The Ministry of Public Health in Thailand announced in late 2002 that it is drafting a new Medical Device Act. The new act will include revised registration requirements as well as regulations on product liability. The act will also outline the licensing requirements of manufacturers and distributors and their required fees. The new Medical Device Act is expected to be implemented by 2007. Currently, deliberations are taking place between the Thai Food and Drug Administration (FDA) and the medical device industry in Thailand before the new act is finally submitted to the parliament for approval. Once the new act is in force, all previous registrations will remain current and valid until their individual expiration dates.
The first Medical Device Act in Thailand was instituted in 1988. The act required that all medical devices, including condoms and surgical gloves, be registered with the government. Medical devices were divided into three classes (Class I, II, and III). The new Medical Device Act will be generally based upon the European Union’s Medical Device Directive.