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Health Products (Medical Devices) Regulations 2010
- https://sso.agc.gov.sg/SL/HPA2007-S436-2010
- 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 …
HSA | Regulatory overview of medical devices
- https://www.hsa.gov.sg/medical-devices/regulatory-overview
- We require companies to obtain a dealer's licence before manufacturing, importing or supplying medical devices. All medical devices will require registration with us before …
Health Products (Medical Devices) (Amendment No. 2) …
- https://sso.agc.gov.sg/SL-Supp/S950-2022/Published/20221209?DocDate=20221209
- These Regulations are the Health Products (Medical Devices) (Amendment No. 2) Regulations 2022 and come into operation on 9 January 2023. …
HSA | Medical devices
- https://www.hsa.gov.sg/medical-devices
- Medical devices are health products which have a physical or mechanical effect when used on human bodies. These devices are used to: Diagnose, alleviate or treat a medical …
HSA | Health products regulation
- https://www.hsa.gov.sg/about-us/health-products-regulation/
- Product Regulations. Medical devices; Therapeutic products; Health supplements; Traditional medicines; Chinese proprietary medicines; Cosmetic products; …
HSA | Guidance documents for medical devices
- https://www.hsa.gov.sg/medical-devices/guidance-documents
- Medical Devices Product Classification. Medical Devices Product Classification Guide 2148 KB; Product Specific Regulatory guidelines. Telehealth …
Health Products (Medical Devices) Regulations 2010
- https://sso.agc.gov.sg/SL/HPA2007-S436-2010?ProvIds=P1III-
- (2) To avoid doubt, as from the time that the Authority has allowed the supply mentioned in paragraph (1)(b), the medical device ceases to be a medical device whose planned use …
Health Products (Therapeutic Products) Regulations …
- https://sso.agc.gov.sg/SL/HPA2007-S329-2016
- Regulations 2016 In exercise of the powers conferred by sections 71 and 72 of the Health Products Act, the Health Sciences Authority, with the approval of the Minister for Health, …
HSA | Digital Health
- https://www.hsa.gov.sg/medical-devices/digital-health
- Identifying Digital Health Products that are Medical Devices As a general rule, a digital health device intended for medical purposes such as investigation, detection, …
MEDICAL DEVICE GUIDANCE - Health Sciences …
- https://www.hsa.gov.sg/docs/default-source/medical-devices/gn-13-r2-1-guidance-on-the-risk-classification-of-general-medical-devices-(18sep-pub).pdf
- Definitions that do not indicate they are set out in the Act and Health Products (Medical Devices) Regulations 2010 (Regulations) are intended as guidance in this document. …
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