Non-sterile and non-measuring class A medical device

There are different types of medical devices, which are broadly categorized into two groups: In Vitro Diagnostic (IVD) medical devices and medical devices other than In Vitro Diagnostic devices. These are further classified into four categories, namely Class A, Class B, Class C, and Class D. This classification is carried out in accordance with Schedule I of the Medical Devices Rules.

The classification of medical devices is primarily based on the level of risk associated with the device. Generally, devices with lower risk exposure are classified under Class A. In this article, we will discuss Class A non-sterile and non-measuring medical devices and examine whether a licence is mandatory for the import and manufacture of this category of devices.

1.What is Non-sterile and Non- Measuring Class A medical device?

Under the Medical Devices Rules, 2017, a non-sterile and non-measuring Class A medical device refers to a medical device that satisfies the following three conditions

1. It falls under Class A (low risk) as determined under the First Schedule of the Rules.
2. It is non-sterile, meaning the device is not supplied in sterile form.
3. c. It is non-measuring, meaning the device does not have a measuring function and does not provide any quantitative values of body measurements such as temperature, blood pressure, or heart rate.
   

   Rule 19G (1) specifically provides that the provisions of this chapter (Chapter IIIB) apply to all non-sterile and non-measuring devices classified as Class A medical devices as per the First Schedule

2. Is a licence mandatory for the import of non-sterile and non-measuring Class A medical devices?

There is no mandatory requirement for obtaining a licence for the import or manufacture of non-sterile and non-measuring Class A medical devices. However, importers and manufacturers are required to obtain registration for such devices by registering on the CDSCO portal. Upon successful registration, a registration number is granted, which is valid for both import and manufacturing activities.

3.What are the documents required for registration of Non-sterile and non-measuring class A medical Device?

For the registration of non-sterile and non-measuring Class A medical devices, the following documents are required. The list provided is indicative in nature

1. Name and address of manufacturing site
2. Details of medical device including
   1. Generic Name
   2. Brand Name ( if registered under the trade Marks Act, 1999)
   3. Model No. if any
   4. Intended use
   5. Material of construction
   6. Free sale certificate (In case of Import )