On 26/05/2013,
you requested for the version in force on 26/05/2013
incorporating all amendments published on or before 26/05/2013.
The closest version currently available is that of 10/08/2010.
FIRST SCHEDULE
Categories and Descriptions of Health Products to Which Act Applies
First column | Second column | Third column |
Category | Description | Exceptions and limitations |
1. Medical device | “Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of — | |
(a) diagnosis, prevention, monitoring, treatment or alleviation of any disease; | ||
(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; | ||
(c) investigation, replacement, modification, or support of the anatomy or of a physiological process; | ||
(d) supporting or sustaining life; | ||
(e) control of conception; | ||
(f) disinfection of medical devices; or | ||
(g) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, | ||
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. | ||
2. Cosmetic products | “Cosmetic product” means any substance or preparation that is intended by its manufacturer to be placed in contact with the various external parts of the human body or with the teeth or the mucous membranes of the oral cavity, with a view exclusively or mainly to — | |
(a) cleaning them; | ||
(b) perfuming them; | ||
(c) changing their appearance; | ||
(d) correcting body odours; | ||
(e) protecting them; or | ||
(f) keeping them in good condition. |
[S 564/2007; S 684/2007]