Product Approval - Registration Requirements

Question 1

Which treaty is signed amongst ASEAN member states to harmonise the controls on cosmetic products, in order to facilitate trade for cosmetic products within the region?

Answer 1

ASEAN Cosmetic Directive

Question 2

Notification system for cosmetic products is provided in regulation___ of the ______Regulations

Answer 2

4; Health Products (Cosmetic Products – ASEAN Cosmetic Directive)

Question 3

Intent of Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations

Answer 3

to enable HSA to have a database of cosmetic products to facilitate post-market regulatory actions such as product recalls.

Question 4

Which class of medical devices are required to be registered?

Answer 4

Classes B, C and D medical devices are required to be registered

Question 5

Class A - D medical device: which is the highest risk?

Answer 5

Class D

Question 6

Full registration route: working days

Answer 6

270

Question 7

Abridged registration route: working days

Answer 7

180

Question 8

Verification registration route: working days

Answer 8

60

Question 9

Which product is eligible for verification route

Answer 9

Approval by 2 reference agencies

Question 10

Types of registration routes for CTGTP

Answer 10

Full, abridged routes