Background IntroductionWith the continuous improvement of the living standards of the domestic people, their pursuit of beauty is unprecedentedly high. Based on market demand, a large number of household beauty devices have emerged, such as IPL hair removal devices, phototherapy products, radiofrequency beauty devices, Therma, etc. Based on the changing demand in this market, in order to reasonably control the risks of beauty devices, the Food and Drug Administration is gradually referring to the regulatory model of the US FDA and incorporating beauty devices as medical beauty devices into the scope of medical devices for management in batches.In March 2022, the bureau officially issued a notice requiring the inclusion of radiofrequency beauty devices in medical device supervision and their entry into the market under medical device licensing from April 1, 2024. 　　In April 2022, the bureau issued a notice soliciting opinions on the "Guiding Principles for Classification and Definition of Radiofrequency Beauty Products" (draft for comments). RF beauty devices are classified as follows:                  In July 2022, the bureau officially proposed classification and definition opinions for radiofrequency beauty products:　 Medical beauty is a new opportunity and trend in the development of medical devices. Based on this, Guangdong Province has issued relevant opinions on supporting the development of the medical beauty industry - the "Letter from the Office of the Guangdong Provincial Health Commission on Soliciting Opinions on Medical Beauty Surgery Projects and Their Graded Management Catalogue in Our Province" (hereinafter referred to as the "Draft for Soliciting Opinions").With China's economic growth and consumption upgrading, the medical beauty industry in China has developed rapidly, and its market size has jumped to second place. The industry has great development space and fierce market competition. The market size of China's medical beauty market has increased from 99.3 billion yuan in 2017 to 1891 billion yuan in 2021, with a compound annual growth rate of 17.5%. The growth rate of China's medical beauty market is much higher than the total market, and it is expected that the market size of China's medical beauty market will reach 226.7 billion yuan in 2022. Section 2: Strong AllianceRui Enni Consulting has been working in the medical device consulting industry for 9 years and has rich experience in domestic and international registration of medical devices. At present, there are 20 full-time consultants with complete project service capabilities (including design review for domestic and international markets, factory specifications, registration agency, system counseling, clinical trials, production licensing, education and training, and long-term consulting services).The customer registered for the NMPA radiofrequency skin therapy device was established in 2003 and is one of the earliest high-tech enterprises in China focused on the medical beauty industry. The enterprise has numerous high-quality talents with strong capabilities in design and development, quality management, and manufacturing, providing ODM and OEM services for top domestic and foreign brands.In the context of medical beauty enterprises, the client company has decided to register Class III radiofrequency skin therapy devices based on their own development needs. After multiple rounds of negotiations and discussions with various consulting firms, the client ultimately chose Rui Enni Consulting. This registration project is an important "iconic Class III medical device registration project" for Ruienni in the field of medical beauty devices. Ruienni is determined to make this RF project a golden model for enterprise services. It marks an important milestone in the development of Ruini in 2022; It also marks Ryan's active progress towards higher, faster, and more professional directions. This project has significant strategic importance for Rainey. At the beginning of the project kickoff meeting, the client's project representative delivered a warm speech. During the process, the customer representative explained the strategic significance of this registration project from the perspective of the enterprise itself, as well as the challenges and opportunities that the enterprise will soon face.Mr. Wang, the founder of Ruini, was also invited to deliver a speech. The project was summarized from various aspects such as the difficulty of product registration, registration plan, and project service team, and received warm applause from the client.At the end of the meeting, the founder of Ruini (left in the picture below) and the general manager of the client company (right in the picture below) signed the "NMPA Registration Agency Consulting Contract for RF Skin Treatment Equipment", and the project was officially launched. Section 3: OutlookAfter the project is signed, the next step will be for all members of the Ruini project team to participate in the service process. I believe that with mutual trust, sincere cooperation, and efforts from both parties, we can obtain the Class III product registration certificate and production license within the target plan.When we receive good news in the future, we will publish another article to report it to everyone!!!  

Mechanical root canal file is a dental rotary instrument that needs to be used in conjunction with a dental mobile phone to provide power. The machine used root canal file consists of a handle and a head working end. The body of the file is made of nickel titanium alloy, and the working end has grooves or spiral cutting edges. It is used for root canal preparation, auxiliary filling (i.e. cutting, leveling, cleaning, and shaping of dental bones, root canals, etc.) in dental treatment. The machine root canal file consists of an operating part and a rod, with a working part with a cutting edge on the operating part; The operating part is made of nickel titanium alloy material.Target users: The product must be used by dentists who have received formal training in root canal treatment. The expected usage location of this product is medical institutions, dental clinics, and similar occasions.Our company was commissioned by the client to handle the first registration of NMPA Class II medical devices for their company's machine root canal files at the end of December 2021. After 7 months, Rui Enni lived up to the customer's expectations and received the registration certificate approval on July 1, 2022. (Approval date: June 29, 2022, registration certificate number: Yue Xie Zhu Zhun 20222170852)After this registration, I have a few experiences to share with you:1) [Sensitive words] Step, first classify the root canal files according to their shape. The types of mechanical root canal files are complex, and according to their shape and taper, they can be classified into standard instruments, tapered instruments, molded instruments, non tapered instruments, and non single tapered instruments. The standard requirements corresponding to different classifications are also different.2) The second step is to carefully identify the type of root canal file within the applicable standards. Even for the same standard, each standard chapter should be carefully differentiated based on the different types of root canal files.3) Overall, from a professional perspective in the field of mechanical root canal filing, there are many shortcomings in the YY0803 sequence standard applicable to root canal filing. In terms of some content, most of the products that have already been launched do not actually meet some of the requirements of the YY0803 sequence standard. From the perspective of the reviewing teacher, mandatory requirements must be met. So, how to solve these contradictory problems is currently the challenge we are facing.4) There are many models and specifications of root canal files registered this time, with 56 registered models, and dozens of specifications are subdivided for different models. The product testing and issuance of test reports are also very patient tests. When testing at the provincial institute, the institute considers the model specifications to be large and is only willing to provide test reports for three main inspection models. All other models with differences in specifications need to be provided by the manufacturer themselves. Fortunately, due to policy changes, the drug regulatory authority can recognize the self testing reports of enterprises. This greatly saves product testing time.In summary, the NMPA registration of root canal files needs to focus on the compliance of standard terms and the consistency of similar compared products.

Rongfeng breast pump has obtained FDA 510K certification approvalK212884Electric breast pumps are classified as Class II medical devices in the United States Medical devices and products need to comply with the US FDA's regulations on medicine Requirements for medical equipment.The purpose of an electric breast pump is to allow lactating women to secrete and collect milk from their breasts. It is designed for individual users.The electric breast pump forms a sealed area around the nipple by sucking on accessories, and the air inside the sealed area is pumped away by the air pump, creating a vacuum and applying suction to the breast,Then release suction to stimulate lactation and extract milk. Milk is collected in the bottle.Due to the busy workload, more and more breastfeeding women choose to participate in work during their lactation period, and the use of electric breast pumps is safe Fully hygienic and convenient,Rongfeng has chosen to entrust us to handle the registration of their company's FDA 510K certification in the United States. Rui Enni fulfilled the client's commission and completed the approval of FDA 510K certification at the beginning of 2022.After this registration, there are several experiences that need to be shared, including:1) The breast pump is suitable for lactating women, single patient use, and needs to be cleaned and disinfected before use Poison;2) The testing of vacuum negative pressure needs to be ensured during operation;3) The instructions for using the breast pump need to comply with the requirements of the US Centers for Disease Control and Prevention.

Finger clip oximeters are a type of device in the United States Fang Medical Treat The main purpose of this device is to measure blood oxygen saturation (SpO2) and pulse through non-invasive methods at the fingertips.Due to the fine red color in the blood Cells, including oxygenated hemoglobin (HbO2) and reduced hemoglobin (Hb), are sensitive to red light (660nm) and red light Outside Line. (910nm) has different absorption abilities. Reduced hemoglobin (Hb) absorbs more red light Outside Line. Less. On the other hand, oxygenated hemoglobin (HbO2) absorbs less red light Outside Line. More. By setting the red LED and red at the same position on the nail oximeter Outside Line. LED lights, when light penetrates from one side of the finger to the other and is received by a photodiode, can generate a corresponding proportion of voltage. After being processed by the microcontroller, the output result is displayed on the LCD screen.During the epidemic, it was one of the five major components for epidemic prevention, along with masks, thermometers, oxygen concentrators, and ventilators. So during the epidemic, a large number of companies competed to register for certification of blood oxygen meters for export to Europe and America. After comparing with multiple peers, Lingxin Company was finally recognized by our experts Moved by business and sincerity, they chose to entrust us to handle their company's EU CE and US FDA 510K certification registration. Rui Enni fulfilled the client's commission and completed its CE certification before the first half of 2021, and obtained the FDA 510K certification approval by the end of 2021.After this registration, there are several experiences that can be shared, including:1) Confirm if the product claims to be suitable for children? If applicable to children, temporary Bed accuracy testing needs to consider appropriate samples; At the same time, consideration should be given to the duration of continuous use and prevention measures Stop the blood circulation caused by long-term pressure on the fingers Environmental issues;2) Confirm if the product is intended for low perfusion situations? If so, specific requirements of standards or guidelines should be considered for this;3) If the product has wireless functionality, the app settings and overall product planning need to meet the requirements of relevant countries Home network security Complete basic requirements;4) Suggestion for Lin Bed accuracy testing and consulting machine Structure Okay. Choose the same company to avoid arguing with each other; Lin Bed testing must meet the program requirements of GCP;5) When the product exceeds the effective range, an alarm prompt should be displayed, and values outside the effective range should not be displayed to avoid misunderstandings for users.6) Many companies' oximeters are purchased from solution providers, so it is important to confirm the maturity of the solution provider's products in the market. Many solution providers' designs have not undergone actual implementation Bed verification can lead to inaccurate measurements at the low oxygen level. At the same time, during the certification process, it is necessary for the solution provider to receive a quick response (such as when software or design modifications are needed) in order to ensure that the certification is passed quickly.  

The cervical spine treatment device has emerged in the past three years and is more suitable for white-collar workers. In recent years, brands with good operations have emerged continuously, such as SKG and Pangao. The promotion of cervical spine therapy equipment focuses on its stylish appearance, but performance is the key to obtaining a good after-sales reputation. The positioning of medical devices themselves is to have certain medical characteristics and uses, not just electronic products for gaming.Based on its strong pharmaceutical background, Miaobang Company is positioning itself and entering the cervical spine treatment device project, with the expectation of obtaining NMPA registration in China. The customer contacted our company through Baidu search, and after a face-to-face discussion, the customer decided to choose us. For me, I used to work in a company for 5 years producing physical rehabilitation medical devices, and our expertise lies in therapeutic equipment products. I still remember that in 2018, we achieved zero defect approval for two consecutive stimulators.During the application process, it took some time to rectify the inspection, so the important lesson here is that when companies enter the medical device industry, they must hire professional R&D and regulatory personnel with medical industry experience. The development of medical devices should be combined with standard design in design planning, rather than self-awareness or blind reference to marketed devices. This is the current situation in the industry. Many companies do not consider the need for verification and certification during development, and only realize that the design cannot meet the requirements during verification and certification. They repeatedly make design changes, which are time-consuming, expensive, and laborious.With the good cooperation of both parties in the later stage, we successfully passed the registration review and physical examination, and passed the NMPA registration. During the registration review, supplements were made due to issues with the product name. According to the new understanding of the National Medical Products Administration, medical devices should use a common name, so even if the cervical treatment device can only be used for neck treatment, it is still required to change to the common name of low-frequency treatment device. In the early market, similar products that had already been approved included: So the experience of this NMPA certification process is:1) Policies vary in different provinces; The scale of the same province is constantly changing and gradually becoming standardized;2) Priority should be given to selecting products from the same province within the past three years based on similar medical devices;3) Keep abreast of new regulations and policy trends in a timely manner, and maintain cognitive synchronization.

At the beginning of 2022, the results of the project were received - Taikang Medical Doppler Fetal Aspirator obtained FDA 510K certification approval with K number 211940.The client is a start-up medical device enterprise located in Pingshan. This project is an FDA 510K certification application submitted to the United States. The client attaches great importance to it, and after a round of comparison in the consulting circle in Shenzhen, they finally chose Rui Enni Consulting based on the recommendation of the testing laboratory and the promotion of high cost-effectiveness. At the beginning of the project, our consultant planned suitable inspection items for the client and assisted them in reviewing and providing relevant documents before the report was issued. Throughout the entire audit process, a round of supplements was made. In addition to the routine descriptive issues in the explanations, the auditors also made some audit findings and recommendations on the security report, performance report, and EMC report. At the same time, auditors pay special attention to the safety of batteries. In addition to testing reports, they also require a quality control plan for the battery production process. These issues are quite common for us, and we promptly analyzed and completed the rectification after receiving the audit findings. The FDA510K certification for the project was originally expected to be approved by the end of December 2021, but was postponed to early January 2022 due to the Double Dan Festival in the United States. Okay, let's start the new year with a beautiful outcome.