Definition and Scope of Medical Devices in Thailand

1. Legal Definition under Thai Law

According to the Medical Devices Act B.E. 2551 (2008), a medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
• Investigation, replacement, modification or support of the anatomy or of a physiological process
• Supporting or sustaining life
• Pregnancy control
• Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body https://en.fda.moph.go.th/entrepreneurs-medical-devices/category/what-are-medical-devices/

This definition aligns closely with international standards such as those of the International Medical Device Regulators Forum (IMDRF) and the EU Medical Device Regulation.

2. Key Exclusion Criteria

Products are not considered medical devices if their principal intended action is achieved by pharmacological, immunological, or metabolic means. Such products fall under the drug/pharmaceutical regulatory framework instead. Borderline cases may be evaluated on a case-by-case basis by the Thai FDA. https://en.fda.moph.go.th/entrepreneurs-medical-devices/category/what-are-medical-devices/

3. Examples of Medical Devices

The website provides illustrative examples across various categories:

• Simple/low-risk — Bandages, surgical gloves, manual surgical instruments, wheelchairs, spectacles
• Moderate-risk — Blood pressure monitors, contact lenses, infusion pumps, diagnostic ultrasound devices
• High-risk — Pacemakers, heart valves, implantable defibrillators, coronary stents
• In vitro diagnostics — Blood glucose test kits, pregnancy tests, HIV rapid tests, PCR reagents for infectious diseases https://en.fda.moph.go.th/entrepreneurs-medical-devices/category/what-are-medical-devices/

Software intended to perform a medical purpose (e.g., diagnostic algorithms) is also classified as a medical device.

4. Regulatory Implications

The broad definition determines whether a product falls under medical device regulation, which includes:

• Risk-based classification (Class 1 to 4)
• Licensing of establishments
• Product registration/notification
• Conformity assessment requirements
• Labeling and post-market surveillance obligations https://en.fda.moph.go.th/entrepreneurs-medical-devices/category/what-are-medical-devices/

Products meeting the definition but intended solely for research or non-clinical use may qualify for exemptions or special pathways.

5. Borderline and Combination Products

The Thai FDA assesses combination products (e.g., drug-device or biologic-device combinations) based on the primary mode of action. If the device component is principal, it is regulated as a medical device; otherwise, it may fall under pharmaceutical regulations. https://en.fda.moph.go.th/entrepreneurs-medical-devices/category/what-are-medical-devices/

6. Importance for Manufacturers and Importers

Understanding whether a product qualifies as a medical device is critical for determining the correct regulatory pathway, licensing requirements, and compliance obligations in Thailand. Misclassification can lead to enforcement actions, import refusals, or product recalls. https://en.fda.moph.go.th/entrepreneurs-medical-devices/category/what-are-medical-devices/

The Thai FDA’s clear definition and examples help stakeholders navigate the regulatory landscape effectively while ensuring patient safety. https://en.fda.moph.go.th/entrepreneurs-medical-devices/category/what-are-medical-devices/