The " Medical Device Supervision and Administration Regulations Amendment (Draft for Review)" promulgated by the Ministry of Justice recently stated that it fully implements the Medical Device Listing Permit Holder System (MAH), and provides for marketing approval for medical device production and medical device operation and use. The holder can produce or operate on his own or entrust other companies to produce and operate his products. Previously, the Shanghai Free Trade Zone took the lead in piloting MAH and expanded the system from Pudong to Shanghai on July 6, 2018.
The whole process of design, development, verification, registration, licensing, listing, production and sales of medical device products is very complicated and it is difficult to complete it by itself. MAH realizes the separation of registration certificate and production license, which is undoubtedly beneficial to the social division of labor. Especially for small and micro enterprises with research and development capabilities, on the one hand, production management and control capabilities are not formed overnight, on the other hand, medical equipment production investment is extremely difficult. The burden is even better.
Juyi Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Jiangxiang Technologyâ€) is one of the first few service companies to anticipate the separation trend of medical devices and actively deploy CRO and CMO services for medical devices in advance. Established at the end of 2014, Juyi Technology is committed to providing a full range of product development, registration and production services for small and medium-sized medical device companies, universities and medical clinics throughout the world, through the whole process of device innovation from product concept to market. Obtained ISO13485:2016 certification.
According to Cao Changqing, general manager of Juyi Technology, in the interview, the cooperation mode that Juyi Technology can provide includes product upgrade design, product quality cost optimization, new product cooperation development, and commissioned production plan. “We use a flexible cooperation model to quickly respond to and optimize product design processes and team design experience to help customers reduce time-to-market; quality, regulatory and product registration teams with extensive medical regulatory experience to effectively help customers reduce regulations and related Cost; use local supplier resources to provide competitive product costs, product design fully considers productivity, maintainability, and reduce total customer costs." Cao Changqing said.
It is reported that Juyi Technology has nearly 1000m2 advanced medical device R & D center and perfect product life cycle management process, and is equipped with multiple safety regulations, electromagnetic compatibility, reliability testing laboratory and sterility test, positive control, microbial limit, etc. GMP-required sterile laboratories are used to support R&D testing and validation activities.
On the team side, the platform has nearly 50 engineers of various types of product development, testing, production process development, supply chain management, quality and regulations. The main engineers have long served internationally renowned medical device companies, and have rich medical device research and development. Production management experience.
In addition, the company has built a 2,300 m2 high-quality CMO commissioned manufacturing base and passed the CFDA on-site system assessment, which includes a 100,000-class clean workshop in compliance with GMP standards, and an active equipment production test workshop. Juyi Technology has realized electronic two-way traceability in the whole process of production, inspection and delivery, and is in line with international business operation standards. It is one of the few professional medical equipment CMO manufacturing plants in China with this capability.
There are many types of medical devices, and how to design production lines to meet the diversified needs of enterprises, Cao Changqing said that Juyi Technology uses the concept of technology platform. “For example, there are many types of active devices, but the architecture of the technology is similar. We have built many technical platforms internally, and we match the products of our customers based on the technology platform. A large device and a few device control systems are similar. It's just that the sensors are different, the drive is different, but the core modules and concepts are the same. We design the module based on this way. The development of a product, the new technology only accounts for 20-30%, others It is a mature technology. For small enterprises, we can provide mature parts, and we can work together with new technologies. In this way, the entire research and development cycle will be shortened, and the risk of research and development will be reduced." Cao Changqing said.
In just a few years, Juyi Technology has accumulated more than 10 European and American and Chinese medical device customers in the research and development of CRO and CMO business, most of which are international and domestic famous listed companies or industry benchmark enterprises, becoming many A qualified R&D service provider of internationally renowned medical device companies in China. Through the giant R&D and CMO platform, multiple customers have realized the transformation of medical device products from concept to product. Under the premise of ensuring compliance, the company has reduced the investment and accelerated the pace of product launch.
At present, Juyi Technology has researched and researched nearly 20 types of products in category 2 and category 3, covering many product areas such as intelligent drug infusion, surgery, IVD, rehabilitation, medicine and machinery, etc. Invented patents and entered the innovation declaration channel. Several Class 2 and Class 3 devices have entered the clinical, registration or upcoming mass production phase.
Cao Changqing said that with the gradual implementation and cultivation of the MAH system, it is expected that the CRO+CMO of medical device research and development will form a potential market of tens of billions of yuan. According to the interview, Juyi Technology has obtained two rounds of strategic investment from leading domestic investment institutions to continue to expand the medical device R&D service team, CMO production service base scale and global market business expansion and continue to strengthen technology platform and system construction.
“Juli Technology will strive to become a leading domestic and influential CRO and CMO platform company for medical device research and development in the Asia-Pacific region. It will continue to cooperate with medical device companies to develop more medical device products and improve human life quality with innovative technology. Cao Changqing said.
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