Singapore Medical Device Regulations

At Manningham Medical Centre, you can find all the data about Singapore Medical Device Regulations. We have collected data about general practitioners, medical and surgical specialists, dental, pharmacy and more. Please see the links below for the information you need.

HSA | Regulatory overview of medical devices

https://www.hsa.gov.sg/medical-devices/regulatory-overview

All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from product registration, or under specific conditions as approved by us. Please refer to our Quick …

HSA | Medical devices

https://www.hsa.gov.sg/medical-devices

Before you continue: You are encouraged to check if your product is considered a medical device in Singapore.; You will need to determine your medical device’s risk …

Health Products (Medical Devices) Regulations 2010

https://sso.agc.gov.sg/SL/HPA2007-S436-2010

No. 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 …

How medical devices are regulated by HSA

https://www.hsa.gov.sg/consumer-safety/articles/how-medical-devices-are-regulated-by-hsa

How are medical devices regulated in Singapore? Product Registration - Medical devices must be registered with HSA to ensure they meet the regulatory requirements before …

Singapore Regulatory Approval Process for …

https://www.emergobyul.com/resources/singapore-regulatory-approval-process-medical-devices

The medical device approval process in Singapore explained. Step 1. Medical Devices in Singapore are governed by the Health Sciences Authority (HSA). …

Medical Device Registration and Approval …

https://www.emergobyul.com/services/medical-device-registration-and-approval-singapore

Medical device regulations and classification in Singapore. Medical devices in Singapore are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). …

Medical Device Regulation Singapore - CMS MedTech

https://cmsmedtech.com/medical-device-regulation-singapore/

Class B C D medical devices need to go through the formal registration process which consists of submission of technical documentations (in the form of CSDT) …

HSA | Adverse events reporting of medical devices

https://www.hsa.gov.sg/medical-devices/adverse-events

Any adverse event (AE), which meets the three basic reporting criteria listed below, is considered as a reportable adverse event: An AE (or potential AE) has occurred. The …