Home 3d Printing Singapore: Health Sciences Authority publishes draft regulatory guidelines for 3D-printed medical devices

Singapore: Health Sciences Authority publishes draft regulatory guidelines for 3D-printed medical devices

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In brief

On 25 January 2021, the Health Sciences Authority (HSA) released a set of draft guidelines setting out the regulatory approach and regulatory requirements for 3D-printed medical devices (“Draft 3D-MD Guidelines”). It will also be carrying out a public consultation on the Draft 3D-MD Guidelines until 28 February 2021.


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The medical device landscape has faced rapid expansion in recent years, with the development of telehealth products and software medical devices that cater to the everyday healthcare needs of consumers at large. 3D-printing technology has contributed to this expansion, by enabling the manufacturing of patient-specific devices such as prosthetics or medical devices with complex internal structures.

The Draft 3D-MD Guidelines therefore represent a key first step towards clarifying the HSA’s risk-based approach vis-a-vis 3D-printed medical device regulation and its associated regulatory controls. In the shorter term, companies would do well to pay special attention to the HSA’s categorisation of 3D-printed medical devices, and to use the public consultation as an opportunity to seek clarification on aspects of the Draft 3D-MD Guidelines that they are unsure of. More generally, given that 3D-printing technology has applications in the pharmaceuticals and medicines space as well, companies may also wish to keep their eyes peeled for potential new draft guidelines that the HSA may subsequently release.

In more detail 

On 25 January 2021, the Health Sciences Authority (HSA) released a set of draft guidelines setting out the regulatory approach and regulatory requirements for 3D-printed medical devices (“Draft 3D-MD Guidelines”). It will also be carrying out a public consultation on the Draft 3D-MD Guidelines until 28 February 2021.

Under the Draft 3D-MD Guidelines, 3D-printed medical devices will be categorised as either a “mass-produced medical device” or a “custom-made medical device”. To qualify as a custom-made medical device, a medical device must fulfill three criteria:

  1. It is made at the request of a qualified practitioner and in accordance with the specifications of the qualified practitioner regarding the medical device’s design characteristics or construction. Here, “design characteristics or construction” refers to the unique design specifications necessary to produce custom-made devices, based on an individual’s specific anatomo-physiological features and/or pathological condition.
  2. It is intended to be used only in relation to a particular individual.
  3. It is not adapted from a mass-produced medical device.

Against the above definition, “patient-matched medical devices,” i.e., medical devices that are manufactured within a specified design envelope and typically produced in a batch through a verifiable and reproducible manufacturing process but are matched to a patient’s specific autonomy, would be considered “mass-produced” medical devices.

The categorisation of 3D-printed medical devices, in turn, impacts the degree of regulatory control that they will be subject to, as set out in the table below.

The Draft 3D-MD Guidelines will apply to all medical devices manufactured by 3D printing (except for in-vitro diagnostic medical devices) and include a table of basic considerations for 3D-printed medical devices to assist manufacturers and product owners. It should be noted that 3D-printed medical devices will continue to be subject to the current regulatory framework set out by the HSA. Namely, 3D-printed medical devices will continue to be subject to risk classification according to the HSA’s Guidance on Risk Classification of General Medical Device and change notification procedures under the HSA’s Guidance on Change Notification for Registered Medical Devices.

The Draft 3D-MD Guidelines, along with the public consultation feedback form, can be found here.



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