Bangkok: The government is set to enforce stricter labeling regulations for medical devices, with new directives coming into effect on June 20th to prioritize clarity, safety, and avoid exaggerated claims.
According to Thai News Agency, Deputy Spokesperson for the Prime Minister's Office, Ms. Lalida Periswiwatana, announced that under Prime Minister and Minister of Interior Anutin Charnvirakul's leadership, public safety in health product usage is a top priority.
The Ministry of Public Health has revised guidelines for the labeling and accompanying documentation of medical devices to ensure they are clear, up-to-date, and suitable for current use. The new regulations, effective from June 20, 2026, will require manufacturers, importers, licensees, or registrants of medical devices to provide clearly legible labels and documentation with complete information, devoid of false, exaggerated, or misleading claims that could mislead the public.
For medical devices intended for general public use, such as home-use medical devices, labels and accompanying documentation must be in Thai. Devices for medical and public health professionals, however, can have information in Thai or easily understandable English, including essential details like product name, intended use, instructions for use, warnings, and other vital information.
Additionally, the announcement supports displaying accompanying documents in electronic formats, such as QR codes, websites, or digital channels, to facilitate easier access for the public and medical personnel. This includes guidelines for medical devices in software, applications, accessories, and dental instruments to ensure they contain verifiable information and are used safely.
Ms. Lalida emphasized that these measures aim to enhance consumer protection, reduce misuse risks, and bolster confidence in Thailand's medical device regulatory system. Simultaneously, they help businesses establish clear standards for production, import, and sale of medical devices. Existing labels or documents produced under the old regulations will remain valid for up to two years from the new regulations' effective date, allowing businesses time to adjust.
The government remains committed to regulating healthcare products meticulously to ensure public access to quality, safe medical devices and the provision of accurate and complete information.