A key law for overseeing metal 3D printing in healthcare is the Announcement on the Release of the Supervisor and Administration Regulations for Customised Medical Devices (Trial), which was issued together by the National Medical Products Administration and the National Health Commission. Officially starting on January 1, 2020, this control will specify the criteria for the definition, filing, design, processing, usage, supervision, management of tailored medical devices. Customised medical devices are personalised medical tools created and produced by medical device makers in response to particular clinical needs of medical institutions, therefore addressing the unusual and unique lesions of specified patients. These gadgets are meant for specific patients in cases when items already on the market in China are challenging to fulfil clinical needs since they should improve diagnosis and treatment outcomes. Such tailored medical equipment is produced using 3D printing technology with metal, so rigorous compliance with this rule is absolutely required.
Customised medical equipment is only used for particular patients and has a very limited supply; hence, registering them using the present registration management system is challenging. With customised medical device makers and medical institutions jointly serving as record holders, the "Regulations" unequivocally mandate the establishment of record management for customised medical devices. The registrant shall file with the drug supervision and administration department of the province, autonomous region, or municipality directly under the central government where the medical device manufacturing enterprise is located-where the agent is located for imported products-before manufacturing and using customised medical devices. This filing system seeks to enhance the control over tailored medical equipment, thereby guaranteeing their safety and efficiency.
The regulation has proposed specific guidelines for manufacturing companies and medical facilities producing and using customised medical devices in order to fairly control hazards. Customised medical devices will not be commissioned for manufacturing; the registrant will satisfy the relevant requirements instead. The filing will automatically become invalid if customised medical device manufacturing companies do not have valid registration certificates or production licenses for medical devices made in large quantities that meet the same standard specifications or are made with similar main materials, technical principles, structure, key performance indicators, and approved use. The registrant is to actively cancel the filing. Regarding utilisation, an annual reporting system is set in place for the manufacturing and use of tailored medical devices; corresponding requirements have also been proposed for the use, advertising, and patient information protection of tailored medical devices. The pertinent manufacturing companies shall apply for registration or handle filing in line with the terms of "Medical Device Registration Management Measures" and "In Vitro Diagnostic Reagent Registration Management Measures" when the number of clinical use cases and preliminary research on customised medical devices can satisfy the pre-market approval requirements. Clinical evaluation materials for registration and application can include authentic, accurate, comprehensive, traceable clinical use data compliant with ethical norms.
Medical-grade pure tantalum, medical-grade nickel-titanium alloys, and metal 3D printing medical equipment mostly rely on metal materials, like titanium and titanium alloys. These materials must satisfy applicable national guidelines, including YY/T 0966-2014 "Surgical Implant Metal Materials Pure Tantalum", GB/T 13810-2007 "Titanium and Titanium Alloy Processing Materials for Surgical Implants", etc. The basis for guaranteeing the quality of printed goods is material quality; hence, their performance and purity are critical. The characterisation of metal powders should be done using elements including roundness, sphericity, flowability, tap density, and bulk density; their physical and chemical characteristics should be confirmed to satisfy the needs of medical device manufacture. Manufacturers must also describe and prove the quality of the mixed powders, check how the printing environment affects them, demonstrate that the process is stable and acceptable for medical use, and evaluate how recycling old powders might impact the printing process and results. In these cases, manufacturers use recycled old powders. Otherwise, we prohibit the use of recycled powder products.
Metal 3D-printed medical equipment must perform according to pertinent criteria. Regarding mechanical performance, it should be on par with conventional products, including bonding strength, shear strength, shear fatigue, compressive strength, tensile strength, wear resistance, four-point bending fatigue, rotational fatigue, etc. Analysing the porous structure-like the internal spaces, size of the holes, amount of holes, thickness of connecting ribs, average coating thickness, the area where the porous and solid parts meet, and surface roughness-is very important for products with porous structures. Additionally, the product must meet criteria related to surface roughness, microcracks, internal examination, and other factors concerning biocompatibility.
Among the crucial evaluation criteria for metal 3D printed medical equipment is biocompatibility. We should thoroughly test additive manufacturing medical devices in accordance with GB/T 16886. Material identification and chemical performance analysis are needed for particular goods, such as polylactic acid 3D-printed vascular stents. This includes variations in material composition before and after moulding and the study of solvent residue in the moulded products. Simultaneously, one should assess the product's performance in terms of size, mechanical characteristics, axial shrinkage rate, radial shrinkage rate, flexibility, product performance stability, etc. It is important to create and test the right lab methods to scientifically check how well the product breaks down. Regarding drug coating characteristics, a thorough assessment of the coating and its degradation performance is required.
Apart from the aforesaid criteria, there exist certain more pertinent guidelines applicable to metal 3D printed medical equipment. For example, when it comes to sterilisation and cleaning, one must adhere to the relevant guidelines. Product sterilisation by irradiation requires the specification of the irradiation dosage and accompanying verifying documentation. The GB 18280 series standards provide the particular dosage-determining foundation. To confirm the results of sterilisation and control the process for products sterilised with ethylene oxide, you need reports that follow the GB 18279 series standards for details. Refer to the GB 18278 series standards for specifics regarding products that have undergone moist heat sterilisation; sterilisation process parameters and validation reports should be provided. Describe the suggested sterilising technique precisely and provide a foundation for decision-making for non-sterilised packaged finished items. One should consult WS310.2-2016 "Hospital Disinfection Supply Centre Part 2: Technical Operation Specifications for Cleaning, Disinfection and Sterilisation". If one chooses to apply other sterilising techniques, they should provide a rationale for the approach, process confirmation, and a process control report.
Tight control and set criteria help guarantee the quality and safety of metal 3D- printed medical equipment. Strict management of raw materials, manufacturing techniques, product performance, and other factors helps lower the hazards associated with medical devices and minimise negative consequences for patients. For example, checking if medical devices are safe for human tissues helps reduce the chances of the body rejecting them; ensuring the quality of metal powders can stop implants from failing or causing bad reactions due to material issues.
Clear rules and regulations offer standards and direction for the expansion of metal 3D printing in the medical sector. By means of these criteria, companies can engage in production and product research to raise the competitiveness and quality of their products. Concurrent with this, better control and standards help draw more expertise and money into the industry, therefore encouraging industrial upgrading and technical innovation. For instance, as pertinent standards are constantly being introduced, more and more businesses are funding the research and development of metal 3D-printed medical devices, accelerating the growth of the sector.
Standard and legal guidelines together support global cooperation and communication. Various countries and regions have different regulatory and standard criteria for medical devices in the worldwide market, which presents specific challenges for the export and international collaboration of businesses. China's metal 3D-printed medical products can more readily access the global market by following international standards, thereby promoting sophisticated foreign technology and management experience as well as raising the general state of China's medical sector.
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