With some organisations considering the use of 3D printed medical devices to counteract the shortfall in availability of Personal Protection Equipment (PPE), accessories for respirators and other items such as nasopharyngeal swabs, the Health Sciences Authority (HSA) in Singapore has recently issued guidance specific to this situation.
The guidance on 3D printed medical devices covers regulatory controls, licensing, product registration and notification, post-market duties and obligations. The guidance also covers some key technical considerations for design, validation, labelling and expiration as well as manufacturing to ensure the quality, safety and effectiveness of medical devices created using 3D printing.
All medical devices created via 3D printing are likewise classified into four risk classes: Class A (lowest risk) to Class D (highest risk). Face shields and external prosthetics that are manufactured using 3D printing are typically classified as class A. Whereas ventilator tubes or breathing circuits would be classified as Class B. Medical devices that are implants will typically fall in Classes C and D.
All manufacturers or suppliers of 3D printed medical devices must hold the relevant dealer licence from the Health Sciences Authority. A Quality Management System (ISO 13485 or equivalent) must also be in place for the 3D printing of the medical device. However, this requirement is relaxed for healthcare institutions or facilities which create medical devices via 3D printing for use on their own patients as long as the medical device is not supplied outside of the said healthcare facility.
All 3D printed medical devices that are intended for commercialisation must be registered with the HSA before being placed on the market except for Class A. Class A medical devices created through 3D printingdo not require registration, however they do require notification to the HSA before being placed on the market.
More information on the Guidance can be found here. And if you have any queries regarding medical devices created using 3D printing for the Singapore market or our services for medical device registration and representation in Singapore, please contact us at email@example.com.