All the manufacturers of medical devices are required to obtain a medical equipment registration and a manufacturing license as per the Drugs and Cosmetics Act. Manufacture means a process or apart of the process for creating, changing, ornamenting, accomplishing,packing, labelling and breaking up or simply adopting a drug in view of its sale as per the clause of section 3 of Drugs and Cosmetics Act.
Ithas been recently notified by the Directorate General of Health Services,Ministry of Health and Family Welfare and was recently brought to the notice of Central Drugs Standard Control Organization or CDSCO that the medical device manufacturers are facing some issues for establishing facilities for carrying out certain activities like coating and sterilization.
The manufacturers are struggling for setting up facilities to carry our function slike assembling and coating and sterilization of devices for which CDSCO grant licenses to all those sites for carrying out such activities. Upon asking the state regulators to issue licenses to all those companies that wish to perform the tasks, the realities behind the difficulties for getting the regulatory clearances clearly come out.
This imprint is covered by a part of the circular that states out why any regulatory resistance to the granting of licenses runs counter to the Drugs and Cosmetics Act. The legislation states that manufacture means any task that includes the production, changing, packing and labelling or otherwise treating any drug or devices. Thus, as per DGCI, coating, assembly as well as sterilization of the medical devices are covered by the definition of manufacture.
Companies thus need a license to perform these tasks and also by further extension, allstate agencies should give license to all organizations for meeting the requirements for conducting these applications.
The decision taken by CDSCO is quite obvious, since these activities are directly associated with the medical device in some way or the other.
