May 9, 2018
HSA aims to strengthen Singapore’s Medical device regulatory guidelines to benefit both end users and industry. Last February, HSA held a briefing in order to present key proposal changes in the existing regulation. The said event focused on six proposed key changes to current regulations.
1.) Regulatory requirements for Class A and B medical devices
Regulatory requirements for Class A devices
Currently, Class A devices are classified as sterile or non-sterile wherein the former is needed to be registered. In the proposed change, all Class A devices, sterile or non-sterile, won’t be needed to be registered anymore. Instead, all Class A devices will be needed to be listed in a public online Class A database.
For registration of dealers who solely handle Class A devices, third- party certification is no longer required.
Regulatory requirements for Class B devices
Currently, Class B devices has four evaluation routes:
- Full Evaluation
- Abridged Evaluation
- Immediate Evaluation
- Expedited Evaluation
In the proposed change, Immediate and Expedited Evaluation will be replaced by Immediate Evaluation route (expanded scope). Devices that will be qualified for the new route will need 2 reference agency approvals or 1 reference agencies with 3 years marketing history
The mentioned changes in Class A and Class B requirements are in line with HSA’s aim to increase regulatory requirements as the risk classification of the device increases. In addition, HSA are continuing to balance pre-market and post-market regulatory controls to ensure patient safety. Some of this controls will include random compliance and monitoring scheme and putting up public online database (for Class A devices) for the public to improve traceability.
2.) Faster access to stand-alone mobile applications
A software and/or mobile application that is intended to function by itself and are not intended for use to control or affect the operation of other hardware medical devices is referred to as Standalone mobile application.
Mobile applications for Class B and C mobile medical device which have the following will be eligible to Immediate Class B and New Immediate Class C registration route respectively.
- At least one reference agency approval
- No safety issues globally
3.) Clarifying the scope of the medical device regulatory framework
This section involves Telehealth products which are involved in the provision of healthcare services over physically separate environments via infocom technologies. Telehealth products which is intended to be used for investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process will be subjected to regulatory control. Otherwise, such telehealth products are required to be labelled to clearly inform the users of the product’s appropriate use. This said label should be located in labelling material areas which are practicable (e.g. packaging, IFU).
An example of telehealth products that are not subjected to regulatory control are devices for wellness purposes. In order to prove the claim of wellness devices, a clarification statement from the manufacturer is needed.
Devices for modification of appearance or anatomy
Key clarifications have been made regarding devices that are used for modification of appearance or anatomy only. HSA will only control such devices that are considered high risk. HSA will regulate devices that have high risk that is included in the following list which can be expanded in the future as needed:
- any implant for the modification or fixation of any body part(e.g. breast implant, gluteal implant)
- any injectable dermal filler 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)
In addition, HSA mentioned the following to be applicable to devices intended solely for modification of appearance or anatomy which are not within the high risk list of devices to be regulated (e.g. 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
4.) Trained user only (TUO) and Professional user only (PUO) medical devices
Manufacturer’s intent of use for both TUO and PUO devices should be included in the IFU/user manual/Product Insert. This is applicable to all devices including unregistered devices via special authorization routes. HSA will only step in if the agency disagree with the manufacturer’s intent and may have additional requirements.
TUO medical devices will not have additional registration condition. The devices’ suppliers will have the responsibility to ensure that these will be supplied to appropriate users. In addition, the local registrants/ dealers of these type of medical devices should collaborate with the manufacturers/product owners to arrange a training program for the appropriate local users at the time of supply of the device.
5.) Changes to registered medical devices (Change notification)
Regulations will be updated to allow for certain specific non-significant changes to not require notification to HAS. Some of the guidelines that will corrected will be as follows:
- To update the description of the change notification categories to reflect the scope of the “Technical” “Review” “Administrative” and “Notification” change categories
- Technical changes (Class C and D) and Review Changes (Class B) –Changes that affect the safety, quality and efficacy of the registered medical devices
- Administrative change refers to a change that does not affect the safety, quality and efficacy of the registered medical device that involves change to any information entered on the SMDR in respect of that medical device except changes to delete or remove such information from SMDR.
- Notification change refers to any change other than administrative change that does not affect the safety, quality and efficacy of the registered medical device.
The updated guidance will be posted on HSA website once finalized.
6.) Requirements for Dealers’ licenses
The current pre-requisites in place for the medical device dealers’ licenses will be included within the regulations
- Manufacturer’s License –able to comply with the requirements of ISO 13485 in relation to the manufacture of the medical device
o ISO 13485 to be defined in the Regulations to cover both the current 2016 edition and the previous 2003 edition of the standard to enable compliance
- Importer’s and Wholesaler’s Licenses –able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices (GDPMDS) or ISO 13485
o GDPMDS standard for medical devices to be defined to include current TS-01 GDPMDS Requirements (before 9 November 2020) and the Singapore Standard for GDPMDS (SS 620)