Veterinary Medical Devices for Animals is a new niche going to develop quickly, considering that Thai culture is getting always more inclusive with pets.
Animals are becoming part of families, so they need prevention and treatments like humans.
WHAT IS THE DEFINITION OF MEDICAL DEVICE?
Under Thai law, the definition of a medical device is largely harmonized with international standards.
In general, devices that include software and accessories used for the diagnosis, monitoring, prevention, or treatment of diseases fall within the scope of a medical device, provided such devices do not achieve their primary intended action by immunological, metabolic, or pharmacological means.
It is worth noting that the Medical Device Act also governs medical devices used for animals.
Section 4 of the new Act describes a medical device as:
- An apparatus, appliance, implant, instrument, in vitro reagent, machine, product, software, or other article intended by the manufacturer to be used, alone or in combination or assembled with other things, for any of the following specific purposes:
- dental practice, healing arts practice, medical practice, medical technology practice, nursing and midwifery practice, physical therapy practice, and veterinary practice under the relevant specific laws or other medical or public health practices as notified by the Minister;
- alleviation, cure, diagnosis, monitoring, prevention, or treatment of human or animal disease;
- alleviation, cure, diagnosis, monitoring, or treatment of human or animal injury;
- investigation, modification, remedy, replacement, or support of the anatomy or of a physiological process of the human or animal body;
- supporting or sustaining life of human beings or animals;
- control of conception or promotion of human or animal fertility;
- aid or compensation for disabled or handicapped human beings or animals;
- providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human or animal body;
- disinfection or sterilization of a medical device
- Equipment or a component part of an instrument, apparatus, machine, object, or product under (1).
- Other apparatus, instruments, machines, objects, or products prescribed to be medical devices by the Minister. Any of the outcomes of a device’s function(s), as stipulated under (1), which occurs in a human or animal body, must not be derived from any immunological, metabolic, or pharmacological actions.
Are Veterinary Medical Devices for Animals under Thai FDA?
Yes, Veterinary Medical Devices for Animals are under the control of Thai FDA like normal Medical Devices. Their risk class might be reduced in case of same function dedicated to human or animals.
Does veterinary IVD for animals need Thai FDA approval?
IVD are considered as medical devices, despite their licensing process is slightly different. So, answer is yes, veterinary IVD for animals are subject to approval by Thai FDA. In Vitro Diagnostics for animal use are considered as risk class 1, the less controlled, requiring just a notification.
In case you want to import or register in Thailand veterinary medical devices or veterinary IVD, contact us at [email protected]
Telephone No.+66 02 1006351
