to verify whether the device is covered under an applicable CDSCO risk-classification list or notification.

The device name, intended use, and product characteristics should be aligned with the relevant classification information.

Where classification is unclear, a detailed regulatory assessment may be required before submission.

Step 4: Compile Product and Manufacturer Information

The applicant should organise the information required for the online registration process.

Depending on the applicable requirements and portal fields, this may include information relating to:

• Manufacturer details;
• Manufacturing facility details;
• Applicant or importer details;
• Device name and generic name;
• Intended purpose;
• Device classification;
• Product description and specifications;
• Model or variant information, where applicable;
• Labelling particulars;
• Applicable standards;
• Quality and compliance declarations; and
• Other information required through the CDSCO online system.

All submitted information should be consistent with the manufacturer's technical and quality documentation.

Step 5: Access the CDSCO Online Medical Device Registration System

The applicant must use the applicable CDSCO online platform for submission of the required registration information.

Before initiating the application, the relevant organisation and authorised user details should be properly established on the portal.

Particular attention should be given to:

• Legal entity information;
• Manufacturing site details;
• Contact information;
• Authorised signatory details; and
• Applicant credentials and declarations.

Step 6: Submit Device Registration Details

Once the necessary information has been compiled, the details of the eligible medical device are entered into the applicable CDSCO online system.

The submission should accurately reflect the device's:

• Identity and description;
• Intended use;
• Classification;
• Manufacturer;
• Manufacturing location; and
• Other prescribed regulatory particulars.

Consistency between the online submission, product labelling, technical documentation, and manufacturer records is important.

Step 7: Completion of Registration Process

Following submission of the prescribed information through the applicable online system, the registration process is completed in accordance with the provisions of Chapter IIIB of the Medical Devices Rules, 2017.

Applicants should retain relevant submission records, acknowledgements, registration details, and supporting documentation for regulatory reference.

The registration framework should not be confused with the conventional manufacturing or import licence applicable to other categories of medical devices.

Post-Registration Compliance Responsibilities

Registration does not remove the manufacturer's or importer's responsibility to comply with applicable provisions of Indian medical device regulations.

Depending on the nature of the product and applicable legal requirements, ongoing compliance may include:

Customer Benefits Include:

Manufacturers and importers should continuously monitor regulatory updates issued by CDSCO and the Ministry of Health and Family Welfare.

Documents and Information We Help You Prepare

The existing business processes and management systems are reviewed to identify the difference between current practices and ISO 9001 requirements.

• Device classification assessment;
• Intended use review;
• Product description;
• Manufacturer information;
• Manufacturing site information;
• Device specifications;
• Applicable standards assessment;
• Labelling review;
• Regulatory declarations;
• Technical documentation readiness; and
• Online submission support.

The exact documentation requirements may vary depending on the device and the information prescribed in the applicable CDSCO system.

Why Regulatory Assessment Is Important

Although the registration pathway for eligible Class A NSNM devices is simplified compared with conventional licensing routes, correct regulatory assessment remains important.

Common issues can arise from:

• Incorrect device classification;
• Incorrect interpretation of intended use;
• Inclusion of measuring functionality;
• Sterility claims or sterile presentation;
• Inconsistent product labelling;
• Mismatch between submitted and technical information; or
• Selection of an inappropriate regulatory pathway.

A structured review before submission can help manufacturers and importers identify potential regulatory gaps.

How MDR Consultants Can Assist?

MDR Consultants provides regulatory support for companies seeking to understand the Indian regulatory pathway for eligible Class A Non-Sterile and Non-Measuring medical devices.