Notice From The General Office Of The General Administration On Issues Related To Technical Requirements For Medical Device Products

Notice from the General Office of the General Administration on issues related to technical requirements for medical device products

Product technical requirements and legal status are clear

According to the "Regulations on the Supervision and Administration of Medical Devices", product technical requirements have been upgraded to statutory documents. Product technical requirements must be submitted when filing Class I medical devices and Class II and III medical devices. Manufacturers must organize production strictly in accordance with the registered or filed technical requirements to ensure that factory products meet mandatory standards. This shows that the entire chain from design to manufacturing has a clear legal basis, and illegal production will face severe penalties.

For CNC processing companies in the medical industry, it is extremely important to understand the legal status of product technical requirements. This is because it directly determines whether your processing technology and inspection standards comply with laws and regulations. Any deviation may be judged as illegal behavior.

Registration applicant preparation requirements

Applicants for medical device registration must prepare product technical requirements based on finished product performance indicators and inspection methods. Specifically, when applying for registration, it is necessary to submit complete product technical requirements and other application materials, which cover the composition of key parameters such as material hardness, dimensional tolerance, surface finish, etc. Each item must have clear quantitative standards.

In the medical industry, in CNC machining operations, this means that you must communicate with customers in advance to understand all process parameters. For example, if you are processing an implant for orthopedics, the dimensional tolerance may be accurate to the micron level. Such situations need to be recorded in the product technical requirements and used as the basis for subsequent production inspections.

Inspection agency pre-evaluation process

Medical device inspection agencies that accept registration inspections are required to carry out registration inspections for products according to the CNC processing requirements of the medical industry in accordance with product technical requirements. At the same time, according to the requirements of Food and Drug Administration [2014] No. 192, the inspection agency must also conduct a pre-evaluation of the product technical requirements submitted by the applicant, and the focus of this pre-evaluation is the rationality and testability of technical indicators.

For companies engaged in CNC machining, this means that the process parameters you have must have characteristics that can be repeatedly tested. Take the surface roughness Ra value as an example. You must not just write the word "smooth", but you must state the specific value and the method used for testing. Otherwise, the inspection agency is likely to judge it as unqualified.

Technical Review Organization System Evaluation

When reviewing a medical device registration application, the medical device technical review agency will conduct a systematic evaluation of the safety and effectiveness of the product based on the product technical requirements and other application materials. It will evaluate whether your design meets the CNC processing requirements of the medical industry , whether the process is stable, whether the inspection method is scientific, and finally give a conclusive review opinion.

In CNC machining in the medical industry, this means that the relevant materials such as processing process control files, inspection and test reports, etc. must be submitted together. Just like the General Administration Office's notice on issues related to the technical requirements for medical device products regarding the angle of the cutting edge of a surgical instrument, you must prove in the test report that its cutting performance meets clinical requirements, otherwise it may be returned by the review agency.

Enterprise factory inspection and recall system

Product-related technical requirements cover performance indicators and inspection methods. However, it is up to the company itself to decide which items need to be inspected before leaving the factory. Enterprises must formulate product inspection procedures based on the characteristics of the product itself, the production process used, and many other factors to ensure that the quality when leaving the factory is up to standard. If it is found that a product does not meet the corresponding standards or technical requirements, production must be stopped immediately, relevant parties must be notified to stop use, and the recall process must be initiated.

A complete and sound factory inspection system must be established. For CNC processing companies, dimensional measurements and material composition testing must be carried out for each batch of medical parts processed. Once substandard products are detected, the cause must be traced and the sold goods must be recalled.

Supervision, Inspection and Qualification Certification

The food and drug regulatory authorities will strengthen the supervision and inspection of medical device manufacturers, focusing on whether production is organized in accordance with product technical requirements. The food and drug regulatory authorities will strengthen the supervision and inspection of medical device manufacturers. Which product technical requirements can be used as the basis for supervision and random inspections. At the same time, the General Administration is actively adjusting and promoting the qualification accreditation of medical device inspection agencies. The food and drug regulatory authorities will strengthen the supervision and inspection of medical device manufacturers, and certify according to inspection items and parameters, so as to meet the needs of registration inspection and supervision and inspection.

For CNC processing in the medical industry, this means that your production line is likely to undergo regular or irregular on-site inspections. For example, inspectors will check your equipment calibration records and raw material purchase vouchers. Making relevant preparations in advance can prevent production suspension due to qualification issues.

Finally, please answer a question, has your CNC processing factory created a complete set of inspection processes based on product technical requirements? You are welcome to share your experience in the comment area, like it and forward it so that more peers can see it.