Pre-Market Controls

Question 1

How are products considered ‘unique’ & distinguishable from the other products

Answer 1

• product name
• product specification (ingredient, strength, dosage form)
• indications for use
• manufacturer?

Question 2

Controls on CPM under Medicines Act

Answer 2

• submission to HSA for assessment on safety and quality

- dealers can only deal with ‘listed’ CPM products even with the dealers license

Question 3

Classes of medical devices under HPA

Answer 3

Class A (lowest risk), B, C & D (highest risk)
- Class A exempted from product registration

Question 4

Classes of CTGT under HPA

Answer 4

Class 1 & 2

• by default, all CTGT are Class 2.
• CTGT can be assigned as Class 1 by HSA
• Class 1 can be conditionally exempted after notification to HSA and receiving HSA’s acceptance

Question 5

Controls on cosmetic products under HPA

Answer 5

• a very simplified pre-market ‘notification’ to HSA before starting to supply, however, no need to wait for HSA’s approval
• further notify HSA annually for as long as the company continues to supply the product