Singapore Blog Posts

Singapore’s HSA Implements Major Medical Device Regulatory Changes

EMERGO SUMMARY OF KEY POINTS:

  • The Singaporean HSA has begun enforcing new regulatory changes for medical devices starting June 1, 2018.
  • The changes affect lower-risk devices, digital health technologies and high-risk devices such as implantable products.
  • HSA also plans to improve domestic and overseas post-market surveillance activities.
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Singapore HSA Clarifies Telehealth and Mobile Medical App Guidelines

EMERGO SUMMARY OF KEY POINTS:

  • The Singapore Health Sciences Authority (HSA) has issued new clarification and an FAQ regarding how telehealth products and mobile medical apps are regulated in the country.
  • HSA plans an immediate market access pathway for mobile medical apps that have already registered in the US, Canada, Australia, Europe and/or Japan.
  • Singapore’s general regulatory approach to telehealth resembles that of the US FDA.
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Singapore HSA Establishes Priority Review for Qualifying Medical Devices

EMERGO SUMMARY OF KEY POINTS

  • Singapore’s Health Sciences Authority (HSA) has launched a priority review scheme for qualifying medium- to high-risk medical devices.
  • The new registration route provides faster Singapore market access for devices that address key HSA healthcare areas; are novel; or that target unmet clinical needs.
  • Class A devices as well as some combination products do not qualify for the new registration route.
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Singapore HSA Adjust Medical Device Field Safety Notice (FSN) Requirements

EMERGO SUMMARY OF KEY POINTS:

  • Singaporean hospital directors and managers must now be copied on field safety notices (FSNs) sent from medical device registrants.
  • The new FSN requirement came into force in early March 2017.
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Singapore Medical Device Regulators Target Telehealth

EMERGO SUMMARY OF KEY POINTS:

  • Singapore’s Health Sciences Authority (HSA) is proposing a clearer approach to regulating mobile medical apps and telehealth products as medical devices.
  • Only telehealth products whose intended uses are medical in nature would fall under full HSA regulatory requirements.
  • Telehealth products intended for general well-being use will not be regulated as devices, but will have to meet certain HSA labeling requirements.
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Singapore HSA Fine-tuning Good Distribution Practice for Medical Devices

Singapore’s medical device market regulator, the Health Sciences Authority (HSA), is planning a new good distribution practice standard for medical devices that requires licensure of companies importing and supplying devices in the country.

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Whatever Happened to the ASEAN Medical Device Directive?

Back in 2012 and 2013, Emergo and other medical device industry news sources began reporting on an effort by the Association of Southeast Asian Nations (ASEAN) trade bloc to establish harmonized device registration systems across 10 countries in the region.

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Singapore HSA Simplifies Import Declaration Rules for Medical Devices

The Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to change its import declaration requirements for medical devices and other healthcare products starting May 3, 2016.

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Singapore HSA Revises Medical Device Change Notification System

The Health Sciences Authority (HSA), Singapore’s medical device market regulator, is introducing revisions to its change notification system for medical devices effective December 1, 2015.

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New Medical Device Classification Tool from Singapore HSA

The Health Sciences Authority, Singapore’s medical device market regulator, has published a new risk classification tool for medical devices and IVDs.

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