Act No. 29 of 2023
An Act to Regulate the Manufacture, Import, Export, Buying and Selling, Stocking, Storage, Display, Distribution and Quality Control of Drugs and Cosmetics Repealing the Drugs Act, 1940 And the Drugs (Control) Ordinance, 1982.
WHEREAS it is expedient to regulate the manufacture, import, export, sale, storage, display, distribution and quality of drugs and cosmetics and to prevent criminal activities in connection therewith: and
WHEREAS it is expedient and necessary to update Drugs Act, 1940 (Act No. XXIII of 1940) and Drugs (Control) Ordinance, 1982 (Ordinance No. VIII of 1982) and enact this new law.
Definition of Medical device:
“medical device” includes-
(a) all devices including an instrument, apparatus, implement, machine, appliance, implant, diagnostic reagent (in vitro, in vivo and in silico reagent), software or similar/related material or other article, whether used alone or in combination, to be used specially for human beings or animals by such means for one or more of the specific purposes of:
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) control of conception or disinfection of medical devices;
(vi) To provide information through examination and analysis of samples collected from human or animal body whose desired action is not affected by pharmacological, immunological and metabolic action.
(b) Any device and diagnostic reagent declared by the Government, by notification in the Official Gazette, for the purpose of carrying out the purposes of this Act.
For English translation:
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