Manufacturing Registration for Class A Medical Devices as per GSR 777(E)
G.S.R. 777(E) Registration Support for Eligible Class A Medical DevicesManufacturers and importers of eligible low-risk medical devices in India must understand the applicable regulatory pathway before placing their products on the market.
Under the Medical Devices Rules, 2017, as amended through G.S.R. 777(E) dated 14 October 2022, a separate registration framework was introduced for eligible Class A non-sterile and non-measuring medical devices.
These eligible devices are exempt from the applicable licensing requirements, subject to registration under Chapter IIIB of the Medical Devices Rules, 2017 and fulfilment of the prescribed conditions.
MDR Consultants provides regulatory support to manufacturers and importers for understanding device eligibility, classification, documentation and registration of eligible Class A non-sterile and non-measuring medical devices through the CDSCO Online System.
Understanding Class A Non-Sterile and Non-Measuring Medical Devices
Medical devices are classified based on their associated risk and applicable classification rules.
The registration pathway introduced under G.S.R. 777(E) applies specifically to medical devices that meet all of the following conditions:
- Classified as Class A;
- Supplied in a non-sterile state
- Do not have a measuring function
These conditions are important. A device that is classified as Class A but is supplied sterile or has a measuring function may not fall within the same registration pathway.
The classification of a medical device should be assessed based on its intended purpose, design and the applicable classification provisions under the Medical Devices Rules, 2017.
What Does G.S.R. 777(E) Mean for Eligible Class A Devices?
G.S.R. 777(E) introduced Chapter IIIB – Registration of Class A (Non-Sterile and Non-Measuring) Medical Devices into the Medical Devices Rules, 2017.
The framework provides for registration of eligible Class A non-sterile and non-measuring medical devices through the CDSCO Online System.
In practical terms:
This pathway should not be confused with the manufacturing or import licensing pathways applicable to other categories of medical devices.
Who Needs to Register?
The registration provisions may apply to eligible Class A non-sterile and non-measuring medical devices placed on the Indian market.
Indian Manufacturers
Indian manufacturers of eligible Class A non-sterile and non-measuring medical devices are required to register the applicable manufacturing site and medical devices through the prescribed CDSCO Online System.
Importers / Authorised Indian Entities
For eligible imported Class A non-sterile and non-measuring medical devices, the applicable registration process involves registration of the foreign manufacturing site and relevant medical device details through the CDSCO Online System.
The exact applicant arrangement and documentation should be assessed based on the specific import and manufacturer structure.
Common Information Required for Registration
The registration process requires accurate information regarding the applicant, manufacturing site and medical device.
Depending on whether the device is manufactured in India or imported, the information and supporting documents may include:
• Registered business details
• Address
• Contact information
• Constitution or legal status of the organisation, where applicable
• Manufacturing site information
• Site address
• Manufacturing activity details
For imported devices:
• Foreign manufacturing site details
• Manufacturer name and address
• Country of origin
• Medical device name
• Brand name, where applicable
• Intended purpose
• Generic description
• Model or variant details, where applicable
• Device classification
• Non-sterile status
• Non-measuring status
Applicants should ensure that the available quality documentation is current and relevant to the manufacturing activity.
• Accuracy of submitted information
• Device classification
• Applicable regulatory compliance
• Safety and performance requirements
• Compliance with relevant provisions of the Medical Devices Rules, 2017
The precise documentation and information requirements should be checked against the current CDSCO Online System requirements at the time of submission.
Registration Process for Class A NSNM Medical Devices
Identify the Medical Device
The first step is to clearly identify the medical device proposed for registration.
Important information includes:
• Device name
• Intended purpose
• Product description
• Manufacturer details
• Manufacturing site
• Models or variants, where applicable
Clear product identification is essential for an accurate regulatory assessment.
Confirm Regulatory Classification
The device should be assessed to determine whether it qualifies as:
Class A + Non-Sterile + Non-Measuring
The assessment should consider:
• Intended use
• Design characteristics
• Sterility status
• Measuring function
• Applicable classification rules
• Relevant CDSCO classification lists
This step is important because incorrect classification can result in selecting an
inappropriate regulatory pathway.
Assess Eligibility Under Chapter IIIB
Once the classification is established, the applicability of the Class A NSNM
registration pathway should be assessed.
The device should meet the applicable conditions for registration under Chapter IIIB
of the Medical Devices Rules, 2017.
A device that does not meet the eligibility criteria may require a different
regulatory pathway.
Prepare Registration Information and Documentation
The applicant should compile the relevant information relating to:
• Applicant
• Manufacturer
• Manufacturing site
• Medical device
• Intended purpose
• Classification
• Models or variants
• Applicable quality documentation
• Required declarations
All information should be reviewed for consistency before submission.
Register Through the CDSCO Online System
The precise documentation and information requirements should be checked against the
current CDSCO Online System requirements at the time of submission.
The registration is completed through the applicable CDSCO Online System for Medical
Devices.
The applicant enters the required establishment and device information and uploads
applicable supporting documentation.
Before final submission, it is important to verify:
• Manufacturer details
• Manufacturing site information
• Device name
• Intended purpose
• Classification
• Device variants
• Supporting documentation
Accurate data entry is important because the registration information forms part of the
regulatory record.
Obtain Registration Number
Upon successful completion of the applicable registration process, a registration number
is generated through the CDSCO Online System.
The registration number is relevant to the regulatory identification of the eligible
Class A non-sterile and non-measuring medical device.
The applicant should maintain appropriate records relating to the registration and
device information.
Key Benefits of Proper Registration Planning
Key Benefits of Proper Registration Planning
How MDR Consultants Can Assist?
MDR Consultants provides regulatory consulting and documentation support for eligible Class A non-sterile and non-measuring medical devices.
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Classification and Eligibility Assessment:
We assess the device and intended purpose to help determine whether the Class A NSNM registration pathway may be applicable. -
Regulatory Pathway Assessment:
Our team helps manufacturers and importers understand the applicable regulatory framework under G.S.R. 777(E) and Chapter IIIB of the Medical Devices Rules, 2017. -
Device Information Review:
We assist with organising and reviewing:
• Device descriptions
• Intended purpose
• Classification information
• Model and variant details
• Manufacturer information -
Documentation Support:
MDR Consultants helps identify and organise the applicable documentation and regulatory information required for registration. -
CDSCO Online Registration Support:
We assist clients with the applicable registration workflow through the CDSCO Online System for Medical Devices. -
Compliance and Consistency Review:
Before submission, we help review information for consistency between:
• Manufacturer details
• Manufacturing site information
• Device details
• Classification
• Intended purpose
• Supporting documentation -
Regulatory Support:
Our team provides guidance on the applicable regulatory requirements and documentation considerations associated with the registration pathway.
MDR Consultants – Regulatory Support for Class A NSNM Medical Device Registration in India
From initial device assessment and classification review to documentation organisation and CDSCO Online System registration support, our team provides structured regulatory assistance throughout the process.
