With affordable healthcare, well-developed healthcare infrastructure, highly skilled medical professionals, and medical services meeting international standards, Thailand is Medical ASEAN Hub. As of August 2023, the Joint Commission International (JCI) accredited 59 Thai medical institutes which offers diverse medical treatments, ranging from organ transplants to dental and cosmetic surgery.
Thailand’s low cost of medical care attracts increasing number of medical tourists. The average medical tourist can expect to save 25 percent to 75 percent on various procedures and treatment options. For example, a heart bypass surgery in Thailand costs $13,000, nearly nine times less than in the U.S. ($113,000). A facelift costs up to $15,000 in the U.S., but as low as $3,000 in Thailand. Hip replacement in Thailand costs about $7,800 compared to $50,000 in the U.S.
In addition to low costs, Thailand has highly trained and experienced medical specialists and is well known for quality service. Thailand has also made impressive strides in the use of advanced technologies and treatment options. Furthermore, the country’s abundant tourist attractions are another major draw for medical tourists.
MEDICAL DEVICE
In 2023, the value of Thailand’s medical device market was approximately $8.2 billion. Owing to global recovery from the COVID-19 pandemic, the local production and export of personal protective equipment(PPE) decreased significantly. As a result, Thailand’s overall production and export of medical devices decreased by 35 percent and 39 percent, respectively. Thailand imported $2.7 billion in medical devices in which medical devices from the United States accounted for 17.2 percent of total imports or $478 million. Thailand imported $784.32 in medical devices from China, followed by $478.34 million from the United States, $218.42 million from Germany, and $163.1 million from Japan. The United States remains the top supplier of higher technological devices such as cardiovascular devices, ultrasound, and X-ray devices, electro-diagnostic devices, etc.
PHARMACEUTICAL
Over 2023 to 2025, the market is expected to continue to grow thanks to the likely ongoing rise in incidences of chronic non-communicable diseases (NCDs), the extension of universal health coverage programs to cover the whole of the Thai population, the increasing number of foreign patients seeking treatment in Thai hospitals, and the rising global concerns with wellness and preventative healthcare that are influencing Thai consumers. Growth will extend through the period 2023 to 2025 and the domestic market should increase in value by an average of 5.0-6.0% per year. By segment, distribution through hospitals will perform slightly better, growing at the average annual rate of 6.3%, compared to the expected 5.0% growth for OTC distribution.
REGULATORY ASPECTS
Before being imported into Thailand, all products (Medical Device or Drugs) must be classified and certified in Thai FDA. Companies without a physical location in Thailand must appoint a Thailand License Holder (TLH) to coordinate the registration of their Medical Device/Drugs with the Thai Food and Drug Administration (FDA). The TLH controls the registration.
LICENSE HOLDER REPRESENTATION FOR FOREIGN MEDICAL DEVICE/DRUGS COMPANIES
- What is the role of a License Holder?
- How can we maintain control of our registrations in Thailand?
- What are the advantages of an independent representative?
Success in Thailand depends on the help of an experienced license holder
The Thai License Holder plays a significant role in the Medical Device/Drugs registration process and carries substantial responsibilities. Your TLH represents your company and products and is identified on your MedicaL Device/Drugs registration certificates (Certificate of Product Approval).
Once the product is approved, your license holder is responsible for annual reporting of imported products and subject to unannounced audits from the FDA. Your TLH must be a licensed Importer, inspect incoming shipments for compliance, assist with customs clearance, and maintain responsibility for the products on the market. TLH must have Thai FDA Import License for Medical Device/Drugs. In addition, for Medicines he must have the Wholesale License and GDP (Good Distribution Practice) for the sale in Hospitals.
Benefits of independent representation in Thailand
Many Thai License Holders are also distributors. Unfortunately, many foreign manufacturers do not realize the license holder controls the original Medical Device/Drugs registration. This can be a big problem if you ever want to switch or add distributors at a later time, because Medical Device Certificates are not transferable. Pharmaceutical Certificates are transferable, but only with the prior authorization of the old License Holder, who often asks for expensive amounts to grant it. Therefore, whenever you want to replace or add some new distributor, you will have to recertify the products in Thai FDA or, in the case of drugs, face excessive costs.
Kha Bangkok/Kha B Group are not involved in product sales and offers independent License Holder services, allowing you to change or add distributors as needed without impacting your registrations.
By appointing Kha Bangkok/Kha B Group as your Thailand License Holder, you maintain control of your intellectual property, distribution channels, and post market vigilance. As your Registration holder, we can:
- Submit product registration application
- Submit MedicaL Device/Drugs Certificate application and assist during on-site audit
- Coordinate Incident Reporting within Thailand
- Act as the primary liaison with the FDA, as required
Common question
Why not choose a distributor as our license holder?
It seems practical to hire a distributor as your TLH. However, choosing an independent representative avoids future complications and conflicts of interest. Here are a few reasons not to choose your distributor for this important role:
- Distribution in Thailand is relatively fragmented, and a distributor’s relationships with buyers are very important. To effectively cover the entire country, foreign firms may need to consider selecting several distributors, each responsible for a separate geographic area.
- Provides flexibility. You won’t be tied to one distributor.
- If your distributor is your TLH, it is nearly impossible to change or add distributors since they control your registrations. In Thailand it is not allowed transfer MedicaL Device Certificates to another distributor.
- Ensures regulatory diligence. Some distributors may not be experienced with or aware of the responsibilities and requirements of a TLH.
COSTS FOR THE MANUFACTURER
- PRODUCTS FDA REGISTRATION FEE: We generally produce a customized quotation based on the type and number of products to be certified in TFDA
- LICENSE HOLDING FEE: It is a fee to be paid monthly for License Holding services (also in this case it depends on the type and quantity of products to be managed). It is generally only required for the first 12 months after marketing. Later, in agreement with the manufacturer, it will be replaced by a small commission on sales in Thailand.
