Navigating Thailands Medical Device Market

Navigating Thailand’s Medical Device Market

Ames Gross

Despite the horrible flooding in Thailand recently, the medical device market continues to grow. The market currently is valued at $1.6 billion and is growing at about 10 percent per year. As

Thailand continues to develop, the population’s healthcare demands will increase, and the size of the device market will continue to grow.

Market expansion primarily will be driven by upgrades to existing healthcare facilities. Although public hospitals remain the largest purchaser of medical devices in Thailand at about 60 percent of total

purchases, private hospitals in particular increasingly are looking to acquire cutting-edge medical equipment to enhance their existing facilities.

With about 66 percent of the total device market made up of imported medical devices and equipment, Thailand is dependent on imports for facility upgrades. This especially is true for high-end, sophisticated medical devices. Locally manufactured medical devices tend to be less sophisticated and more labor intensive and include surgical latex gloves, disposable syringes, orthopedic accessories, and disposable test kits.

Currently, the best prospects for medical devices in Thailand tend to be those used in the diagnosis or treatment of heart and lung disease, as well as equipment used in surgical procedures.

The devices with the highest demand include heart valves, respiratory devices, neurosurgical devices, diagnostic testing devices, orthopedic implant devices, and disposable diagnostic test kits. Demand for dermatological devices also is expected to grow. The number of dermatological clinics in Thailand has grown dramatically as skin care becomes increasingly popular in Thailand.

Medical Device Classifications

The Medical Device Control Division of the Thai Food and Drug Administration (FDA) is responsible for the regulation of medical devices in Thailand. Medical devices in Thailand are broken down into three classes: Class I, II and III. However, unlike the U.S. Food and Drug Administration, the classifications are reversed. Class 1 medical devices are the most regulated and Class 3 medical devices are the least regulated.

Class I medical devices are called “License” medical devices because they are the only medical products requiring full registration with the Thai FDA before manufacture or sale in Thailand. For example, seven devices are listed by the Thai FDA under the Class I category. They include HIV test kits for diagnosis, insulin disposable syringes, contact lenses, examination gloves, and surgical gloves.

Class II medical devices also are clearly listed by the Thai FDA regulations. The five medical devices currently regulated as Class II products include HIV test kits for research and study, breast enhancement products, alcohol detectors, implanted silicone breast prosthesis, and physical therapy products. The Thai FDA calls this category of medical devices “Notification” medical devices because they do not require full registration, but the Thai FDA needs to be notified with the appropriate documents prior to marketing or importing.

If a medical device is not one of the products specifically mentioned in Class I or II, it will fall under Class III, regardless of risk. Because the Thai FDA provides an official list (with only a limited number of devices) of specific Class I and II medical devices, most medical devices in Thailand will be classified as Class III products. Class III medical devices are “General” medical devices and do not require full product registration in Thailand.

Product Registration

The requirements for registration of imported medical devices in Thailand depend on the classification of the device. For example, to sell Class III medical devices in Thailand, the Thai FDA requires a local entity, a general import license, and a product specific import license.

A local entity with its business registered with the Thai government can be a foreign device manufacturer’s subsidiary, a distributor, or an independent third party.

The general import license is a government issued license that allows a local entity to import all kinds of general medical devices into Thailand. Many companies, consultants and distributors in Thailand already have a general import license, so foreign medical device companies (those without an office in Thailand) most likely will not have to obtain this license themselves.

The product-specific import license allows an importer to bring a specific product into Thailand. For applications to the product-specific import license, the Thai FDA requires documents such as the

Certificate of Free Sale, a company’s commercial registration, a Certificate ofIncorporation or Partnership stating the company’s objectives, etc. Implanted Class III medical devices also will need to include a GMP (good manufacturing practices) certificate or an ISO 13485 certification in their product-specific import license application.

A Certificate of Free Sale/Certificate to Foreign Governments submitted to the Thai FDA for the product specific import license should indicate the product is allowed to be sold in the manufacturing country, include the name of the manufacturer, and list the name of the medical device with information such as its model, type or product code.

If all the documents discussed above can be submitted in perfect condition, the product-specific import license can be received in only one day. However, the Thai FDA often will place a request for missing or supplementary documents if it finds that required documents are faulty or not included in the application.Thus, it normally takes the Thai FDA approximately three to five months to issue the product-specific import license.

Once a manufacturer or the legal agent has obtained the product-specific import license from the Thai FDA, the department will notify the Thai Customs Department to permit clearance of the Class III “General” medical device when it arrives in Thailand.

Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asia market. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988. For more information, visit www.pacificbridgemedical.com.