Registration of Class A (Non-Sterile and Non-Measuring) Medical Devices under G.S.R. 777(E): Simplified Online Registration Framework

The Government of India has introduced a simplified regulatory framework for low-risk Class A medical devices that are non-sterile and non-measuring through the Medical Devices (Sixth Amendment) Rules, 2022 notified vide G.S.R. 777(E).

This amendment inserts a dedicated Chapter IIIB into the Medical Devices Rules, 2017 and provides a simplified online registration mechanism for eligible Class A medical devices. The objective is to reduce the regulatory burden on manufacturers and importers while ensuring continued compliance with essential safety and performance requirements.

The provisions came into force upon publication in the Official Gazette.

Applicability of the New Registration Framework

The provisions under Chapter IIIB apply specifically to:

Class A Non-Sterile and Non-Measuring Medical Devices classified under the First Schedule of the Medical Devices Rules, 2017.

These are generally low-risk medical devices that do not possess sterile characteristics and do not perform measuring functions.

Examples may include:

• Non-sterile examination gloves
• Non-sterile surgical masks
• Basic dressings and bandages
• Certain non-invasive disposable medical consumables

Sterile Class A devices and Class A devices having measuring functions are not covered under this exemption framework and continue to require licensing under the conventional regulatory pathway.

Introduction of Chapter IIIB under G.S.R. 777(E)

Through G.S.R. 777(E), the Central Government inserted Chapter IIIB comprising Rules 19G to 19M into the Medical Devices Rules, 2017.

The newly inserted provisions establish:

• Online registration requirements
• Self-certification obligations
• Record maintenance responsibilities
• Conditions for suspension or cancellation of registration

The registration process is administered through the Online System for Medical Devices established by the Central Drugs Standard Control Organization (CDSCO).

Online Registration Process for Manufacturers

Manufacturers of eligible Class A Non-Sterile and Non-Measuring medical devices are required to upload prescribed information on the Online System for Medical Devices.

The following information is required:

Manufacturing Site Details

• Name and complete address of the manufacturing site

Device Information

• Generic Name
• Brand Name (if registered under the Trade Marks Act, 1999)
• Model Number (if applicable)
• Intended Use
• Material of Construction
• Dimensions (if applicable)
• Shelf Life (if applicable)

Mandatory Undertakings and Self-Certifications

The manufacturer must also submit:

• An undertaking confirming that the device qualifies as a Class A Non-Sterile and Non-Measuring medical device
• Self-certification confirming conformity with Essential Principles of Safety and Performance
• Self-certification regarding compliance with applicable standards under the Medical Devices Rules, 2017
• A signed declaration confirming authenticity and correctness of submitted information

Upon successful submission of the required details, the Online System generates a Registration Number.

Online Registration Process for Importers

Importers intending to import eligible Class A Non-Sterile and Non-Measuring medical devices are also required to register through the Online System for Medical Devices.

The importer must upload:

Importer and Manufacturing Site Details

• Name and address of the importer
• Name and address of the overseas manufacturing site

Device Information

• Generic Name
• Brand Name
• Model Number (if applicable)
• Intended Use
• Material of Construction
• Dimensions (if applicable)
• Shelf Life (if applicable)

Mandatory Compliance Documents

The importer must additionally provide:

• Self-undertaking confirming device classification
• Self-certification regarding safety, performance, and applicable standards
• Self-attested copy of:
  • Overseas manufacturing site registration; or
  • Free Sale Certificate issued by the National Regulatory Authority in the country of origin
• Declaration regarding authenticity of information

After successful submission, the Online System generates a Registration Number for import.

Government Fee Position under Chapter IIIB

Currently, no government registration fee has been specifically prescribed for online registration of eligible Class A Non-Sterile and Non-Measuring medical devices under Chapter IIIB introduced through G.S.R. 777(E).

However, manufacturers and importers should regularly monitor official CDSCO notifications and guidance documents for any future amendments or fee-related updates.

Key Compliance Obligations

Although the registration pathway has been simplified, manufacturers and importers remain responsible for ongoing regulatory compliance.

Under Rule 19L, registrants must:

• Maintain records relating to manufacturing/import activities
• Maintain sales and distribution records
• Preserve labels, Instructions for Use (IFU), and associated documentation
• Produce records and documents upon request by Licensing Authorities

The Licensing Authorities may verify records or investigate safety and quality-related complaints at any time.

Suspension or Cancellation of Registration

Under Rule 19M, the State Licensing Authority or Central Licensing Authority may suspend or cancel a registration if the registrant fails to comply with the provisions of Chapter IIIB.

Before passing such an order, the authority is required to provide the registrant with an opportunity to be heard.

An aggrieved party may file an appeal before the State Government or Central Government within 45 days from receipt of the order.

Exemptions Provided under the Eighth Schedule

G.S.R. 777(E) also introduced new entries in the Eighth Schedule to the Medical Devices Rules, 2017.

Accordingly:

Manufacturing Exemption

Manufacturing of eligible Class A Non-Sterile and Non-Measuring medical devices is exempt from several provisions of:

• Chapter IV
• Chapter VII
• Chapter VIII
• Chapter XI

subject to mandatory online registration under Chapter IIIB.

Import Exemption

Import of eligible devices is similarly exempt from several provisions of:

• Chapter V
• Chapter VII
• Chapter VIII
• Chapter XI

subject to online registration requirements.

These exemptions significantly reduce regulatory complexity and compliance timelines for low-risk medical devices.

Importance of the Amendment

The introduction of Chapter IIIB reflects the Government’s initiative to improve ease of doing business in the Indian medical device sector, particularly for MSMEs and manufacturers dealing with low-risk devices.

The framework adopts a balanced approach by:

• Simplifying registration requirements
• Introducing self-certification mechanisms
• Retaining post-market oversight and regulatory accountability

This helps facilitate faster market access while maintaining essential patient safety safeguards.

Conclusion

Manufacturers and importers dealing with eligible Class A Non-Sterile and Non-Measuring medical devices should ensure timely registration through the CDSCO Online System for Medical Devices.

The framework introduced under G.S.R. 777(E) provides a simplified, paperless, and streamlined registration mechanism while continuing to impose important compliance obligations relating to safety, documentation, and regulatory accountability.

Last Updated : 23 May 2026