CDSCO Class A Medical Devices: Notification for Non-Sterile and Non-Measuring Devices
The CDSCO Class A medical devices category has received a major update to simplify the registration and licensing process. CDSCO has issued a notification to smoothen the licensing process for Class A medical devices, which are considered low to moderate risk devices such as surgical dressings.
CDSCO issued this notification on 20 September 2022, explaining that CDSCO Class A medical devices that are non-sterile and non-measuring will require a license; however, the documentation requirements have been reduced.
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Under this update, CDSCO will introduce a new Chapter 3B in MDR 2017 for non-sterile and non-measuring devices. According to this, manufacturers and importers must self-certify that the product conforms to the essential principles checklist of safety and performance for such devices.
Overview of CDSCO Notification for Class A Medical Devices
For better understanding of the current notification, go through the below video.
Key Points for CDSCO Class A Medical Devices
1. Documents Required for CDSCO Class A Medical Devices
Documents need to be uploaded on the online portal. Manufacturers of CDSCO Class A medical devices (non-sterile and non-measuring) must provide an undertaking stating that the proposed device is non-sterile and non-measuring.
As an importer, provide the following details:
- Name and address of the importer
- Name and address of the manufacturing site
- Details of the medical devices
2. Self-Certification Requirement
Manufacturers and importers of CDSCO Class A medical devices must self-certify compliance with the standards prescribed under MDR 2017.
They must provide details such as:
- Name and address of the manufacturing site
- Details of medical devices
3. Manufacturing Site Documentation
As a manufacturer, you need to have a self-attested copy of the overseas manufacturing site or plant registration issued by a competent authority.
4. Importer Record Maintenance
Importers must maintain records of imports along with sales and distribution, as the licensing authority may verify these records and documents at any time.
5. Undertaking Requirement
An undertaking must be duly signed by the importer or manufacturer stating that the information furnished is true and authenticated.
6. Regulatory Relaxation Under MDR 2017
Chapter 4 and Chapter 5 will not be applicable to CDSCO Class A medical devices that are non-sterile and non-measuring.
7. Record Maintenance and Audit Requirement
Manufacturers and importers should maintain all documents and records of the product at the site for onsite audit.
Failure to maintain records may lead to license suspension.
8. Important Note on CDSCO Class A Medical Devices
This notification is strictly applicable to CDSCO Class A medical devices that are non-sterile and non-measuring.
9. Industry Impact of CDSCO Notification
This was long-awaited news by the industry to reduce regulatory requirements for CDSCO Class A medical devices. Several manufacturers were waiting for audits from government licensing authorities.
With the introduction of online registration and self-declaration, this transition process has become easier and faster.
Looking to Register Your CDSCO Class A Medical Devices Quickly?
How Operon Strategist Helps in CDSCO Class A Medical Devices Registration
Navigating the regulatory pathway for CDSCO Class A medical devices can still be challenging. At Operon Strategist, we provide complete support for smooth and compliant registration.
We assist you with:
- CDSCO registration process (CDSCO Registration Services)
- Regulatory compliance (Medical Device Regulatory Consulting)
- QMS documentation (ISO 13485 Documentation Services)
- Plant setup (Medical Device Manufacturing Setup)
- Global approvals (FDA 510(k), CE Marking Services)
FAQs
What are CDSCO Class A medical devices?
CDSCO Class A medical devices are low-risk devices such as surgical dressings that have minimal impact on patient safety and require simplified regulatory controls.
Do CDSCO Class A medical devices require a license?
Yes, CDSCO Class A medical devices require registration or license, but the process is simplified with reduced documentation and self-certification.
What is the CDSCO notification for non-sterile and non-measuring devices?
CDSCO issued a notification on 20 September 2022 introducing simplified registration through self-certification for Class A non-sterile and non-measuring medical devices.
What is Chapter 3B in MDR 2017?
Chapter 3B is a new provision introduced for CDSCO Class A medical devices that allows self-certification instead of a full regulatory audit.
What documents are required for CDSCO Class A medical devices?
Required documents include an undertaking, manufacturing site details, device details, and self-certification of compliance with MDR 2017.
