Steady increase for medical products related to the COVID – 19 pandemic has been a challenge not only for Singapore but for the rest of the world. This, in turn, results to the shortage in such products. That is why several organizations have seriously considered producing medical devices using 3D printing (3 – DP) to cope with the demands. HSA is actively responding to such propositions to expedite the situation and has placed several regulatory considerations concerning 3 – DP medical devices.

Risk Classification

Regulatory controls depend on the risk classification of medical devices, which are divided into four classes: Class A, B, C and D (A being the lowest risk and D being the highest risk class). Such classification will also apply to 3 – DP devices:

• Class A 3-DP: nasopharyngeal swab and face shield.
• Class B 3-DP: Breathing circuits and ventilator tubes
• Class C 3-DP :dental or orthopedic implants
• Class D 3-DP: Cranial implants and heart valves are

Dealer License for Establishments dealing with 3-DP

A relevant dealer’s license from the HSA must be in possession of an organization that wants to manufacture, import or wholesale 3 – DP medical devices. A Quality Management System (QMS) certificate (ISO 13485 or equivalent) is a strict requirement for manufacturers of such devices. However, for healthcare institutions that will not supply their 3 – DP medical devices outside of their facility will not be required to hold a license.

Registration of 3-DP

A basic requirement for the registration or notification of a 3 – DP medical device is that they must comply with the Essential Principles of Safety and Performance. Class B, C and D 3 – DP devices must be registered first before they can be supplied while Class A 3 – DP devices only require notification. Healthcare institutions manufacturing their own 3 – DP devices that will be used on their own patients will not be required for registration but still has to comply with the Essential Principles.

Real – world clinical use of 3 – DP medical device must also undergo close monitoring to identify possible new risks and limitations. Careful monitoring must also be done to ensure that the device continues to perform as intended and any adverse effect can be identified, like allergies induced by materials used for the device, susceptibility to infections and serious health deterioration when the device fails to perform. Reporting of adverse effects, defects and recalls are required to be conducted by manufacturers, importers, wholesalers, health professionals and users in order to implement necessary mitigation measure to correct such issues and prevent recurrence.

There are also key technical considerations for 3 – DP medical devices, such as:

1. Device design, which includes dimensional specifications, critical feature, material specifications, applicable material standards and methods, range of physical parameters if applicable, and compatibility and appropriate fit of accessories with the device itself
2. Device validation, which includes biocompatibility, performance, testing, sterilization, removal of material residues, and functional and usability.
3. Device labelling and expiration, where sufficient information must be included for identification and/or tracing and specific instructions for the save and effective use of the device,.
4. Device manufacturing, which includes the method, materials, flowchart, and proof of QMS/ISO 13485 certification. Novel design, features and other functionalities also require validation for safe use.

Production of 3D – P devices may temporarily alleviate the shortage issue of medical devices during this COVID -19 situation, but HSA priority is to ensure that these devices are safe, effective, and are of high quality.

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Reference:

Guidance on 3-D Printing of Essential Medical Devices and Accessories for Use in COVID-19 (Coronavirus Disease 2019) Situation