CDSCO Notification For Class A Non-Sterile And Non Measuring Medical Device
CDSCO has issued notification to smoothen the licensing process for Class A medical devices. The Class A Medical devices are those having low to moderate risk like surgical dressings. CDSCO issued a notification on 20 September 2022, which explains that the medical devices of class A Non-sterile non measuring will require license, but the documentation requirement has been reduced. CDSCO will create new chapter as 3B in MDR 2017 for Non sterile and Non measuring devices, according to which manufacturer /importer need to self-certify the product conforming to the essential principles checklist of safety and performance of such devices.
For better understanding on the current notification go through the below video.
Key points from the notification:
- Documents need to be uploaded on the online portal: Manufacturers of Class A non-sterile and non-measuring medical devices should give the undertaking stating that the proposed device is Non sterile and Non measuring. As an importer provide details such as the name, address of importer and the name and address of manufacturing site, details of medical devices.
- Self-certify to comply with the standard prescribed in the MDR 2017.
- Provide details like Name, address of manufacturing site, details of medical devices
- As a manufacturer you need to have Self-attested copy of overseas manufacturing site or plant registration issued by competent authority.
- Importers need to maintain the record of imports along with its sale and distribution as the licensing authority may verify the records and documents at any point in time.
- Undertaking duly signed by importer/ manufacturer stating that the information furnished by applicant is true and authenticated.
- Chapter 4,5 will not be applicable to Class A Non-sterile and non-measuring medical devices.
- Manufacturers/importers should maintain the documents and records of the product that are available at site for onsite audit.
- Failure to maintain the record may suspend the license.
- This notification is strictly for Class A Non-Sterile & Non- Measuring devices.
This was long awaited news which was insisted by the industry to curtail certain regulations. Several manufacturers are waiting for the audit from the government licensing authorities. Online registration with self-declaration would make this transition process easier. As a medical device regulatory consultant, We help and guide manufacturers and importers in the registration process so that they can easily obtain the license.
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