The Kingdom of Thailand, a country with a population of well over 65 million people, acts as a regional hub in Southeast Asia. Along with countries like Malaysia and Indonesia, it is considered a relatively new hot spot for investment and sale of medical devices. Thailand is an active participant in the Asian Harmonization Working Party and the ASEAN Consultative Committee on Standards and Quality.

The Thai government is working to improve and accelerate R&D for medical devices and has assigned the Board of Investment (BOI) to offer incentives to both Thai and foreign investors in the form of tax breaks and land ownership. Growth of the Thai market is further supported by the National Metal and Materials Technology Centre (MTEC), which aims to strengthen development of high-demand materials and equipment.

In order to manufacture, import, or sell a medical device in Thailand, it is crucial for medical device companies (manufacturers, importers and sellers) to fully understand the applicable local regulations. These are controlled by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA).

THE GOOD NEWS:

It is possible to register a range of medical devices in Thailand in timely manner.

THE GREAT NEWS:

Low-risk devices can obtain sales and market clearance in 7 to 10 working days.

The medical device market in Thailand consists of mainly imported products (66%), most of which go to hospitals. Along with many other Asian countries, Thailand is working on harmonization efforts through the Asian Harmonization Working Party (AHWP).

Pre-approval of all medical devices is required before any commercial activity begins. It is also important to note that only locally established companies can import and register medical devices in Thailand.

The Thai authorities (TFDA) divide medical devices into three categories: licensed medical devices (Class I), notification medical devices (Class II), and general medical devices (Class III). A local authorized representative is required for the registration of all three types. The classification system in Thailand ranks the risk of devices in reverse order; thus, a Class III device is the lowest risk and Class I is the highest risk. Usually, a device is classified depending on whether there are any medical treatment claims and/or whether the products are sold to doctors.

Class III medical devices do not require a license, but the applicant must submit a Certificate of Free Sale (CFS) from either the USA, the EU, Japan, Australia, or China. The requirements for this category are much less stringent and only the product description/information, the catalogue, and the CFS are required. If the product is a sterile product, a certification ISO 13485 is also needed. Registration is completed in a minimum of 7-10 working days.

For Class II medical devices, including HIV test kits (for purposes other than diagnostic), physical therapy products, alcohol level detectors, and implanted silicone breast prosthesis and breast enhancements, notification must be submitted to the TFDA. These devices are processed in a minimum of 90-120 working days.

Class I devices, including condoms, examination gloves, surgical gloves, sterile hypodermic syringes, sterile insulin disposable syringes, contact lenses, and HIV test kits (for diagnostic purposes only), require that a license be obtained from the TFDA. Class I devices may also require a Certificate of Analysis from the Department of Medical Sciences. The timeframe to obtain licenses for Class I devices is a minimum of 90-120 working days.

All medical devices sold in Thailand must be labeled in Thai. Cost per registration usually ranges from below USD $100 for Class III (low risk) devices to USD $700.

The TFDA requires that the manufacturer or an authorized representative register the device in person through a locally-based legal entity. It is usually takes approximately 30 working days for registration from submission to approval, which is valid for up to two years unless the Thai representative or distributor is changed, in which case the new representative must re-register the product for marketing and sale to continue.

WHAT YOU NEED TO KNOW:

The Thai authorities classify devices in reverse order from many other authorities. Class I (highest risk) and Class II devices require a certificate of free sale and are processed in 90-120 working days. Class III (lowest risk) devices are processed in 7-10 working days with minimal cost and only basic information is required.