Singapore legislation
Regulation 60
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 60
Saving and transitional provisions
Subregulation 1
From 1 March 2021 —
any registered Class D medical device that consists of a human cell or tissue is deemed a Class 1 CTGT product (called in this paragraph a deemed CTGT product);
a manufacturer of a deemed CTGT product who, immediately before that date, holds a valid manufacturer’s licence for a medical device issued under regulation 2A of the MD Regulations, is deemed a known manufacturer in relation to that product as if a notice has been given under regulation 4;
an importer of a deemed CTGT product who, immediately before that date, holds a valid importer’s licence for a medical device issued under regulation 2B of the MD Regulations, is deemed a known importer in relation to that product as if a notice has been given under regulation 7; and
a wholesaler of a deemed CTGT product who, immediately before that date, holds a valid wholesaler’s licence for a medical device issued under regulation 4D of the MD Regulations, is deemed a known wholesaler in relation to that product as if a notice has been given under regulation 10.
Subregulation 2
In this regulation —
Definition
“MD Regulations” means the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010);
Definition
“registered Class D medical device” means a medical device that is registered and assigned to Class D under regulation 24 of the MD Regulations.