Lalida revealed that the government is raising the standards for medical devices, requiring clear labels and accompanying documents that are safe and not exaggerated, with the new criteria to begin on 20 June.
On 15 June 2026 GMT+7, Ms. Lalida Pertwiwatthana, Deputy Spokesperson of the Office of the Prime Minister, stated that the government under the leadership of Prime Minister and Minister of Interior Anutin Charnvirakul prioritizes the safety of the public in using health products. The Ministry of Public Health has revised the criteria for labeling and accompanying documentation of medical devices to be clear, modern, and appropriate for current use, effective from 20 June 2026 GMT+7.
The Deputy Spokesperson explained that the new criteria require manufacturers, importers, licensees, or registrants of medical devices to provide labels and accompanying documents that are clearly legible, complete in information, and must not contain false, exaggerated, or misleading claims that could confuse the public.
For medical devices intended for general public use, such as those used at home, labels and accompanying documents must be in Thai. Medical devices used by medical and public health professionals may have labels in either Thai or English, provided they are understandable. Important information must be included, such as product name, intended use, instructions, warnings, contraindications, precautions, name and address of manufacturer or importer, batch number, manufacturing date, expiration date, or service life.
Additionally, the announcement supports displaying accompanying documents electronically, such as via QR codes, websites, or digital channels, to facilitate easier access to information for the public and healthcare personnel. It also sets guidelines for software-type medical devices, applications, accessories, and dental instruments to ensure verifiable information and safe usage.
Ms. Lalida stated that these measures will help enhance consumer protection, reduce risks from improper use of medical devices, and increase confidence in Thailand’s medical device regulatory system. At the same time, they provide clear standards for operators in manufacturing, importing, and selling products.
Labels or accompanying documents for medical devices made under the previous criteria before the new announcement take effect may continue to be used for up to two years from the effective date to allow operators time to adjust. The government affirms it will continue to carefully regulate health products to ensure the public has access to quality, safe medical devices with accurate and complete information.