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.

Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018.

The Singaporean Health Sciences Authority’s (HSA) Health Products (Medical Devices) Regulations have been devised to allow faster market access for lower-risk devices and mobile medical applications, as well as to clarify regulatory requirements for some digital and high-risk devices.

Key components of the HSA reforms are examined below.

Faster market access for lower-risk devices

One aim of the HSA’s regulatory changes is faster Singaporean market access for lower-risk devices. To that end, Class A sterile devices will no longer be required to register with the HSA prior to commercialization in the country. (Manufacturers of Class A sterile devices will still have to list their products in the regulator’s Class A database, however.)

Furthermore, Class B devices that currently qualify for the HSA's expedited registration route will move to the immediate registration route if they meet criteria including:

• The device has no reported safety issues in other markets;
• The device has received approval by at least two other market regulators;
• The device has received approval by at least one regulator has at least three years of marketing history.

HSA anticipates that three quarters of all Class B applications will qualify for immediate registration based on these criteria.

In addition, Class B and C standalone mobile medical apps that have already been approved by at least one reference market regulator (Health Canada, Japan PMDA, US Food and Drug Administration, Australian TGA or European Notified Body) and no reported safety issues will also qualify for immediate Singaporean registration.

Regulatory clarifications

HSA has also included clarifications to existing regulations for digital health and higher-risk devices in this latest update:

• Digital and telehealth devices intended for medical purposes will fall under medical device regulation, whereas telehealth products intended for health or lifestyle uses will not fall under medical device regulatory oversight;
• High-risk medical devices used for cosmetic or anatomical changes—implants, injectable membrane fillers and invasive devices for fat removal or degradation—will fall under HSA oversight;
• HSA will require manufacturers of complex devices such as some implantable products to provide training to device users such as physicians and other healthcare providers.

Post-market efforts increasing

Under the medical device regulatory changes, HSA also plans to boost post-market surveillance efforts both domestically and by closer monitoring of alerts and safety issues in foreign markets.

Additional Singapore medical device regulatory resources from Emergo:

• Singapore HSA medical device registration and approval consulting
• Singapore Registrant in-country representation
• Medical device classification consulting in Singapore