ABSTRACT
Thailand’s endeavor to become the medical hub of Asia. Thailand’s medical device market in 2010 and 2011 was worth US$ 795 million and US$ 900 million, respectively, and it is expected to reach US$ 15 billion in 2015. The majority of the supply of medical devices in Thailand still depends on imports. As of July 5, 2012, 433 medical device local manufacturers and 1911 importers applied for establishment licenses. There are nearly 1400 public and private hospitals serving citizens and foreign patients. The main users of medical devices are public hospitals, while private hospitals play a major role as a hub for medical tourism and medical services for 2 million international visitors each year. It is widely accepted that Thailand is one of the few countries in the world that can provide the best health care for a reasonable cost. Thailand’s hospital infrastructure and upgrading drive for the medical-imaging market was US$ 70 million in 2011 and is expected to reach US$ 100 million in 2015 (the year for emerging ASEAN Economic Community: AEC 2015). 37.2 Medical Device Regulations and
RegulatorsIn Thailand, medical devices are regulated under the Medical Device Act 2008 by the Thai Food and Drug Administration (Thai FDA), Ministry of Public Health. The Medical Device Control Division under the Thai FDA is the key body and has main duties and responsibilities for control of manufacture, import, sale and advertisement of medical devices with the goal to ensure safety, effectiveness and quality of medical devices available to consumers. The Medical Device Control Division has performed activities including pre-marketing control, post-marketing control, pre-and post-advertisement control, standard development, and law and regulation development and has worked with the Bureau of Import and Export Control of the Thai FDA to control the import and export of medical devices in Thailand. The import and export of medical devices must undergo an inspection by Thai FDA staff at the port of checkpoint. The previous and first Medical Device Act 1988 was repealed and replaced by the Medical Device Act 2008, which came into force on March 6, 2008. Medical devices regulated under the Medical Device Act 2008 include medical
devices for both human and animal use, in vitro diagnostic devices and computer software. Any person (natural or legal person) who wishes to manufacture or import medical devices must register for establishment license with the Thai FDA, and the establishment licensee (manufacturer or importer) has to submit for product registration or product approval with the Thai FDA. Once the licensee gets product approval, that medical device can be freely sold throughout the country. At present, sale license is not required except for selling HIV test kits. Thai FDA Good Manufacturing Practice (GMP), which was adapted from the ISO 13485 standard, was introduced in 2005 on a voluntary basis. It is currently compul-sory for HIV test kit manufacturers and will be made compulsory for a wider range of devices in future. An establishment license has validity of five years (until December 31 of the fifth year from the year of issuance) and sale license has validity of one year (until December 31 of the year of license issuance). The act also provides some scope for exemption from medical device premise establishment and product registration requirements (with specific condition and procedure), such as importing necessary amount of medical device for personal use or for exhibition or educational purpose. By law, certain important issues are decided by the Medical Device Committee and Subcommittees. The Medical Device Committee has following powers and duties: • to give recommendations on policies and measures concerning the control of medical devices so as to ensure compliance with the act. • to give recommendations on the issuance of Ministerial
Notifications, • to give approvals for suspension and revocation of an establishment license and product registration.The subcommittees were appointed by the Medical Device Committee, including subcommittee on policy and measure of medical device control, subcommittee on establishment license and sale license, subcommittee on product registration, subcommittee on medical device advertisement, subcommittee on technical issues, subcommittee on standards of manufacture, import and sale of medical devices, and subcommittee on regulation development. Other important rules highlighted from the Medical Device Act 2008 include product liability, technology assessment procedure
for announced particular products, and enforcement of Good Importation Practice (GIP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP). 37.3 Definition of a Medical DeviceA “medical device” means (1) any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article (a) intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of
the specific purpose(s) of (i) using in medical and health professional practices (ii) diagnosis, prevention, monitoring, treatment or alleviation of disease (iii) diagnosis, monitoring, treatment, or alleviation of an injury (iv) investigation, replacement, modification, or support of the anatomy or of a physiological process (v) upporting or sustaining life (vi) control of conception or fertility development (vii) aids or compensation for disability or handicap of human beings or animals (viii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from a human or an animal body (ix) disinfection of medical devices, and (b) which does not achieve its primary intended action in or on the human or animal body by pharmacological, immuno-logical or metabolic means, but which may be assisted in its intended function by such means. (2) apparatus or spare part of instrument, machine, product, or article under (1) (3) instrument, apparatus, machine, product or any other article as specified to be medical device by the Minister of Public Health.
