Regulations Governing Registration of Medical Devices.

The purpose of these Regulations is to enforce the legal framework to ensure effective and efficient registration of medical devices, and to provide an open, transparent and non-discriminatory process for the registration of medical devices.
The text classifies the medical devices and describes the application procedure and the requirements for their registration. The texts includes provisions concerning the publication of a registered device, the validity of a registration, its variation, renewal, suspension and cancellation, as well as the refusal to issue a registration certificate.
The Regulations also provide for restrictions for sale of unregistered medical devices.