By virtue of the definition of "licensor" in Article 4 of Medical Device Act 2018.The Secretary-General of the Food and Drug Administration has issued the announcement as follows:
1. Cancellation of Food and Drug Administration Announcement regarding Criteria for Full Evaluation and Concise Evaluation on 4, October 2018.
2. The following medical devices is applicable for full evaluation and concise evaluation:
a) Injectable Hyaluronic acid
b) Cleaning Products Containing Alcohol as a Component for Hygienic Use
c) Products Containing Alcohol for Humans, Animals Sterilization and Medical Device
d) Laser medical device
e) Automated External Defibrillator: AED
f) Screening test
3. Qualification for medical device that is applicable for concise evaluation is as follows:
a) Have received an approval or is registered and is marketed in 2 of 5 countries and is under complete authority of the countries as follows:
1) Australia (Therapeutic Goods Administrative: TGA)
2) Canada (Health Canada: HC)
3) European Union Notified Bodies: EU NB
4) Japan (Japan Ministry of Health, Labour and Welfare: MHLW)
5) United States (US Food and Drug Administrative: US FDA)
An approval or registered and marketing period of medical device must exceed a minimum of 1 year. Or have received an approval or is registered and is marketed in 1 of 5 countries and is under complete authority of the countries as mentioned above. An approval or registered and medical device must exceed a minimum of 1 year and is in WHO list of prequalified in vitro diagnostics products. If a medical device registration resulting from the Cooperation Agreement between the two countries (MOU), it is considered that a medical device is registered in only 1 country.
b) Medical device that is applicable for concise evaluation must have an identical information of intended use; indication; labelling; instruction for use and packaging as clause a).
This announcement is implemented from now onwards.
Translated from official ThaiFDA announcement, by
Food and Drug Administration Announcement regarding Criteria for Full Evaluation and Concise Evaluation