新加坡医疗器械注册法规singapore-health-products-medical-devices-regulations-2010.pdf

HEALTH PRODUCTS (MEDICAL DEVICES) REGULATIONS 2010 Requested version was 01 Sep 2010; Closest available version is 10 Aug 2010; Generated on 01 Sep 2010 14:18:13(GMT+8). Front Page [ Jump to: Front Page / Arrangement of Provisions / Actual Provisions ] S 436 HEALTH PRODUCTS ACT (CHAPTER 122D) HEALTH PRODUCTS (MEDICAL DEVICES) REGULATIONS 2010 In exercise of the powers conferred by sections 45, 71 and 72 of the Health Products Act, the Health Sciences Authority, with the approval of the Minister for Health, hereby makes the following Regulations: Arrangement of Provisions [ Jump to: Front Page / Arrangement of Provisions / Actual Provisions] PART I PRELIMINARY 1 Citation and commencement 2 Definitions PART II MANUFACTURE AND IMPORT OF MEDICAL DEVICES WITHOUT LICENCE 3 Custom-made medical devices 4 Manufacture of medical devices by way of secondary assembly PART III SUPPLY OF MEDICAL DEVICES DIVISION 1 — WHOLESALE SUPPLY 5 Wholesaling of self-manufactured medical devices DIVISION 2 — UNREGISTERED MEDICAL DEVICES 6 Exception for custom-made medical devices 7 Exception for refurbished medical devices 8 Exception for medical devices for patients’ use 9 Exception for export or re-export 10 Exception for non-clinical use 11 Exceptions for phased implementation of prohibition DIVISION 3 — REQUIREMENTS FOR SUPPLY 12 Testing of registered medical devices before supply 13 Supply of “professional use only” medical devices PART IV PRESENTATION OF MEDICAL DEVICES 14 Trade descriptions 15 Information to be pro