新加坡医疗器械注册准入法规清单

韬略医服

[color=rgba(0, 0, 0, 0.9)]新加坡医疗器械的监管机构是新加坡卫生科学局(Health Sciences Authority, HSA)。HSA属于新加坡卫生部(Ministry of Health (MOH) Singapore) ，是负责监管西药、医疗器械、辅助健康产品、化妆品等产品的新加坡法定机构。HSA享用行政执法权，也拥有一般科研机构或事业单位的独立权和灵活性。

[color=rgba(0, 0, 0, 0.9)]医疗器械市场准入，法规先行。韬略医服建立了全球各主要市场的法规库。今天分享一下新加坡的医疗器械市场准入法规清单。

01 Health Products Act 2007

02 Health Products (Medical Devices) Regulations 2010

03 GN-15-R9 guidance on medical device product registration

04 GN-36-R2 guidance on medical device udi system

05 GN-34-R1.3 guidance document for ivd analysers

06 medical devices product classification guide

07 gn-17-r2 guidance on preparation of a product registration submission for gmd using the asean csdt

08 gn-18-r2-guidance-on-preparation-of-a-product-registration-submission-for-ivd-md-using-the-asean-csdt

09 gn-13-r2-1-guidance-on-the-risk-classification-of-general-medical-devices

10 gn-14-r3-guidance-on-the-risk-classification-of-in-vitro-diagnostic-md

11 gn-12-1-r2-1-guidance-on-grouping-of-medical-devices-for-product-registration---general-grouping-criteria

12 gn-12-2-r2-guidance-on-grouping-specific

13 gn-23-r2-guidance-on-labelling-for-medical-devices

14 gn-20-r2-guidance-on-clinical-evaluation

15 gn-11-r1-3_guidance-on-the-declaration-of-conformity

16 gn-16-r3-guidance-on-essential-principles-for-safety-and-performance-of-medical-devices

17 tr-01-r2-contents-of-a-product-registration-submission-for-gmd-using-the-asean-csdt

18 tr-02-r2-contents-of-a-product-registration-submission-for-in-vitro-diagnostic-medical-devices-using-the-asean-csdt

19 gn-02-r5-guidance-on-licensing-of-manufacturers-importers-and-wholesalers-of-md

20 gn-03-r3-guidance-on-preparation-of-a-site-master-file-for-licensing

21 gn-22-r7-4-guidance-for-dealers-on-class-a-medical-devices

22 gn-33-r1-2-guidance-on-the-application-of-singapore-standard-gdpmds

23 gn-06-r3-guidance-on-distribution-records

24 gn-21-r5-guidance-on-change-notification-for-registered-md

25 change-notifications-arising-from-the-eu-mdrivdr-related-changes

26 gn-24-r1-4-guidance-on-the-change-of-registrant

27 gn-25-r1_guidance-on-the-cancellation-of-medical-device-listing

28 gn-35-r4-guidance-on-special-access-routes

29 gn-08-r2-guidance-on-medical-device-advertisements-and-sales-promotion

30 gn-05-r2-1-guidance-on-the-reporting-of-adverse-events

31 gn-10-r3-6-guidance-on-medical-device-field-safety-corrective-action

32 gn-04-r2-2_guidance-on-medical-device-recall

33 gn-07-r2-2-guidance-on-complaint-handling

34 gn-09-r3-6-guidance-on-the-component-elements-of-a-dhcpl

35 gl-08-r1-regulatory-guidelines-for-laboratory-developed-tests-(ldts)

36 regulatory-guidelines-for-software-medical-devices---a-life-cycle-approach_r2

37 guidelines-risk-classification-samd-cdss

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