The Centre has instructed all producers and importers of Class A medical devices to show the product’s generic name, brand name, intended use, construction material, and shelf life due to concerns over quality and safety. Catheters, disposable perfusion sets, and surgical dressings are some examples of these low-risk, non-sterile equipment. According to the government, this data must also be transmitted via its “Online System of Medical Devices.”
Formerly, manufacturers were not required to provide the government with the precise information. The Center has suggested Class A category medical device registration in the new notification, making these pharmaceutical goods registerable through a specific web portal created for this purpose.
“Medical device manufacturers must upload the information.” such as the name and address of the manufacturing facility, information about the medical device, such as its model number, intended application, size, shelf life, and construction material. Additionally, the producers and importer must self-certify that the product meets the requirements set forth in the 2017 Medical Device Rules and the Essential Principles Checklist for the Safety and Performance of Such Devices “the notification stated.
“In addition, this manufacturer or importer must keep track of all sales and distribution as well as manufacturing and import transactions, and if needed, must produce these documents to the licencing authority. The licencing authorities can check the records and documentation at any time, as well as look into any complaints or failures relating to quality or safety “mentioned in the document.
Indian medical equipmentare divided into four groups: class A, which represents low-risk medical devices, class B, low-to-moderate risk, class C, moderate-to-high risk, and class D, which represents high-risk medical devices.
Class D equipment manufacturers must adhere to a rigid process in order to get production licences.