Summary of Singapore Medical Device Regulation changes (HSA briefing on 28 February 2018)

At the latest HSA briefing held on 28 Feb 2018, it was announced that a revised regulation is targeted to be rolled out in June or July 2018.

With the revised regulation, here are the following changes:

For Changes in Regulatory Requirements for Class A Medical Device (MD) after the revised regulation is implemented

• All Class A MD (includes Sterile) are not required for registration.

• Only notification is required and dealers have to do it by listing them in Class A database, prior to import/supply

• For solely Class A MD dealers, only DoC to QMS is required. 3rd Party Audit and

• Certification is not required anymore. QMSCAD will be obsoleted too.

• The draft will be published for comment in March/April.

For Changes in Regulatory Requirements for Class B MD after the revised regulation is implemented

• There will be no EBR-1 and EBR-2, they will be lumped under Immediate Class B Evaluation Route (IBR).

• Requirement for IBR include:

• No safety issues globally and with 2 reference regulatory agencies approval

or

• No safety issues globally with 1 reference agency and 3 years marketing history.

For Standalone Mobile Medical Device Applications

• Both Class B and Class C of Standalone Mobile MD will qualify for Immediate Registration Route if the device is reviewed and approved by 1 reference regulatory agencies and no safety issues globally

For Devices for Wellness Purpose

• Telehealth Products that is not intended for medical purposes has to indicate "intended for wellness purpose"

For Devices for Aesthetic Purpose

• HSA is focusing their regulatory oversight on high risk devices under this category.

• High risk devices are those

• with known or reported serious adverse events globally

• pose comparable risks to other regulated medical devices (e.g. foreseeable hazards)

• List of high risk devices intended for aesthetics-related purposes only that will be regulated as medical devices

• Any implant for the modification or fixation of any body part (e.g breast implant, gluteal implant)

• Any injectable dermal or mucous membrane filler (e.g. soft tissue fillers, wrinkle fillers)

• Any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means. (e.g. liposuction devices)

• Devices intended for aesthetic-related purposes that also have medical claims are already regulated as medical devices.

• Hence the devices in the positive list are currently subject to MD regulatory controls.

• Where devices intended solely for aesthetics-related purpose are not within the high risk list of devices to be regulated as medical devices (cryolipolysis equipment, laser devices for skin tightening)

• Some of these devices will still be subject to other local regulatory controls (e.g. NEA controls) Where applicable

• No impediment to market access

• Operational details on any follow-up actions required from dealers will be communicated at a later date.

For Trained User Only (TUO) MD

• This category will be introduced due to a Medical Device Reporting (MDR) that happened in the United States of America where deaths were reported. The device involved was meant to be used by non-doctors.

• The manufacturers will have to indicate the intended user and determine if training is required for the user to become a "trained user".

• Unlike Professional Use Only Devices, TUO will not have additional registration condition.

For Change Notification

• An updated guidance which include industry feedback from the previous focus group session will be published for public consultation.

Contact us at info@arqon.com.

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