The FDA has the authority, by virtue of the Medical Device Act, to
order the advertisement to be amended, to prohibit the use of certain
statements or matters which appear in the advertisement, or to order
the cessation of the advertisement in the event that the FDA deems
that the advertisement is in violation of the requirements under the
Medical Device Act.
However, in practice, the FDA may have specific requirements for the
advertisement of certain types of medical devices which may not be
outlined under the Medical Device Act.
Finally, the Medical Device Act contains interesting provisions
relating to product liability. It provides protection to consumers
harmed by unsafe medical devices by stipulating that manufacturers,
importers, or sellers of medical devices are responsible for damages
incurred from their use, unless they can prove that the damage was
caused by force majeure or the injured person’s own fault, rather than
defects in the medical device. However, consumers may wish to claim
damages under the Product Liability Act, as it offers more protection
and possibility for recourse.
10.2.4 The Cosmetics Act
All cosmetics under the Cosmetics Act, B.E. 2535 (1992) (the
“Cosmetics Act”) are now considered to be controlled cosmetics. This
means that the labels for all cosmetic products must now meet the
requirements of the Cosmetics Act, namely;