Shanghai, China – In February, Single-channel ECG Recorder of YuanXin Corp., a subsidiary of Shanghai MicroPort Medical Group Co., ("MicroPort®"), gained approval from Shanghai Food and Drug Administration ("SHFDA"). It is the first product approved according to the Registration Policy that was newly come into effect.
YuanXin Corp. is a wholly owned subsidiary established by Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP") in Shanghai Free Trade Pilot Zone. It primarily focuses on the technology development, technology service, technology consulting and technology transfer of medical technology and computer technology, the research and development of medical device and computer software, information service of medical device Internet, and the marketing of computer hardware/software, instruments and meters, and class I and class II medical device.
Single-channel ECG Recorder is composed of mobile recorders, host software, mobile application software and server front-end software. It is designed for medical institutions to collect, record and send ECG signals for patients. Single-channel ECG Recorder is designed in patch style, so patients can wear it for a long time with continuous acquisition of ECG signal. The ECG signals could be replayed with the software. The device could communicate with mobile APP, showing the real-time electrocardiogram, and it can provide immediate view and auxiliary diagnosis for physicians. Through the server front-end software, it can not only make the electrocardiogram display in real time, but also realize the sharing of ECG data. The launch of this device is expected to improve the efficiency of diagnosis and treatment for outpatients, and ease the burden for patients who need follow-up after discharge as well.
Currently, several domestic and overseas companies are developing devices similar to MicroPort® EP's Single-channel ECG Recorder, which means the first device to gain regulatory approval will enjoy first mover advantages. As a startup company focused on R&D, YuanXin Corp doesn't have manufacturing capabilities though it owns the technology. And according to the previous policies, its Single-channel ECG Recorder would by no means obtain approval so quickly. Thanks to the new Registration Policy, Shanghai Food and Drug Administration offered a special fast track procedure to the Single-channel ECG Recorder in which it checked the product and the company's production licenses at the same time, which shortened the approval time by 82% to merely 26 business days. Such innovative policy allows the Single-channel ECG Recorder to receive regulatory approval one year earlier than expected, and saved around one million yuan of productive investment for the company. It is reported that the Single-channel ECG Recorder is the only device of its kind with data management software and server front-end software that has gained the approval from SHFDA.
"The Registration Policy largely benefits companies as we can take advantage of the manufacturing site and equipment of our parent company for commissioned production, which largely save resources and enhance operation efficiency for the company," said Dr. Yiyong Sun, President of MicroPort® EP and Chairman of YuanXin Corp. "The company can throw the majority of resource and energy to R&D and innovation to increase product offering. At the same time, the policy allows start-up enterprises to improve production efficiency and reduce cost with the help of matured management system and advanced production capacity of peer companies. Meanwhile, according to the Registration Policy, the authorities will inspect the manufacturing system of the commissioned company and make both the commissioning and commissioned parties accountable for the product quality. "
The Registration Policy came into effect on December 7, 2017 by SHFDA. According to the policy, the enterprise registered in China (Shanghai) Pilot Free Trade Zone can commission other Shanghai-based medical device enterprises to produce its products, which means the manufacturing capacity is no longer a prerequisite for an enterprise to gain CFDA approval for its device. Such policy would largely shorten the approval procedure of medical devices, enabling patients to benefit from more innovative products.