CDSCO has issued a risk-based classification list of rehabilitation and medical devices in India. As per notification the rehabilitation products need to be registered to comply with the latest medical device rule in India. For the safety, quality and performance of medical devices they are regulated under Drugs and & cosmetics 1940.
The total number of devices which are classified is 60. The below table helps manufacturers to classify their product. Here we are briefing the table. The whole list or table given on theCDSCO.GOV.inwebsite.
S.No |
Name of the device |
Intended use |
classification |
1 |
Accupressure小腿乐队 |
To wear around the calf to apply pressure |
A |
2 |
关节炎数以千万计系统, |
Used for Adjunctive therapy |
B |
3 |
Pulsed signal therapy system |
Regeneration of damaged cartilage |
C |
4 |
Parallel bar exerciser |
Use for good walking posture specially for disable person |
A |
5 |
Physical therapy steam bath |
Hot steam as therapy for patients |
B |
6 |
Arm sling |
To immobilize the arm |
A |
7 |
Gait Analysis system |
To study walking or running pattern |
A |
We have listed a few devices and the complete list of devices is given on the CDSCO website. The Class A devices are having low risk, Class B having low-moderate risk The Class C has Moderate –high risk, whereas Clas D has high risk according to classification criteria. As amedical device regulatory consultantour aim is to make you aware of updated rules and regulations, and the latest notification from CDSCO and other regulatory authorities so we have launched a monthlyNewsletter.kindly subscribe/download for more regulatory updates. We are a turnkey solution provider with a team of expert consultants who can guide you in the registration process for medical devices.
Referances-Rehabilitation updated list with public notice DC
