Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device 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 (Notified 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 notified classification includes:
Non In-Vitro diagnostic medical device (Class A)
- 1) All non-invasive medical devices which come into contact with injured skin. If they are intended to be used as a mechanical barrier, for compression or for absorption of exudates only.
- 2) All non-invasive medical devices intended for channelling or storing body liquids or tissue, liquids or gases and for the purpose of eventual infusion, administration or introduction into the body.
- 3) All non-invasive medical devices not intended to be
a. Used principally with wounds which have breached the dermis, including medical devices principally intended to manage the microenvironment of a wound.
b. Used principally with wounds which have breached the dermis and can only heal by secondary intent.
c. For channelling or storing body liquids or tissue, liquids or gases and connected to medical device in class B or higher class.
d. Intended for use of channeling blood, or storing or channeling other body liquids, or for storing organs, parts of organs or body tissues and blood bags.
e. Intended for modifying the biological or chemical composition of blood or other liquids and intended for infusion into the body.
f. Intended for modifying the biological or chemical composition of blood or other liquids and the treatment consists of filtration, centrifuging, or exchanges of gas or of heat.
- 4) All invasive medical devices with respect to body orifices (other than those which are surgically invasive) intended for transient use and which are not intended for connection to an active medical device, or are intended for connection to a Class A medical device only.
- 5) All invasive medical devices with respect to body orifices (other than those which are surgically invasive) intended for short-term use and intended by its product owner for use on the external surface of any eyeball; or it is liable to be absorbed by the mucous membrane.
- 6) All surgically invasive medical devices intended for transient use and reusable surgical instruments.
- 7) Active medical devices intended for diagnosis and used solely to illuminate the patient's body, with light in the visible or near infrared spectrum.
- 8) Active medical devices not intended to be
a. All active therapeutic medical devices intended to administer or exchange energy including ionising radiation
b. All active medical devices intended to control or monitor the performance of active therapeutic medical devices in Class C, or intended directly to influence the performance of such medical devices.
c. Active medical devices intended for diagnosis and intended to supply energy which will be absorbed by the human body.
d. Active medical devices intended for diagnosis and intended to image in vivo distribution of radiopharmaceuticals.
e. Active medical devices intended for diagnosis and intended to allow direct diagnosis or monitoring of vital physiological processes.
f. Active medical devices intended for diagnosis and monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient.
g. Active medical devices intended for diagnosis and diagnosing in clinical situations where the patient is in immediate danger.
h. Active medical devices intended to emit ionising radiation and intended for diagnostic and/or interventional radiology, including medical devices which control or monitor such medical devices, or those which directly influence their performance.
i. All active medical devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body.
- 9) All medical devices manufactured from or incorporating non-viable animal tissues or their derivatives that come in contact with intact skin only and manufactured from or incorporating
- animal cells, tissues and/or derivatives thereof, rendered non-viable, or
- cells, tissues and/or derivatives of microbial or recombinant origin.
In-Vitro diagnostic medical device (Class A)
- 1) Reagents or other articles that possess specific characteristics, intended by the product owner to make them suitable for in-vitro diagnostic procedures related to a specific examination.
- 2) Instruments intended by the product owner specifically to be used for in-vitro diagnostic procedures.
- 3) Specimen receptacles.
The decree has been implemented starting from August 13, 2020 onwards.
Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Notified Registration 2020