Singapore’s Health Sciences Authority (HSA) has enhanced its medical device regulations and improved the clarity of existing policies and requirements for telehealth devices and high risk medical devices. These changes went into effect on June 1.
The improvement of the city-state’s regulatory legislation is a part of HSA’s effort to encourage innovation and facilitate patients’ access to inventive medical technologies while continuing to protect their health and safety.
After consulting and engaging with leaders in the medical industry, here are the changes and clarifications HSA made:
- Class A sterile medical devices no longer need to be registered with HSA. To ensure safety and preserve post-market surveillance, importers and manufacturers must list their Class A devices on HSA’s public online Class A database.
- Class B registration route has been incorporated into the immediate registration route for devices that meet the following criteria:
- No safety issues associated with the device in any other market
- Approved by two independent regulatory agencies ORapproved by one agency accompanied by three years of marketing history in that market
- Class B and C stand-alone mobile medical applications that are approved by at least one regulatory agency without safety issues globally are now eligible for immediate market access.
- Telehealth devices intended for medical purposes are regulated as medical devices. Devices that are intended solely for well-being or lifestyle purposes are not subject to regulatory controls.
- High risk medical devices that are used for the modification of the appearance or the anatomy are subject to regulatory controls.
- Manufacturers are required to provide training for more complex medical devices that require users to have certain knowledge and skills to use them.
Additional regulatory information for Singapore: Singapore Medical Device Regulations
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