Regulations make the world go ’round…especially when it comes to 3D printed medical devices. The US FDA released draft guidance in May 2016, seeking feedback and continuing to explore the technology. In December 2017, the FDA issued its guidance on medical 3D printed devices, a move with implications on business operations and one pointing to a growing focus on additive manufacturing for the agency. Looking outside the US, other parts of the world have their own regulations and guidance when it comes to medical 3D printing as the technology continues to be adopted around the globe.
Over in Asia, the China Food and Drug Administration (CFDA) formally approved the manufacture and use of 3D printed hip implants, specifically those manufactured with metal 3D printing technologies, back in 2015.
This month, the Chinese regulatory agency’s Center for Medical Device Evaluation (CMDE) announced that it had issued new draft guidance regarding regulatory requirements for the complex sector of 3D printed medical devices.
The newly published guidance by the agency’s medical device market regulators, titled “Guidelines for the Technical Review of Custom Additive Manufacturing Medical Device Registration,” is meant to answer industry questions in regards to how the CFDA will go about approaching the regulation, and registration requirements, of important 3D printed medical devices on the Chinese market.
In a translated quote, the introduction to the new guidance states, “This guidance is intended to encourage the development of innovative medical devices, be customized additive manufacturing for the applicant (or simply ‘3D Print’) Medical Devices the registration application to provide technical guidance, as well as food and drug administration departments to provide technical reference for the review of registration dossiers.”
In addition to addressing industry questions, this guidance also proposes some specific requirements for the testing and validation of any 3D printed medical device products that are submitted to the CFDA for approval.
This new guidance covers 3D printed medical device implants for dental and orthopedic applications, along with 3D printed biomaterials and pharmaceuticals.
“This guidance does not cover all the requirements of medical devices specially designed a pharmaceutical composition comprising, cells, tissues and other biologically active substances in biological 3D printing, but can refer to the specific requirements of the applicable requirements,” the translated draft guidance states.
There are a variety of important regulatory proposals set out in the new CFDA guidance, such as requiring validation testing for all 3D printing equipment, materials, processes, software, and final products. It also states that product validations should include anti-pull strength and fatigue tests, usability tests, functionality testing and evaluation, and any components related to these.
The CFDA guidance proposes that clinicians and healthcare professionals should be involved in the decision-making for both the design input and output for 3D printed medical devices, and that environmental parameters for 3D printing must be defined in order to include energy density, gas composition, humidity, pressure, 3D printing speed, temperature, and other related factors.
Additionally, the guidance states that additive manufacturers should be required to conduct cleaning processes for complex 3D printed medical devices themselves, and not outsource them to other companies. The effectiveness of the chosen cleaning method must also be demonstrated.
“For products sterilized by irradiation, irradiation dose required to clear and relevant validation report,” the translated guidance says.
There is also a section on the use of animal models for testing 3D printed medical implants. Finally, the CFDA’s new draft guidance says that the use of 3D printed medical implants needs to involve contracts between the manufacturer, the healthcare provider, and the patient.
Right now, the CFDA is looking for comments from the industry in regards to its new guidance.
The CMDE says, “In order to make the Guiding Principles more scientific, reasonable, and practical, we will publicly solicit opinions on our website from now on. We sincerely hope that experts, scholars, managers, and practitioners in relevant fields can provide constructive suggestions or suggestions and promote guidance. The enrichment and improvement of principles will promote the quality and efficiency of registration declarations and technical reviews.”
Once all stakeholder comments have been received and compiled, the CFDA will issue a final version of its guidance.
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