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Healthcare Resource Guide: Thailand

 

Thailand Statistics

Summary Market Entry
Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement
Barriers

Trade Events

FAQs

CS Contact

Best Prospects

Capital: Bangkok

Population: 68.75 million

GDP*: $406.9 million
(3.2% growth over 2015)

Currency: Thai Baht

Language: Thai

Summary

Thailand is considered to be a top destination for medical tourism in Southeast Asia. In 2016, medical tourists coming to Thailand accounted for 38% of such visitors to Asia, and the country’s medical tourism grew 14%. The Thai government announced a ten-year strategic plan (2016-2025) which aims to develop and consolidate economic sectors as a hub for wellness and medical services. It further envisages four interweaving strands of related activities: wellness (including preventive treatments), provision of medical services, outputs from academic research, and medically-related products such as vaccines, medical technology, and equipment.

Thailand already has a large healthcare sector that is a leading priority of the Thai government. Within ASEAN, Thailand has the highest spending on healthcare (14% of the government budget). Thailand has long been a destination for international patients, due to its high-quality medical facilities, well-trained medical professionals, competitive prices, and well-developed tourism infrastructure; Thailand has 1,007 public hospitals, 341 private hospitals, 50,573 trained physicians, 11,575 dentists, 158,317 nurses, 15,200 medical technologists and 10,065 physical therapists. As of July 2017, Thailand ranked 4th in the world with 58 hospitals certified by the Joint Commission International (JCI).

Market Entry

U.S. manufacturers of healthcare products should work with qualified local distributors/representatives. Local agents will provide immediate access to an established marketing network and in-depth knowledge of regulations. A critical role of local representatives is to provide after-sales service support to customers and to develop and maintain strong personal relationships with customers. In Asia, relationships play a key role in business and greatly influence customers’ procurement decisions.

An agent's role includes all marketing of the products and as well as product registration with Thailand’s Food and Drug Administration (FDA), which is required prior to any importation of medical devices, pharmaceuticals, and food supplements.

Current Market Trends

The health services segment of the tourism industry is growing. Medical tourism contributes up to 0.4% of Thailand’s GDP, while tourism overall accounts for around 6% to 7%, and it is considered the third most important economic driver in Thailand. According to Kasikorn Research Center, medical tourism could have generated as much as $3 billion in 2015 and this represented revenue growth of 15% year-on-year. In-line with this growth, foreign investment in Thailand’s health sector is also increasing. Stronger interests from foreign investors (Japan, Malaysia and Singapore in particular) should spur locally-based service providers, which will need to work harder to maintain their competitive edge in the market as the segment is expected to consolidate in a bid to expand its reach.

Thai medical practitioners are recognized for their specializations. Private hospitals are equipped with latest medical facilities and patients do not have to wait to obtain the treatment. Healthcare services in Singapore costs three times and Malaysia costs two times more than Thailand. It is forecasted that there will be four million medical tourists visiting Thailand in 2017. Popular healthcare services among medical tourists include cosmetic surgery, dentistry, cardiovascular diseases and orthopedics.

According to the survey by Global Wellness Institute, Thailand’s cosmetic surgery ranks 8th in the world because the healthcare services by Thailand’s private hospitals are equivalent to those in U.S.A. and Europe. The cost of nose cosmetic surgery in Thailand is two times lower than in U.S.A. The cost of sex reassignment surgery in Thailand is ten times lower than in U.S.A. and Europe.

Thailand attracted approximately 2.5 million international patients in 2015. Many of these patients stayed on afterward for a holiday, either in Bangkok or at one of the country’s beach resorts. More than one-third was from the Middle East. While low oil prices have led to decreases in numbers of medical tourists from the Gulf region in recent quarters, the shortfall is made up by the growth of wealthy medical tourists from neighboring countries such as Myanmar and Vietnam which have less-developed health care systems. As part of the promotional plans, the staying period for medical treatment for patients from China, Laos, Cambodia, Myanmar, and Vietnam has tripled to 90 days.

As a result of the growth in healthcare services, Thailand’s medical device market is expected to grow at least 10% in 2017 and was valued at $1.259 billion in 2016. Imports of medical devices increased by 10.4% and exports of medical devices increased by 7% in 2016, reflecting steady growth in Thailand’s healthcare sector despite the global and domestic economic downturn. As a market leader, U.S. device makers provide approximately one-fourth of the imported medical devices. There are over 160 local manufacturers of medical devices; most are lower-end devices such as disposable test kits and syringes, as well as latex products including surgical gloves and catheters. Over 80% of domestic production is exported.

The population of aging people in Thailand is increasing. According to Siam Commercial Bank PCL's Economic Intelligence Center, Thailand has approximately 11 million “elderly people” (16% of total population). It is forecasted that by 2031, approximately 19 million or 28% of Thailand's population will be over the age of 60, and by 2050, the number will rise to 33%. Thailand’s aging population is a major catalyst of the demand for healthcare services.

Due to the aging population and health-conscious trends, Thailand estimates the sales value of dietary supplements reaching $1.7 billion in 2018. Likewise, the pharmaceutical market in Thailand is expected to increase from $5.91 billion in 2015 to $9.47 billion by 2020. Overall revenue of private hospitals targeting international patients will expand 10% to 12% in 2017, which is higher than private hospitals that focus entirely on the domestic market that are likely to achieve a revenue growth rate of 7% to 9%.

Main Competitors

American products are the leaders in the high-end medical device market, clinical diagnostic laboratory, and biotechnology. They face strong competition, however, from European and Japanese companies.

Current Demand

Medical devices with the best growth opportunities include surgical procedure equipment, diagnosis equipment, and devices for lung and heart disease treatment. Examples include respiratory devices, orthopedic implant devices, heart valves, and neurosurgical devices. The dermatological device market also has good potential, as standalone skin care and dermatological clinics have become very popular in the recent years. Some of Thailand’s beauty clinic chains have also expanded to neighboring countries like Cambodia, Laos, Myanmar and Vietnam. Products for the elderly such as home-use blood pressure monitors, blood glucose meters and wheelchairs will be in demand. From 2011 to 2015, herbal and natural dietary supplements enjoyed the growth of 13%.

Registration Process

The Thai Food and Drug Administration (FDS) is responsible for the protection of the consumer’s health and safety by ensuring the quality and efficacy of health products. The FDA thus controls the following products on the Thai market (manufactured or imported): foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances. An FDA-approval will be required in case you want to manufacture or import any of those products.

  • Drug Registration

Application for the Certificate

1. Permission to import or manufacture a drug sample in order to have it registered

The following documents are required: a completed application form, the drug formula, the drug literature and the drug labeling and packaging.

2. Application for the approval of granted credential certificate

In this case, a lot more information has to be provided:

  • Completed application form
  • Permit to manufacture or import drug sample (see above)
  • Drug sample
  • Pharmacological and toxicological study (if any)
  • Clinical trials, safety and efficacy study (if any)
  • Complete drug formula
  • Drug literature
  • Final labeling and packaging including the registration number, quantity of drug per packaging, name of manufacturer and address, manufacturing date, the expiry date…
  • Legalized (by the authorized officer) and by the Thai Embassy endorsed certificate of free sale (in case of imported drug)
  • Manufacturing method
  • In-process control with the relevant acceptable limits
  • Raw material specifications of active(s) and inert ingredients with the corresponding control methods in details
  • Finished product specification with the corresponding control methods in details
  • Certificate of analysis of active ingredient(s)
  • Drug analytical control method
  • Packaging
  • Storage conditions
  • Stability studies of the finished product
  • A certificate of GMP (in case of imported drug)

It normally takes minimum two years to register a pharmaceutical product with Thai FDA.

In December 2016, Prime Minister of Thailand invoked Article 44 under the interim constitution to establish a panel to oversee national reform agencies which will ensure their work does not overlap. He will also exercise Article 44 to fast-track drug registration with the Food and Drug Administration (FDA). The order aims to help process the registration of thousands of drug lists with the agency as the lists had been put on the back-burner under several governments. The drug registration move will help Thais buy drugs at lower prices as well as boost the herbal medicine industry. Since FDA is short of staff to examine a number of products for approval, the order will allow the FDA to collect additional fees from those operators to hire experts from both Thailand and overseas to examine the products.

On 8 March 2017, the Secretariat of the Cabinet called a meeting of stakeholders to share concerns on the Cabinet and National Council for Peace and Order (the NCPO) applying Article 44 of the 2014 Interim Constitution to clear the backlog of unexamined patent applications in Thailand.

FDA Drug Control Division: http://www.fda.moph.go.th/eng/drug/index.stm

  • Food Supplement Registration

Prior to starting the registration process for a food product, the Thai FDA must first approve all ingredients of the products. An ingredient that is commonly registered in another country may not necessarily have been registered with the Thai FDA. For new ingredients, the FDA will request additional supporting documents. For example, a product used in food consumption must be able to show a history of use for more than 15 years in a foreign country and/or safety data. Companies need to make strategic decisions about whether to retain the new food ingredient in a formula. On the one hand, the new ingredient can be helpful in differentiating the product from competitors, but, on the other hand, companies face an extended registration process when new ingredients are included.

Prior to FDA submission, an applicant must provide (1) the ingredient list for its products; (2) the source of the ingredients; (3) the manufacturing process; (4) the objectives of use; and (5) the targeted consumer group.

To register with Thai FDA, following documents and information are required:

  • Two samples of each product
  • Details of the exact composition by percentage of each ingredient
  • A production flowchart
  • Six labels

The products must display the following information for consumers:

  • Name and brand of the product (both generic and trade)
  • Registration number
  • Name and address of the manufacturer
  • Name and address of the importer
  • Manufacturing and expiry dates
  • Net weight and volume
  • Any additives used
  • Health and nutritional claims

A health supplement is classified as a food supplement if it contains common herbal ingredients or other bioactive ingredients at a daily dosage level recognized by the Thai FDA as safe for food. For common vitamin and mineral supplements, the levels of the nutrients must be kept between 15–100% of the Thai Recommended Daily Intake (RDI) in order to be classified as a food supplement.

In terms of bearing nutritional claims, such as nutrient content or comparative nutrient claims, health supplements regulated as food supplements are permitted to bear claims that are in line with the Codex Alimentarius nutrition labelling guidelines. For claims pertaining to functions of nutrients (e.g. vitamin A for night vision, calcium for healthy bones), food supplement products are permitted to bear claims that are in the Thai FDA’s permitted list of nutrient function claims for conventional food.

It is important to note that, as a member of the Association of South East Asian Nations (ASEAN) working group on the harmonization of health supplements and traditional medicine, the Thai FDA is in the process of reviewing its regulatory framework for evaluating the substantiation of health claims. Food supplements are not permitted to bear medicinal claims, unless the product is registered as a traditional medicine or drug.

Health supplements containing ingredients not approved as food ingredients and/or containing vitamins and minerals that exceed the Thai RDI value must be registered as traditional medicines, drugs or any other related sub-categories, such as modern herbal drugs, generic drugs, or new drugs. Glucosamine, for example, is considered a generic drug, whereas as echinacea is considered a traditional medicine.

Products classified as food supplements require a notification process.

In general, it takes approximately six months to register food/health supplements with Thai FDA. Food import licenses must be renewed every 3 years.

FDA Food Control Division: http://www.fda.moph.go.th/eng/food/index.stm

  • Medical Devices Registration

The Medical Device Control Division under the Thai FDA oversees medical device regulation enforcement. The classification of Thai FDA (Class 1, 2, and 3) is reverse of the U.S. FDA (corresponding to Class III, II and I respectively below).

Class 1: Licensed Medical Devices

This is the most rigorously controlled class, comprised mainly of condoms, HIV diagnostic kits, contact lenses, and so on. The following details for these medical devices must be submitted to the FDA:

  • Certificate of free sale
  • Certificate of quality system of manufacture, for example, the relevant ISO certificates
  • Clinical evaluation
  • Sterility
  • Stability
  • Raw material and finished product specifications
  • Thai label and leaflet
  • Product photo
  • Manufacturing process

The FDA requires an applicant to use the ASEAN Common Submission Dossier Template (CSDT) for the technical document requirements for submission of licensed medical devices.

Class 2: Notification Medical Devices

The level of control in this class is less stringent than class 1. Examples of medical devices in this class include physical therapy products, silicone breast implants, and alcohol detectors. The documents required for submission to the FDA are similar to those of class 1. An applicant must prepare the dossier according to the CSDT.

Class 3: General Medical Devices

This class is subject to the least stringent control by the FDA. All medical devices which are not classified as class 1 or class 2 fall in this class. The required documents are:

  • Certificate of free sales from the country of product owner
  • Catalogue/product photo.
  • Specifications.
  • ISO 13485 (in some human use product categories, for example implant products and sterile products).

Time frame: The approval process after file submission takes about eight to ten months for Class I devices, six to eight months for Class II devices, and up to ten days for Class III devices.

The Thai FDA plans to re-classify medical devices based on the level of associated risk to comply with the ASEAN Medical Device Directive.

FDA Medical Device Control Division:

http://www.fda.moph.go.th/eng/medical/index.stm

U.S. Commercial Service’s Certification and Legalization Service

Foreign medical device companies wishing to sell their products in Thailand must first register themselves according to the risk-based classification system. The authenticity of the ensuing Certificate to Foreign Government must then be attested to by U.S. Commercial Service in Bangkok.

Our office facilitates the certification and legalization of documents as required by Thai FDA. The standard timeframe for completing a certification service is three business days from the date of documents submission.

For more information about our certification letter service, please see more details from our website:

http://2016.export.gov/thailand/services/certificate/index.asp

Reimbursement

The key development in the Thai healthcare system occurred 2001, when the introduction of a universal healthcare program, known as the “30 Baht” (THB 30, or approximately USD 1) scheme, was initiated. Under this scheme, patients may visit public hospitals and pay only THB 30 per visit, with the remaining costs of the treatment being subsidized by the government. The THB 30 scheme provides basic healthcare coverage to approximately 47.7 million Thais.

The Social Security Scheme (SSS), administered by the Social Security Office, was initiated to assure benefits for insured employees to relieve their difficulties, including sickness, maternity, physical disability, unemployment, death and old-age pension. This scheme is financed by tripartite contributions from the government, employers and employees. The Social Security Scheme covers about 10.4 million private sector workers and is based on an employer contribution system.

Civil Servant Medical Benefit Scheme (CSMBS), is a medical service welfare system for civil servants and state enterprise employees and their dependents (including spouses, up to three children, and parents). The budgets of the government and state enterprises are the sources of funding. The Civil Servant Medical Benefit Scheme provides healthcare benefits to approximately 4.9 million government workers.

The rest of population are those who do not intend to use the benefits described above pay medical expenses himself/herself or via private voluntary health insurance.

Barriers

Thailand has rigorous regulatory requirements and lengthy product registration. Dealing with the regulatory requirements is a major challenge for foreign companies that wish to export into Thailand. Therefore, it is important to seek the right local partner and distributor who have expertise and experiences in processing product registration and dealing with Thai government agencies.

Procurement & Tenders

Healthcare Procurement: http://ops.moph.go.th/public/index.php/announce

Trade Events

Medical Fair Thailand 2017

Date: 6-8 September, 2017

Venue: Queen Sirikit National Convention Center

Website: http://www.medicalfair-thailand.com/index.php/en/

Thailand Lab International 2017

Date: 6-8 September, 2017

Venue: Bangkok International Trade and Exhibition Centre (BITEC)

Website: www.thailandlab.com

FAQs

Q: What are Thailand’s regulatory requirements that the U.S. healthcare manufacturers should be aware of?

A: The Thai FDA under the Ministry of Public Health is responsible for issuing licenses to importers and producers of medicines, food supplements, medical devices, as well as other potentially toxic substances, so that those products can be imported and sold in Thailand. Therefore, anyone intending to import such products into Thailand needs to obtain a product registration license from the FDA. The Thai FDA also has the authority to control product advertisements, ensuring that the claims made by producers are backed by proper evidence and studies.

Q: Whereas USFDA do not classify some healthcare products as medical devices, the products are regarded as medical devices by Thai FDA. Consequently, they do not have USFDA Certificate to Foreign Government, required by Thai FDA for product registration. Will Thai FDA accept other documents?

A: Yes, Thai FDA usually accepts Certificate of Free Sale, issued by State, Chamber of Commerce and Association located in the U.S.

Q: If an American medical device had received a CE mark but has not yet received a USFDA approval, can it be sold to Thailand?

A: No, it cannot. To register with Thai FDA, the medical devices must first get an approval from the country’s authority of the product owner. Therefore, if product owner is based in the US, it must have a USFDA approval.

U.S. Commercial Service Contact Information

Name: Ms. Kornluck Tantisaeree

Position: Commercial Specialist

Email: ktantisa@trade.gov

Phone: (66)-2-205-5242

Best Prospects

Medical devices

  • Cardiovascular
  • Clinical diagnostics
  • Cosmetic surgery
  • Dentistry
  • Dermatology
  • Neurological surgery
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Rehabilitation
  • Respiratory

According to the statistics of Ministry of Public Health, cancer, stroke, pneumonia, heart disease, diabetes, hepatitis, respiratory diseases, tuberculosis and HIV/AIDS, respectively, are top causes of death for Thais. Pharmaceuticals or medical supplies for the treatment of these diseases will be in demand.


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