TFDA

Medical Devices and Thailand Food and Drug Administration (TFDA)

 

Overview

 

At present, almost 70-80% of Medical devices in Thailand are import!ed from abroad e.g. US, Europe, Japan, India, Korea and China. As the domestic industry of medical devices is still not strong enough, new technical and innovation are under development that’s why we mainly rely on import!s.

 

The research from Mahidol, a university of medical at Bangkok, reports on 2009 has shown that there are demands of various types of medical devices. Since expansion of medical services and health tourism program had created, market continuous growth and according to state policy to promote Thailand as a medical hub of Asia, we become the 8th largest market in the developing country to import! medical equipment and our total import!s values is over 20,000 million Baht a year

 

Now the Government was conscious to guidelines and goals for development in the medical industry, much legislation prepared to support competitiveness in international market and reduce import!s.

 

Thailand’s Standard of Medical Devices

parties involved in medical device control is TISI and FDA department

  • Thailand Industrial Standard Institute (TISI) is an organization that play a role in setting a standards of national medical devices
  • Food and Drug Administration (FDA) responding in control and monitoring about  manufacture or import! standardized as prescribed by TISI

In the procedure of manufacturing medical devices, we have national standard of IEC/ISO 13485 as a monitoring and certification of management systems. Moreover, FDA provided Good Manufacture Practice (GMP) standard, rules and procedures in the Manufacturing of Medical devices, it is used to support and help as guidelines in management of quality and to manufacture to provide quality medical devices.

The important subject which must not be skipped is, in order to run a medical device business in Thailand the 1st thing to do is to request for Establishment License from FDA.

 

The Medical Device Act A.D. 2008 requires that any person who wishes to manufacture or import! medical devicesinto the Kingdom must obtain a establish license from the General Secretary of Food and Drug Administration

 

“Import!” means import!ing or ordering into the Kingdom.

 

“Manufacture” means make, assemble, invent, repackage, separately or collectively, improve, modify or sterilize

 

Application and approvals for establishment licenses are to be conducted in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulations.

 

Under monitoring of FDA, medical devices is controlled by a necessary situation, meanwhile the international medical devices is controlled by level of risk also to avoid an illegal activities or penalty, It very important to know the classification of medical devices in Thailand. It is explained in more details as follows:

 

Class I. Licensed Medical Devices

 

Devices those require premarket approval. They are the most stringently controlled class. At present, 7 items are classified into the class as follow:

 

  • Condoms
  • Examination Gloves
  • Surgical Gloves
  • Sterile Hypodermic Disposable Syringes
  • Sterile Insulin Disposable Syringes
  • HIV test Kits for Diagnostic use
  • Contact Lens

 

All manufacturers and import!ers of devices mentioned above must obtain a product license or licenses issued by FDA before manufacturing or import!ing.

 

Class II. Notification Medical Devices

 

This group of medical devices composes of:

 

  • Physical therapy products
  • Alcohol detector
  • Implanted Silicone Breast Prosthesis
  • Breast enhancement
  • HIV test Kits (for researching and Studying) which not for registration

All manufactures and import!ers of devices mentioned above must obtain a product Notification by FDA before manufacturing or import!ing.

 

Class III. General Medical Devices

 

All medical devices which are not mentioned in above classifications of Licensed and Notification, can generally registered to FDA by submitting application and other related documents as required by FDA officer

 

Thailand Food and Drug administration

 

All kind of medical devices that are used in Thailand has to be approved and registered by Food and Drug administration (FDA), it is important organization that monitors & controls various matters related to medical devices and others. The main role of the FDA is to protect consumer’s health, especially, to ensure safety, quality and efficacy of health products within its limit.

 

These include: foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances available in the country. This has to be implemented in accordance with national legislation and international agreements.

 

  1. Pre-marketing control
    • This includes control of manufacturing facilities, product quality and advertising before the products launch in the market. In each case, compliance is required with the relevant legislation and regulations.​​
  2. Post-marketing control
    •  The aim of this activity is to investigate manufacturing facilities and product quality and to ensure that they maintain compliance with previously-approved standards and with legislation and regulations. For example, samples of products are regularly inspected and taken to check for compliance and quality. Previously-approved products are revisited periodically to ascertain the consistency of manufacturing and product standards over time.​​
  3. Surveillance program for consumers' safety
    • The aim of this Program is to detect any adverse effects or unexpected outcomes from consumer use of products. Research and epidemiological data on adverse effects, including technical information, is collected, summarized, interpreted and reported. There are also operational centers, such as the Adverse Product Reaction Monitoring Center (APRMC) and the International Program on Chemical Safety (IPCS). Information is exchanged with other agencies at local and international level.​​
  4. Consumer Education
    • Consumers are supplied with sufficient, accurate information to enable them to choose products wisely. Access to such information, provided by the FDA, is available from many sources: television, radio, newspaper, leaflets, internet, and so on . FDA’s campaigns on priority topics have been regularly conducted in department stores, schools and villages in many parts of the country. There are many sources for consumers to use so that they can obtain further useful information and be in a better position to protect themselves.​​
  5. Technical Support and Cooperation with other agencies
    • The FDA has conducted many interesting seminars and workshops, with participants from both public and private sectors. on the other hand, officials from the FDA are sent to join seminars and conferences, both local and abroad. As a result, with a widened perspective, they can work more effectively at home. The Good Manufacturing Practice (GMP) program is another example demonstrating successful cooperation with other organizations, in this case, with universities and drug manufacturers. In relation to cooperation in terms of research and development, the FDA is continually supportive of such endeavor, and some research projects are partly or wholly funded by the agency.​​
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