Medical Device Market In Thailand With a value of US $1.29 billion, the growth rate in the medical device market in Thailand was 7.5% in 2011 and grew to 8% in 2014. The major medical supplies in Thailand are diagnostic imaging products, medical consumables, orthopedic implants, dental products and auxiliary equipment.
Before 1988, medical devices were regulates as drugs. In May 1988, the Medical Device Act 1988 (effective date: 6 March 2008) was enforced and the Medical Device Control Division, Food and Drug Administration was officially established in June 1990 as regulatory authority to control manufacturing, importing, selling and advertising of medical devices in Thailand.
As per Thailand Food and Drug Administration (Thai FDA), medical device definition is ‘The medical devices must not achieve its primary intended action in or on the human or animal body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means’. They include those for animal use, IVD products, software, accessories, components or parts of medical devices and any products announced by the Minister to be medical devices.
Various Stages where Medical Devices Are Controlled by Thailand Food and Drug Administration (Thai FDA)
Pre-Market Approval Control at port by Thai FDA inspectors with close relation with custom officers Advertisement controlPost marketing surveillance and vigilance Communication of risk information to the public
Pre Market Approval by Thailand Food and Drug Administration
There are three categories of medical devices in Thailand: each with different regulatory requirements. The basic requirement in all cases is the Free Sale Certificate, product Catalogues, Instructions for use (IFU), Quality Management Certificate, ISO 13485. Additional document requirements include clinical data, Certificate of analysis (COA), Batch Release, Product specifications etc.
The classification system by Thai FDA is reverse of the US FDA with Class I devices having the highest risk. They are referred as “general devices” and Class II referred as “notification”. Additionally, import of used / refurbished equipment is prohibited in Thailand. Also it is compulsory to have the Certificate of Free Sale in the Country of origin.
Class I “Licensed” Devices: Thai Class 1 devices need a license for sale in Thailand. They must show compliance with Thai Industrial Standards and in certain cases undergo testing by the Thai FDA. Products in this category include syringes, contact lens, surgical gloves and IVDs.
Class II “Notification” Devices: Thai Class 2 has to be registered with the Thai FDA. However, they do not need to go through the license process. Manufacturer must submit details on content, production process, labeling etc. Thai FDA’s Class II includes silicone implants, blood alcohol measuring kits and rehabilitation devices.
Class III “General” Devices: products which are not covered by Class I and Class II are the general medical devices and have to just be validated by the Thai FDA. Following this an import license must be obtained. This covers about 90% of medical devices.
- Class I: eight to ten months
- Class II: six to eight months
- Class III: two to six days
- Class I and Class II medical devices: five years
- Class III devices: Dependent on validity of the Free Sale Certificate
Post-Marketing Control of Medical Devices
- Premise regular inspection
- product sampling check, recalling system
- Cease production, importation and distribution
- AE reporting and vigilance system
- law enforcement
- public education and awareness
Main Documents for Import License by Thailand Food and Drug Administration
- Free Sale Certificate from country of manufacturer
- Good Manufacturing Practice (GMP) Certificate from the country of manufacture
- Company’s Commercial Registration document
- Company’s establishment documents
Labeling Requirements by Thailand Food and Drug Administration
The labels must be in Thai and include:
- Name, category, and type of medical device
- Name and location of the manufacturer or importer,
- Instructions for usage and storage
- Warnings and precautions
- License number