In February 2005, the Malaysian Government decided to begin regulating medical devices. This new regulatory system for medical devices will be in accordance with the regulatory requirements of the Global Harmonization Task Force, World Health Organization, and World Trade Organization. The first step in the development and implementation of medical device regulations was the initiation of the Voluntary Registration of Medical Devices Establishments (MeDVER), recently launched on January 12, 2006 by the Malaysian Minister of Health.
MeDVER is a voluntary registration system for Malaysia’s medical device establishments. Medical device establishments include manufacturers, exporters/importers, and distributors/vendors of medical devices. Its purpose is to familiarize medical device companies with: (1) the registration process, (2) to measure the capacity of device companies to conform to the regulatory requirements, (3) to prepare medical device companies for an easy transition into the mandatory regulatory phase, and (4) to further acquire a profile of the Malaysian medical device industry.
Although this registration system is voluntary, all Malaysian establishments related to medical devices are encouraged to participate. The registration system is web-based and consists of two main steps that may be completed on-line. First, the medical device establishment must create an account. Second, the establishment must enter the required information, which includes the establishment information, person responsible, medical device information, post-market requirements, and application declaration. All applications must be made by using the forms on the MeDVER website at http://www.medicaldevices.gov.my.
The implementation of MeDVER is a proactive step by the Malaysian Government in the first phase of establishing Malaysia’s medical device regulations. The government hopes this will be the beginning to a more comprehensive regulatory system in the future.