Medical Device Act B.E. 2551 was recently updated in October 2009 with new supplemental laws. These include Premises of Medical Device Manufacturing, Premise of Medical Device Importation, and The Rate of Medical Device Fees. Medical device manufacturers must describe their facility and equipment used for manufacturing, including details on quality control measures and storage facilities. Medical device importers must also do the same. The last supplemental law establishes fees for various medical device licenses and certificates.
Other Ministerial announcements were implemented in November 2009. These include medical device registration requirements for contact lenses and HIV test kits, and medical device manufacturers and importers requiring proper registration and licensing.
In addition to these supplemental laws and announcements, Thailand’s Ministry of Public Health is drafting additional laws. These include regulations on dental equipment, physical therapy equipment, in-vitro diagnostic kits, labels and inserts, and advertising.