Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical devices according to risk-based classification.
ThaiFDA is currently in a transition phase from policy-based classification to risk-based classification of medical devices. Currently, medical devices are classified according to the level of risk that may cause harm or impact on public health. Policy based classification comprises of Class I (Licensed Medical Devices, highest class), Class II (Notification Medical Devices), and Class III (General Medical Devices).
Since Thailand has aligned with the ASEAN AMDD, the medical device risk classification will adhere to guidelines on risk classifications as outlined by the AMDD. So, following the complete transition, ThaiFDA will no longer categorize medical devices by their common names and use policy-based classification. The devices shall apply under medical device to be licensed classification includes:
- 1. All surgically invasive medical devices intended for transient use.
a. They are intended specifically for use in direct contact with the central nervous system.
b. They are intended specifically to diagnose, monitor, or correct a defect of the heart or the central circulatory system through direct contact with these parts of the body.
- 2. All surgically invasive medical devices intended for short-term use.
a. They are intended to have a biological effect or to be wholly or mainly absorbed.
b. They are intended specifically for use in direct contact with the central nervous system.
c. They are intended specifically to diagnose, monitor, or correct a defect of the heart or the central circulatory system through direct contact with these parts of the body.
- 3. All implantable medical devices, and long-term surgically invasive medical devices.
a. They are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system.
b. They are intended to be life supporting or life sustaining.
c. They are intended to be active implantable medical devices.
d. They are intended to have a biological effect or to be wholly or mainly absorbed.
e. They are intended to administer medicinal products.
f. They are intended to undergo chemical change in the body except if the medical devices are placed on the teeth.
g. They are breast implant.
- 4. All medical devices with drug combination.
- 5. All medical devices manufactured from or incorporating.
a) animal cells, tissues and/or derivatives thereof, rendered non-viable, or
b) cells, tissues and/or derivatives of microbial or recombinant origin.
- 6. All medical devices used for contraception or the prevention of the transmission of sexually transmitted diseases.
- 7. All IVD medical devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs in order to assess their suitability for transfusion or transplantation.
- 8. All IVD medical devices intended for detecting the presence of an erroneous result would cause death or severe disability to the individual or intended for determining infective disease status or immune status, and where there is risk that erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for patient.
The decree has been implemented starting from April 28,2020 onwards.
Attachment of Ministry of Public Health’s Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Follow for Licensed Medical Device Registration 2020
Rules Procedures and Conditions
HIV Test Kits
Must comply with Ministry of Public Health Announcement regarding HIV Test Kits dated on November 2nd, 2009
Must comply with Ministry of Public Health Announcement regarding HIV Self-testing 2019 dated on March 19th, 2020
Injectable Hyaluronic Acid
Must comply with Ministry of Public Health Announcement regarding Injectable Hyaluronic Acid 2019 dated on August 9th, 2019
Implanted silicone breast prosthesis
Must comply with Ministry of Public Health Announcement regarding Implanted Silicone Breast Prosthesis 2019 dated on November 7th, 2019
COVID-19 (SARS-CoV -2) diagnosis test kit
COVID-19 (SARS-CoV -2) diagnosis test kit means reagent, reagent product and kit component as well as calibrator or control material for both alone used or combination used for verification, confirmation or quantitative check in specimen from the human body to diagnose SARS-CoV -2 Examination approaches can be categorized into 3 methods as follows:
(1) Real time RT-PCR or others
Two usage of the kit are as follows:
(1) Test kits that must be used with the analyzer
(2) Test kits that do not need to be used with the analyzer
Remarks: Medical devices shall apply under medical device to be licensed classification must comply Attachment of this Announcement accordingly.