The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of medical devices and other healthcare products, has published a FAQ document dedicated to 3D-printed medical devices. The document provides additional clarifications on the applicable registration timelines, as well as the regulatory status of 3D printers and software used to manufacture medical devices, the raw materials used for 3D printing, applicable international standards, and other matters to be taken by medical device manufacturers and other parties involved.
The document expands the information provided in the respective guidance published earlier by the HSA and is intended to assist medical device manufacturers using 3D printing (additive manufacturing) technology to produce medical devices. The information is provided in the form of answers to the most frequently asked questions regarding the above-mentioned matters. It is important to mention that the clarifications and recommendations provided by the HSA are non-binding and should not be construed as legal advice of any kind, so the way the provisions of the respective legislation should be applied in a particular situation should be determined on a case-by-case basis.
First of all, the document addresses the matters related to the registration timelines. In this respect, the authority emphasizes that unlike custom-made medical devices, all Class B, C, and D patient-matched medical devices are required to be registered on Singapore Medical Device Register (SMDR). The general procedure of medical device registration in Singapore is described in detail in the respective guidance published by the HSA.
The authority additionally emphasizes that medical device manufacturers intended to supply their patient-matched medical devices in Singapore shall apply for registration of their products before August 1, 2022.
Regulatory Status of 3D-Printing Equipment and Software
Under the general rule, 3D printers and software used to operate them should be treated as manufacturing equipment. Hence, they would not be subject to regulation under the medical device framework. At the same time, concerning manufacturing activities, the parties involved should consider the provision of respective international standards describing the requirements for the Quality Management System (for instance, ISO 13485).
Regulatory Status of Raw Materials
The document further describes the regulatory status of raw materials used for 3D printing. According to the document, they should be treated in the same way as any other raw materials used to manufacture medical devices. Since the choice of raw materials would affect the safety and effectiveness of the final products, the appropriate controls should be implemented by the requirements set forth by the Quality Management System. The authority also mentions that some dental materials, however, may be approved for the specific intended use (i.e. material used to manufacture partial or full crowns and bridges) are regulated as a medical device, regardless of it being used in manufacturing by 3D printing or conventional methods. The material in its finished form should be tested for safety and performance for its proposed use.
Regulatory Status of 3D Printed Anatomical Models
The types of 3D printed products covered by the scope of the present FAQ include, inter alia, 3D printed anatomical models used for educational purposes, in the course of the consultation, or for surgery training. These products are not considered medical devices, hence, they are not subject to regulation under the respective framework.
Switching from Conventional to Additive Manufacturing
The guidance also describes the regulatory approach to changes in manufacturing methods. According to the guidance, in a situation when a medical device has been manufactured via conventional methods, and then a new model is manufactured by the virtue of additive manufacturing, a new model cannot be added to the same group of medical devices registered under the same entry due to the different manufacturing method used. Hence, a change notification procedure cannot be applied, and a new registration will be required. Moreover, as described by the HSA, different 3D printing methods such as Selective Laser Melting (SLM) and Electron Beam Melting (EBM) are considered as different manufacturing processes. Consequently, in the case of two medical devices manufactured with different additive manufacturing methods, two separate submissions will be required. Changes to the additive manufacturing method used should be treated in the same way as any other changes to the manufacturing process, and the general rules will be applicable.
Requirements for Patient-Matched and Custom-Made Medical Devices
The document provides additional clarifications regarding various regulatory matters associated with patient-matched and custom-made medical devices. For instance, the authority states that both patient-matched and non-patient-matched medical devices could be submitted for registration as a family, provided they meet the respective grouping criteria. These criteria include, inter alia, the “common manufacturing process”, and this criterion should be also fulfilled to ensure the eligibility of both devices for submission as a medical device family.
Under the general rule, custom-made medical devices are not subject to product registration. At the same time, the parties interested in placing them on the market are obliged to submit the appropriate notification to the regulating authority and provide information about the medical devices to be supplied. Moreover, these parties should also comply with the appropriate licensing requirements and fulfill the respective post-market obligations.
The authority additionally emphasizes that medical device manufacturers and other parties involved in the supply of custom-made medical devices are obliged to document and keep records of the underlying requests from healthcare practitioners describing the device needed and its functions. Apart from this, the general record keeping requirements, such as the obligations to keep the records of distribution and complaints are also applicable. The authority is entitled to request such records to verify compliance with the applicable regulatory requirements.
To assist medical device manufacturers and other parties involved in operations with 3D-printed medical devices, the present FAQ document also provides a list of applicable international standards addressing various aspects including, inter alia, terminology, test methods, design, as well as materials & processes. For instance, the standards describing the test methods are:
- F2971-13 Standard Practices for Reporting Data for Test Specimens Prepared by Additive Manufacturing;
- F3122-14 Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Process.
In summary, the present document provides additional clarifications regarding the regulatory framework for 3D printing technology in the context of manufacturing medical devices. The document highlights the most important aspects to be considered for registration requirements and change notification.
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