The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020.
“To improve the nation’s Drugs and Cosmetics Act for making applicable Indian Regulation act, the Health Ministry of India has distributed new medical devices and IVD guidelines.
Under the Indian Regulation Act, Central Drugs Standard Control Organization, CDSCO classifications of medical devices headed by Drug Controller General of India (DCGI) classifies medical devices into four classes (A, B, C, and D) as per the regulation.
The medical devices according to the Indian Regulation Act are segregated into classes via risk-based classification. The risk of the medical device is determined on the basis of its intended use and purpose. This new risk-based approach sets the different levels for regulating the devices corresponding to their classes relying upon the risks and technology related to the device intended use and technological characteristics.
- Low Risk – Class A – (Absorbent cotton wools, surgical dressing, alcohol swabs etc).
- Low Moderate Risk – Class B – (Thermometer, BP monitoring device, disinfectants etc).
- Moderate High-Risk – Class C – (Implants, hemodialysis catheter etc).
- High risk – Class D – (Angiographic guide wire, heart valve).
The CDSCO notice pertains to the following device types, all of which will be assigned moderate to moderate-high Class B and Class C risk classifications:
- CT scan equipment (Class C).
- MRI equipment (Class C).
- Defibrillators (Class C).
- Dialysis machines (Class C).
- PET equipment (Class C).
- X-ray machines (Class C).
- Bone marrow cell separators (Class B).
- Nebulizers (Class C).
- Blood pressure monitoring devices (Class B).
- Digital thermometers (Class B).
- Glucometers (Class C IVD).
- Organ preservation solutions (Class C).
According to the Indian Regulation Act it is essential to have CDSCO license to manufacture, distribute, import or sell a medical device product.
These risk classifications as per the Indian Regulation act will allow Indian medical device market registrants and their in-country representatives to get a better idea of issues such as cost, clinical data requirements (if any) and import licensing authority as they commercialize their products in India.
If you need any assistance in registering your product in Indian Market, please contact us.
