Health Products Medical Devices Regulations

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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 …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device …

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. Within the context of a robust …

Health products policy and standards - World Health …

https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations

The 67th WHA approved the resolution “Regulatory system strengthening for medical products." It states the importance of regulations for medical devices as one of the …

Code of Federal Regulations (CFR) | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr

Code of Federal Regulations (CFR) | FDA Code of Federal Regulations (CFR) FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is …

Health Products (Medical Devices) (Amendment No. 2) …

https://sso.agc.gov.sg/SL-Supp/S950-2022/Published/20221209?DocDate=20221209

1. These Regulations are the Health Products (Medical Devices) (Amendment No. 2) Regulations 2022 and come into operation on 9 January 2023. …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

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 …

Medical Device Regulation: Importance and …

https://apacmed.org/medical-device-regulation/

In Singapore, all medical devices are regulated by the Health Sciences Authority (HSA). Scope A dealer’s license is required for companies that seek to …

Factsheet: medical devices overview

https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview

Regulations on medical devices Medical devices in the UK are regulated by the Medical Devices Regulations 2002 (as amended) which provides for a system of medical …

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Health Products Medical Devices Regulations