- According to the Rules, all class ‘A’ medical device manufacturers have to register themselves through an online portal established for the purpose.
- According to the 1st Schedule of the Rules, the manufacturer will be required to give an undertaking stating that the proposed device is a class A medical device (non-sterile and/or non-measuring).
- The Rules further stated that the importer of medical devices will have to give an undertaking too, stating that the proposed device is a class A medical device.
- The records of manufacturing, import, along with sales, and distribution will have to be maintained by both, the manufacturer and the importer.
- Class ‘A’ medical devices (Nasopharyngeal Catheter, Umbilical Occlusion Device, Alcohol Swabs, etc.) are those with low-to-moderate risk to the patients.
Question:
Q.1 According to the Medical Devices (Amendment) Rules, 2022, the manufacturer and the importer will be required to give an undertaking for?a. Class A Medicinal Device
b. Class B Medicinal Device
c. Class C Medicinal Device
d. Class D Medicinal Device
