Get to know about the Class A Non-Sterile Non-Measuring Medical Devices registration in India for the benefit regulatory.
These are non-invasive low-risk devices. These devices do not monitor or measure any physiological parameters.
Class A medical devices are categorized as having the lowest risk and are typically non-sterile and non-measuring devices. They are generally simple in design and either has no direct contact with the human body or only minimal contact. Here are a few examples of Class A non-sterile non-measuring devices. Adhesive bandages, Cotton swabs, Tongue depressors, Non-medicated disposable gloves, Elastic bandages.
Who Needs This Licence
Manufacturers or importers of class A NSNM medical devices are typically required to register their devices with the regulatory authorities before they can be legally marketed and sold.
List Of Documents Required For Class A Non-Sterile Non-Measuring Medical Devices
An undertaking from the manufacturer stating that the proposed device is a Class A Non-Sterile Non-Measuring Medical Devices, as per the First Schedule of said rules.
The manufacturer shall self-certify that the product is conforming to the essential principles checklist of safety and performance of such devices.
The manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017.
Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is authentic.
Govt. Fee Involved
The government does not charge makers or importers any registration fees for Class A (Non-Sterile and Non-Measuring) medical device registration.
After the submission of the required information, you will be able to get the registration number for your Class A non-sterile non-measuring equipment via CDSCO Registration Online System, allowing you to market and distribute the device in India.
How We Can Assist You?
- Regulatory guidance
- Gap analysis
- Drafting of documents
- Evaluation of data
- Application submission
- Responding to query