The customer is a well-known manufacturer of blood pressure monitors, and this MDSAP certification includes five member countries. The products include electronic blood pressure monitors (arm and wrist). Throughout the entire coaching process, our company dispatched two system consultants for comprehensive guidance. During the coaching process, they patiently provided guidance on QMS systematization, regulatory conversion, design and development modules, and ultimately successfully obtained the MDSAP certificate.

The customer is an electronic blood pressure monitor and infrared thermometer manufacturer headquartered in Dongguan and with a factory located in Jiangxi. The Korean client of the client requested KFDA certification. Upon receiving the commission, our company immediately planned a practical and detailed system coaching plan, and dispatched two system consultants for coaching. With mutual trust and active cooperation from both parties, we successfully obtained the KGMP audit from South Korea and obtained the certificate smoothly. The entire coaching cycle is 3.5 months.

The client is a high-tech enterprise in Shenzhen and a well-known brand in the medical beauty industry. The enterprise adopts a commissioned production model, and during the MDSAP certification coaching, the certificate holder and two commissioned production enterprises participated in the scope of this certification.The product range includes IPL hair removal devices and radiofrequency skin therapy devices. The entire tutoring period is 3.5 months, and during the synchronization process, the KGMP system was also tutored. Through our company's reasonable system coaching plan, three system consultants were dispatched to provide on-site coaching, successfully completing the preparation and review within the expected period of the client, and obtaining the certificate smoothly.

The customer is a French company that mainly produces electrical stimulators, including TENS and EMS technologies.The rectification audit cycle lasted for a total of 3 rounds. Throughout the entire certification audit and issuance process, our company collaborated with enterprises to complete communication and rectification of issues related to clinical evaluation, product technical characteristics, etc. by auditors one by one, and finally successfully obtained the MDR certificate.The entire cycle takes about 18 months.  

Development history of hearing aidsHearing aids are important auditory aids that help people with hearing impairments reintegrate into society and enjoy wonderful sounds and rich environmental sounds. The origin of hearing aids can be traced back to the 17th century. After centuries of changes and innovations, hearing aids have evolved from mechanical devices to electronic devices and then to digital devices. Technological advancements have made hearing aids smaller and more in line with human needs, resulting in improved performance and a better user experience.Conventional hearing aids generally require a professional doctor to test the patient's hearing impairment, and then configure them professionally based on the test results to provide better hearing compensation to the patient. Until 2021, the United States approved self fitting hearing aids that can be sold and used directly to consumers without the assistance of hearing professionals, bringing about a significant change in the convenience and experience of hearing aid use. Users no longer need to go to the hospital or seek professional audiology experts. They can purchase a hearing aid and use the accompanying app to test their hearing loss and configure suitable hearing aids to compensate for hearing loss.※ Classification of hearing aids in the United StatesThe United States has divided hearing aids into 19 product codes and 9 regulation numbers, of which 7 codes require 510 (k) registration, while other hearing aids are exempt from 510 (k) registration. For a more detailed description of the types of hearing aids, please refer to our other article titled "Hearing Aids and Personal Sound Reinforcement Products: Notes"（ https://mp.weixin.qq.com/s/BMpr5vNnc6cVNoVHs_HFDA ）. With the advancement of technology and the emergence of self fitting hearing aids, in 2022, the US Food and Drug Administration added the product code "QUH" for over-the-counter self fitting hearing aids on the basis of the original product code "QDD", distinguishing prescription and over-the-counter self fitting hearing aids.※ Registration processIn this self fitting hearing aid application, we went through the transition of product code from "QDD" to "QUH". The process from submitting no clinical trials and usability validation to issuing additional clinical trials and usability validation. After receiving the FDA's request for clinical trials and usability, I started preparing the clinical trial and usability validation plan, and submitted Q-Sub to discuss the feasibility of the plan with the FDA. After unremitting efforts and communication, we finally determined the clinical trial and usability plan.The clinical trial was conducted by Ruieni Group's Zhuyitong Company in two hospitals within China; SMO was completed by Borussia of Ruini Group; The usability study was planned, statistically analyzed, and summarized by Ruini Consulting, and the 510 (k) registration process from submission to submission was completed by Ruini Consulting. Thanks to the active efforts of Ruini and the client, the submission of the supplementary documents was finally completed before the deadline for submission.It took more than 5 months from submission to certification, and finally completed registration at the end of September, becoming a Chinese [sensitive word] OTC self fitting hearing aid approved by the US FDA.Experience sharingAs the service provider in China who obtained this case, Ruini would like to share its experience in OTC self fitting hearing aid registration.1. Non prescription hearing aids can be used by non professionals, who can directly purchase, use, or operate them, thus requiring higher safety requirements than prescription hearing aids. Among them, the maximum output limit for loud sound should not exceed 117dB at any frequency; the material of the earplug must be undamaged and the depth of the sensitive word must be kept at least 10mm away from the eardrum.2. When measuring the electroacoustic performance of an acoustic coupler, a 2cm3 acoustic coupler should be selected. Only when the 2cm3 acoustic coupler is incompatible with the hearing aid, other scientifically effective and technically equivalent acoustic couplers should be considered, and the basic principles of using alternative acoustic couplers must be recorded.3. Usability verification should include all expected usage environments, characteristics of the user population, and the proportion of experienced personnel. The subjects should perform the test under adverse conditions and collect any usage error information or data such as decision-making errors, operational errors, interpretation errors, etc., and conduct a summary analysis to confirm whether these errors affect the safety and effectiveness of the product.4. The FDA may accept clinical trials conducted outside the United States, but it is necessary to ensure that the clinical data is sufficient, truthful, ethical, and scientifically effective. This clinical trial is a randomized, crossover, single blind, non inferiority multicenter clinical trial. The experiment is divided into two stages: laboratory stage and on-site cross wearing stage, and effectiveness (including primary and secondary indicators) and safety analysis are conducted for each stage. ※ ConclusionThe approval of 510K OTC self fitting hearing aids is a credit and honor that belongs to the customer, colleagues from Ruini Group, clinical researchers, and statistical experts. It is the result of the joint efforts of all personnel working together!!!

Intense Pulsed Light (IPL)Intense pulsed light (IPL) is a non laser light source composed of a single or multiple pulse sequence of incoherent light, characterized by a wide spectral range and high energy density. Short wavelength light can be filtered out using filters or coatings. For example, the 560 treatment head filter retains the spectrum within the wavelength range of 560nm to 1200nm, except for the band shorter than 560nm. The light source of the strong pulse light device is a xenon lamp, and its basic working principle is that a trigger applies high voltage to xenon gas to trigger xenon ionization. After being charged for a relatively long time through an energy storage capacitor, it discharges in a very short time, causing avalanche ionization of xenon gas inside the lamp tube. Xenon gas converts and releases the charged energy in the form of high-intensity light radiation, and this discharge process is a light pulse.Using strong pulsed light with a certain penetration depth and good absorption ability in melanin, the hair follicles and hair shafts irradiated by light absorb a large amount of light energy, which is converted into heat energy and transmitted to the end of the hair follicles through the protein inside the hair, causing the entire hair to be heated. The protein and cells undergo coagulative necrosis, ultimately leading to the loss of the entire hair due to the necrosis of growing cells.In the past, common hair removal methods in family environments included hair removal cream, wax paper, and hair scraper, which belonged to chemical or physical hair removal. 　　Hair removal wax paper uses brute force to remove hair, which not only causes strong pain, but also easily leads to folliculitis; The hair removal knife only removes the surface hair, so frequent scraping is needed to maintain it, and there is a risk of scratching; Hair removal cream belongs to chemical hair removal, which uses chemical substances to make hair fragile and prone to breakage, achieving the effect of hair removal. It is easy to cause skin allergies, has a short maintenance time, and has high long-term and large-scale use costs.At present, the common hair removal equipment in hospitals or beauty institutions is generally a large multifunctional strong pulse light therapy device with a foot pedal.   　　With the development of technology, IPL strong pulse light technology can be used in home environments and medical beauty institutions, and the equipment has become increasingly compact and portable through upgrades and iterations. 　　Recently, the strong pulse light therapy device assisted by Shenzhen Ruienni submitted an application according to the registrant system and was awarded one of the first batch of medical device registration certificates approved by the Guangdong Provincial Drug Administration for clinical evaluation (registration certificate number: Yuexizhun 20232090285).During the registration process, the evaluation center focused on some key points with strong professional skills, such as the cut-off wavelength of the filter, the number of pulses, and the method of energy adjustment.During the rectification process, a technical evaluation expert review meeting was held to address the differences in pulse energy and energy density between the proposed registered product and the comparison devices of the same variety. We have made sufficient preparations in advance before this meeting. During the meeting, we provided a comprehensive and detailed explanation and examples of the product's technical principles, structural materials, functions, safety and effectiveness related to clinical evaluation. The results of the meeting were unanimously recognized by the expert group.Ruini lives up to the customer's trust! Within just over a month of submitting supplementary materials after the expert review meeting, we successfully obtained the registration certificate for the "Intense Pulse Light Therapy Device" issued by the Guangdong Provincial Drug Administration for clinical evaluation approval.Here, we would like to share some points that need to be noted during the clinical evaluation and review process of selecting the same variety for NMPA registration:When selecting the same variety for comparative analysis and clinical evaluation, it is necessary to focus on the technical key points of implementing various functions of the product, such as the wavelength range of terminal output pulse light, pulse energy, and energy density.1. Wavelength range: In the wavelength range of most registered and marketed devices, the long wavelength can reach 1200nm, while some products have a long wavelength of only 950nm or even shorter, or longer than 1200nm. When submitting clinical evaluation terminals for comparative analysis of the same product, it is necessary to explain the safety and effectiveness of the product from both theoretical and clinical perspectives.2. Pulse energy: Excessive pulse energy can cause varying degrees of adverse events. In comparative analysis, if the pulse energy of the device to be declared is higher than that of the equipment compared with the same variety, it is necessary to explain in detail the method of controlling the use of energy in the product, as well as the numerical changes in pulse energy and energy density to ensure the safe use of the equipment.