Health Products Act |
Health Products (Medical Devices) (Amendment) Regulations 2018 |
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Citation and commencement |
1. These Regulations are the Health Products (Medical Devices) (Amendment) Regulations 2018 and come into operation on 1 June 2018. |
Amendment of regulation 2 |
2. Regulation 2 of the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010) (called in these Regulations the principal Regulations) is amended —
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New Part IA |
Deletion and substitution of regulation 3 |
4. Regulation 3 of the principal Regulations is deleted and the following regulation substituted therefor:
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New regulations 3B and 3C |
5. The principal Regulations are amended by inserting, immediately after regulation 3A, the following regulations:
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Deletion and substitution of regulation 4 |
6. Regulation 4 of the principal Regulations is deleted and the following regulation substituted therefor:
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Amendment of regulation 4B |
7. Regulation 4B of the principal Regulations is amended by deleting paragraph (b) and substituting the following paragraph:
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New regulation 4D |
8. The principal Regulations are amended by inserting, immediately before regulation 5 in Part III, the following regulation:
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Amendment of regulation 5A |
9. Regulation 5A of the principal Regulations is amended by deleting paragraph (b) and substituting the following paragraph:
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Amendment of regulation 5B |
10. Regulation 5B of the principal Regulations is amended —
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Deletion and substitution of regulations 6 and 7 |
11. Regulations 6 and 7 of the principal Regulations are deleted and the following regulations substituted therefor:
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Amendment of regulation 8 |
12. Regulation 8 of the principal Regulations is amended —
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Amendment of regulation 10 |
13. Regulation 10 of the principal Regulations is amended —
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Amendment of regulation 10A |
14. Regulation 10A of the principal Regulations is amended —
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Amendment of regulation 10B |
15. Regulation 10B of the principal Regulations is amended —
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Amendment of regulation 11 |
16. Regulation 11(1) of the principal Regulations is amended —
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New Division 2A of Part III |
17. Part III of the principal Regulations is amended by inserting, immediately after regulation 11, the following Division:
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Deletion and substitution of regulation 12 |
18. Regulation 12 of the principal Regulations is deleted and the following regulation substituted therefor:
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Amendment of regulation 13 |
19. Regulation 13 of the principal Regulations is amended —
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New regulation 13B |
20. The principal Regulations are amended by inserting, immediately after regulation 13A, the following regulation:
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Amendment of regulation 15 |
21. Regulation 15 of the principal Regulations is amended —
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Amendment of regulation 19 |
22. Regulation 19 of the principal Regulations is amended by deleting the words “such objective evidence” in paragraph (a)(ii) and substituting the words “where the medical device is a registered medical device, the objective evidence mentioned in sub‑paragraph (i)”. |
Deletion and substitution of regulation 21 |
23. Regulation 21 of the principal Regulations is deleted and the following regulation substituted therefor:
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Amendment of regulation 24 |
24. Regulation 24 of the principal Regulations is amended —
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Deletion and substitution of regulation 25 |
25. Regulation 25 of the principal Regulations is deleted and the following regulation substituted therefor:
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Amendment of regulation 26 |
26. Regulation 26 of the principal Regulations is amended —
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New regulation 27 |
27. The principal Regulations are amended by inserting, immediately after regulation 26, the following regulation:
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Amendment of regulation 31 |
28. Regulation 31 of the principal Regulations is amended by deleting paragraph (3) and substituting the following paragraphs:
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Deletion and substitution of regulations 33, 34 and 35 |
29. Regulations 33, 34 and 35 of the principal Regulations are deleted and the following regulations substituted therefor:
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Amendment of regulation 36 |
30. Regulation 36 of the principal Regulations is amended —
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Amendment of regulation 39 |
31. Regulation 39 of the principal Regulations is amended by deleting paragraph (1) and substituting the following paragraphs:
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Amendment of regulation 40 |
32. Regulation 40(1) of the principal Regulations is amended —
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Amendment of regulation 41 |
33. Regulation 41 of the principal Regulations is amended by deleting paragraph (1) and substituting the following paragraphs:
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Amendment of regulation 45 |
34. Regulation 45 of the principal Regulations is amended —
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Amendment of regulation 47 |
35. Regulation 47 of the principal Regulations is amended —
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Amendment of regulation 48 |
36. Regulation 48(2) of the principal Regulations is amended by inserting, immediately after the words “Fourth Schedule” in sub‑paragraph (d), the words “, if any”. |
Amendment of regulation 49 |
37. Regulation 49 of the principal Regulations is amended —
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Amendment of regulation 50 |
38. Regulation 50 of the principal Regulations is amended —
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New regulation 51A |
39. The principal Regulations are amended by inserting, immediately after regulation 51, the following regulation:
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Deletion of First Schedule |
40. The First Schedule to the principal Regulations is deleted. |
Amendment of Third Schedule |
41. Part II of the Third Schedule to the principal Regulations is deleted and the following Part substituted therefor:
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Amendment of Fifth Schedule |
42. The Fifth Schedule to the principal Regulations is amended by deleting items 4 and 5 and substituting the following items:
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Chairman, Health Sciences Authority, Singapore. |
[HSA/Legal/2018:17; AG/LEGIS/SL/122D/2015/3 Vol. 4] |
(To be presented to Parliament under section 72(5) of the Health Products Act). |