Class A Non-Sterile, Non-Measuring Medical Devices: Regulatory Requirements in India

The medical device regulatory framework in India is governed by the Medical Devices Rules (MDR), 2017, administered by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

Medical devices are classified into four categories according to their risk level: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).

Within this framework, Class A non-sterile, non-measuring medical devices benefit from a simplified regulatory pathway. Under the amendment introduced through G.S.R. 777(E), dated 14 October 2022, these devices are exempt from specified licensing requirements. However, exemption from licensing does not mean exemption from all regulatory obligations. Mandatory registration, applicable labelling requirements, and other relevant compliance requirements remain important.

1. What Are Class A Non-Sterile, Non-Measuring Medical Devices?

Class A non-sterile, non-measuring medical devices are medical devices categorized as low risk that are neither intended to be supplied in a sterile state nor designed to perform a measuring function.

To qualify for this category, a device must satisfy the applicable CDSCO classification criteria and fall within the relevant notified classification list.

The following characteristics help distinguish this category:

• Class A: The device falls within the applicable low-risk classification.
• Non-sterile: The manufacturer does not intend to supply the device in a sterile state.
• Non-measuring: The device does not perform a regulated quantitative measurement function as defined under the applicable rules.

It is important to verify the classification of the specific device rather than relying solely on its commercial name or general description.

2. Regulatory Framework Applicable to Class A Devices

The primary regulatory provisions include:

• Medical Devices Rules, 2017.
• G.S.R. 777(E), dated 14 October 2022, concerning exemption from specified licensing requirements.
• The applicable CDSCO risk-based classification list for Class A non-sterile, non-measuring medical devices.
• Relevant labelling requirements under the Medical Devices Rules, 2017.
• Applicable standards and essential principles of safety and performance.

CDSCO published an updated risk-based classification list for this category on 31 October 2025. Manufacturers and importers should consult the current list to confirm whether their particular device qualifies.

3. Is a Manufacturing or Import Licence Required?

One of the most significant features of this regulatory category is the exemption from specified licensing requirements.

Under the applicable provisions, qualifying Class A non-sterile, non-measuring medical devices are exempt from the relevant licensing requirements under specified chapters of the Medical Devices Rules, 2017.

However, the exemption does not eliminate the need for mandatory registration.

Mandatory registration

Manufacturers and importers must furnish the prescribed information through the CDSCO Online System for Medical Devices and obtain a system-generated registration number.

According to CDSCO guidance:

• A separate manufacturing or import licence is not required under the specified exemption.
• Registration through the prescribed online system remains mandatory.
• No registration fee is specified for obtaining this registration number under the applicable provisions.

Companies should verify the current online registration procedure and any applicable amendments before placing a device on the Indian market.

4. Registration Requirements for Manufacturers

Manufacturers intending to market qualifying Class A non-sterile, non-measuring medical devices in India should prepare the prescribed registration information.

The information generally includes:

1. Name and address of the manufacturing site.
2. Generic name of the medical device.
3. Brand name, where applicable.
4. Model number, if applicable.
5. Intended use of the device.
6. Material of construction.
7. Dimensions, where applicable.
8. Shelf life, where applicable.
9. An undertaking confirming that the device qualifies as a Class A non-sterile, non-measuring medical device.
10. Self-certification concerning conformity with the essential principles of safety and performance.
11. Self-certification concerning compliance with applicable standards.
12. An undertaking confirming the accuracy and authenticity of the information submitted.

The exact information and declarations should be checked against the current requirements under the Medical Devices Rules, including the provisions governing this category.

5. Registration Requirements for Importers

Importers must also complete the prescribed registration process for qualifying Class A non-sterile, non-measuring devices.

The importer should verify the device classification, identify the manufacturer and manufacturing site, and ensure that the required product information and declarations are available.

Key compliance activities include:

• Confirming that the imported device is included in the applicable classification list.
• Collecting accurate device and manufacturer information.
• Submitting the prescribed information through the CDSCO online system.
• Obtaining the system-generated registration number.
• Ensuring that the imported product complies with applicable labelling and standards requirements.

The exemption should not be interpreted as a blanket exemption for all imported medical devices. Devices supplied sterile or having a measuring function may fall outside this category.

6. Quality Management System Requirements

A common misconception is that exemption from licensing automatically removes quality management obligations.

This is not correct.

CDSCO guidance clarifies that the manufacturing facility for Class A non-sterile, non-measuring medical devices must conform to the applicable quality management system requirements for medical devices.

Manufacturers should establish and maintain suitable documented procedures covering areas such as:

• Control of manufacturing processes.
• Incoming material inspection and acceptance.
• Product inspection and verification.
• Identification and traceability, where applicable.
• Handling of non-conforming products.
• Complaint management.
• Corrective and preventive actions, as appropriate.
• Control of relevant records.
• Management of product changes.

The scope and implementation of the quality management system should be determined with reference to the applicable regulatory provisions and the device's characteristics.

7. Labelling Requirements

Labelling is a key compliance requirement even when a device is exempt from specified licensing provisions.

The product label should comply with the applicable provisions of the Medical Devices Rules, 2017, and any relevant amendments or standards.

Depending on the applicable requirements, labelling information may include:

• Name of the medical device.
• Name and address of the manufacturer.
• Manufacturing site details, where required.
• Batch or lot number, where applicable.
• Manufacturing date and expiry date or shelf-life information, where applicable.
• Intended use and necessary instructions.
• Storage conditions, where applicable.
• Other prescribed declarations and identification information.

Manufacturers and importers should verify the precise labelling requirements applicable to their device instead of treating this list as a complete or universally applicable label template.

Labelling must also remain consistent with the registered product information and the manufacturer's intended use.

8. Essential Principles of Safety and Performance

Manufacturers should ensure that the device conforms to the applicable essential principles of safety and performance.

This involves identifying relevant safety and performance requirements and maintaining appropriate evidence that the device meets them.

Depending on the device, supporting documentation may include:

• Product specifications.
• Design and development records, where applicable.
• Material specifications.
• Risk assessment documentation.
• Verification and validation records, as applicable.
• Test reports.
• Instructions for use and product labelling.
• Evidence of conformity with applicable standards.

Self-certification does not remove the manufacturer's responsibility to ensure that the device is safe and performs as intended.

9. How to Confirm Whether a Device Qualifies

Before applying the simplified registration pathway, manufacturers and importers should carry out a classification assessment.

A practical assessment should cover the following questions:

Step 1: Confirm the intended medical purpose.
Establish whether the product meets the applicable definition of a medical device under Indian law.

Step 2: Verify the risk classification.
Check the applicable CDSCO classification list and relevant classification rules.

Step 3: Confirm that the device is non-sterile.
A device intended to be supplied in a sterile state does not qualify for this category.

Step 4: Confirm that the device is non-measuring.
Assess whether the device is intended to measure a quantitative physiological or anatomical parameter, or another quantity covered by the applicable definition.

Step 5: Complete registration and compliance activities.
Submit the required information, obtain the registration number, and meet the applicable quality, labelling, safety and performance requirements.

If the device does not satisfy all relevant conditions, the manufacturer or importer should determine the appropriate regulatory pathway before marketing it.

10. Common Compliance Mistakes to Avoid

Companies should be careful to avoid the following errors:

• Assuming that all Class A devices are exempt from licensing.
• Treating registration as optional because a separate licence is not required.
• Relying on an outdated classification list.
• Incorrectly classifying a sterile or measuring device as non-sterile, non-measuring.
• Ignoring quality management system requirements.
• Using product labels that do not meet the applicable regulatory provisions.
• Submitting incomplete or inconsistent manufacturer and product information.
• Assuming that registration alone establishes conformity with every applicable requirement.

A documented regulatory assessment can help companies avoid these errors and support a smoother registration process.

Conclusion

The regulatory pathway for Class A non-sterile, non-measuring medical devices in India is designed to reduce specified licensing burdens while retaining important safeguards for product safety and performance.

Manufacturers and importers should focus on four essential activities: confirming the correct classification, completing mandatory registration, maintaining the applicable quality management system, and complying with labelling and other relevant requirements.

The latest CDSCO classification list and applicable amendments should always be reviewed before a device is registered or marketed. A device that falls outside the exemption must follow its applicable regulatory pathway under the Medical Devices Rules, 2017.

Last Updated : 14 Oct 2026