Import, manufacture or supply of personalised medical devices (including custom-made)

Personalised medical device

Personalised medical devices are devices intended for a particular individual, which could be a 1) custom-made, 2) patient-matched, or 3) medical device adapted from a mass-produced device.

1) Custom-made medical device

Import, manufacture or supply of custom-made medical devices

Custom-made medical devices do not need registration if they meet the criteria. Dealers need to update us on their list of custom-made devices.

Conditions for dealing in custom-made medical devices

You are allowed to supply custom-made medical devices without registering them if your device meets all of the following requirements:

• The device is made at the request of a qualified practitioner

• The device is made according to the specification as requested by the qualified practitioner, regarding the design characteristics or construction¹ of the medical device

• The device is intended for use on one individual only

• The device is not adapted from a mass-produced medical device

¹Design characteristics or construction is defined as:

Unique design specifications necessary to produce custom-made devices and which are based on an individual's specific anatomo-physiological features and/or pathological condition.

The qualified practitioner will undertake responsibility for the unique design characteristics requested, even though the design may be developed in consultation with a manufacturer.

Note:

• A custom-made medical device is intended for a case where an individual’s specific needs cannot be met or cannot be met at the appropriate level of performance, by an alternative device available on the market.

• Medical devices that are patient-matched, or mass-produced shall not be considered to be custom-made.

For dealers

You must have a valid dealer's license to import, manufacture and supply custom-made medical devices to the requesting qualified practitioner or HCSA licensed healthcare facility:

• If you are importing and supplying a custom-made medical device, you will need an importer’s licence and a wholesaler’s licence respectively.

• A manufacturer will need a manufacturer's licence.

• You are not allowed to supply unregistered custom-made medical devices to consumers (i.e. retail supply) directly.

Obligations

• All importers and manufacturers of custom-made medical devices must e-mail us a list of custom-made medical devices before its supply.

• Additionally, dealers must keep records of the requesting qualified practitioner's prescription or equivalent as evidence that the device was custom-made based on the qualified practitioner's request and specifications for his patient. These records may be requested from us for verification purposes.

• It is the duty of the manufacturer to ensure and maintain objective evidence to establish that the medical devices comply with the Essential Principles for Safety and Performance of Medical Devices. Please refer to GN-16: Guidance on Essential Principles for Safety and Performance of Medical Devices available at our website here.

2) Patient-matched medical devices

Patient-matched medical devices are described as follows:

• A medical device manufactured within a specified design envelope² and typically produced in a batch³ through a process that is capable of being validated and reproduced

• The device is matched to a specific patient’s anatomy within the design envelope

²Design envelope: refers to various parameters including minimum and maximum dimensions/size (e.g. length, breadth, thickness, angle), mechanical performance limits etc. relevant to a medical device.

Note: Design/specifications of the patient-matched medical device must remain within the validated parameters of the specified design envelope.

³Batch: one or more components or finished devices that are produced using the same lot of raw material, the same method of manufacture, having the same probability of chemical or microbial contamination, and that are intended to have uniform characteristics and quality within specified limits.

Import, manufacture or supply of patient-matched medical devices

Unlike custom-made medical devices, product registration is required for Class B, C and D patient-matched medical devices (MDs). Class A patient-matched medical devices do not require product registration, however the device dealers (manufacturer and/or importer) are required to submit a declaration of the list of Class A medical devices that they deal in under the importer’s and manufacturer’s licences, prior to import and supply in Singapore.

All medical device dealers will need to apply for a dealer's licence before you can import, manufacture and supply your devices in Singapore.

Please refer to our Quick Guide for an overview of medical device product registration and licensing.

Key differences between custom-made and patient-matched medical devices

Table 1:

Key difference*:

Custom-made device is so rare and unique that the manufacturer cannot reasonably validate the device’s design or its production process at the time it is requested.

Wherever possible, patients and qualified practitioner should access medical devices that are registered on SMDR and supported by appropriate objective evidence to the Essential Principles for Safety and Performance of Medical Devices.

The custom-made medical devices exemption addresses the different circumstances, such as rarity of the patient’s clinical presentation.

Note:

More information on patient-matched MD is found in the “Regulatory Guideline For 3D-Printed Medical Devices”.

The patient-matched MD definition and requirements in the Guideline is not limited to 3D-Printed MDs. Considerations from the abovementioned Regulatory Guideline that will also apply to non-3D printed patient-matched MDs include (i) specific information to be listed in the Annex 2 List of Configurations (Slides 22 & 31) and (ii) device labelling considerations (Slide 26).

3) Medical Device adapted from a mass-produced device

This refers to device which is mass-produced and is adapted, assembled or shaped prior use, to suit an individual’s specific anatomo-physiologic features.

It is subjected to the same level of regulatory control as a mass-produced medical device.

For HCSA licensed healthcare facilities

You can only produce medical devices in your licensed facilities without a Manufacturer's licence if the devices are intended for your own patients.

Note:

It is the duty of the manufacturer (i.e. Healthcare facilities producing the device) to ensure and maintain objective evidence to establish that the medical devices comply with the Essential Principles for Safety and Performance of Medical Devices.

GN-16: Guidance on Essential Principles for Safety and Performance of Medical Devices is available here.

Standards may be used to demonstrate conformity to the Essential Principles. Some examples of standards relevant to medical devices:

• Quality Management System: ISO 13485

• Material-related: ISO 10993

• Sterilisation-related: ISO 11137 (radiation sterilisation), ISO 17665 (steam sterilisation), ISO 11135 (ethylene oxide sterilisation) and ISO 10993-7 (residuals testing),

• List of Singapore Standards for Medical Devices

• Product standards: International Organization for Standardization (ISO)