On March 5, 2025, Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary Viora Ltd. (hereinafter referred to as “Viora”) received the “Acceptance Notice” issued by the National Medical Products Administration (NMPA), and its application for registration of the Class III medical device optical radiofrequency therapy device V30 was accepted. It is reported that Viora, an energy source medical beauty device company, was acquired 100% of its equity by Sinclair, a wholly-owned subsidiary of Huadong Medicine in the UK, in February 2022. This time, the acceptance of Sinclair’s Xinkeli Aesthetics all-round skin medical beauty product V30 registration application is another major progress in the field of medical beauty energy source equipment. Huadong Medicine continues to expand its minimally invasive + non-invasive medical beauty map, realizes the layout of the entire industry chain on a global scale, continuously enhances its comprehensive strength in the medical beauty sector, and gradually advances to the ...
Drugdu.com expert’s response: Products exported to the European Union (EU) require CE certification primarily for the following reasons: I. Compliance with EU Regulations CE certification is a product certification system implemented by the EU to protect the safety of humans, animals, and plants, serving as a passport for manufacturers to access and enter the European market. According to EU regulations, only products with CE certification can freely circulate in the EU market and be considered to meet the basic requirements of EU directives. Therefore, CE certification is a mandatory threshold for products seeking to enter the EU market. II. Ensuring Product Safety The core purpose of CE certification is to ensure that products comply with relevant safety standards, providing consumers with reliable and consistent protection. By obtaining CE certification, products must meet a series of safety requirements aimed at preventing potential risks of personal injury and property damage during use. ...
The reporter learned from Mindray Biotech that Mindray Biotech and Likang Biomedical Technology Holdings Co., Ltd. recently officially signed a strategic cooperation agreement. This strategic cooperation focuses on blood gas products and focuses on the field of critical and emergency diseases for adults and neonates. It is the advantage of Wuhan Mindray and Likang Biotech in forming strategic synergy and resource complementarity in three aspects: expert guidance, benchmark demonstration and market expansion. Innovate instant diagnosis and lead smart medical care. https://finance.eastmoney.com/a/202503043335621969.html
During the 2025 National People’s Congress, Zhao Jing, deputy to the National People’s Congress and vice chairman of Buchang Pharmaceutical (603858), made suggestions on “AI empowering the inheritance and innovation of traditional Chinese medicine” and proposed solutions for the modernization of traditional Chinese medicine from the aspects of policy planning, technology integration, and industrial upgrading. Zhao Jing suggested that by establishing a standard system for traditional Chinese medicine data to standardize traditional Chinese medicine terminology, promote cross-domain data sharing, formulate a strategy for the integration of AI and traditional Chinese medicine, and clarify demonstration projects for application scenarios such as intelligent diagnosis and telemedicine. In the field of intelligent manufacturing, she proposed the use of AI technology to transform production links, including precise control of temperature and humidity, screening of Chinese herbal medicine ingredients, and the construction of a full-process quality traceability system. She suggested that the government should issue ...
Jiang Lingfeng, deputy to the National People’s Congress and vice chairman and president of Zhifei Bio, submitted several suggestions on the biomedicine industry at this National People’s Congress. Among them, in order to “promote the high-quality development of the biomedicine industry in the Chengdu-Chongqing Twin Cities Economic Circle”, Jiang Lingfeng suggested optimizing the review and approval mechanism of biomedicine in Chengdu and Chongqing, increasing policy support, and at the same time, providing more support in talent cultivation and introduction, and innovation resource allocation. In order to “further promote the collection of non-immunization program vaccines and promote the healthy and sustainable development of the vaccine industry”, Jiang Lingfeng suggested resolving historical arrears through special debts, optimizing the disease control payment system, and building a new “special fund direct payment” mechanism to effectively alleviate the financial pressure of enterprises. https://finance.eastmoney.com/a/202503053337321863.html
In recent years, the development of the biopharmaceutical industry has been in full swing. Policy support, capital influx and technological innovation have formed a synergy to promote the industry into a period of rapid growth. Ankang, deputy to the National People’s Congress and chairman of Hualan Bio, an important domestic leader in the field of blood products, vaccines and monoclonal antibodies, proposed during the two sessions of the National People’s Congress that it is recommended to optimize the construction of the centralized procurement system for biopharmaceuticals and support the high-quality development of biopharmaceutical companies. Recently, An Kang, deputy to the National People’s Congress and chairman of Hualan Bio, said in an interview with Cailianshe reporters: “General Secretary Xi Jinping attended the private enterprise symposium and delivered an important speech, emphasizing that the development prospects of the private economy in the new era and new journey are broad and promising, and ...
Drugdu.com expert’s response: Pharmaceutical data collection plays a broad and far-reaching role, encompassing the entire lifecycle of the pharmaceutical industry, from research and development to sales. Here are the specific roles of pharmaceutical data collection: Supporting Market Analysis: Pharmaceutical data collection aids companies in analyzing market prospects, understanding industry trends and competitive landscapes, and provides data support for strategic planning. By comparing competitors’ products, companies can identify their strengths and weaknesses, thereby formulating more effective market competition strategies. Assisting in Product R&D: In the pipeline and planning stages, pharmaceutical data collection relies on mature data resources to analyze potential drug candidates through multiple dimensions such as clinical needs, competitive landscape, and market capacity, providing a scientific basis for product R&D. The data collected can also be used to assess the R&D prospects and market potential of drugs, helping companies optimize the allocation of R&D resources. Ensuring Drug Quality and Safety: Pharmaceutical data collection ...
On March 4th, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the clinical trial (IND) application for freeze-dried respiratory syncytial virus mRNA vaccine submitted by Aibo Biotechnology (acceptance numbers: CXSL2400848, CXSL2400849, CXSL2400850) has been granted clinical implied permission. This is the first product of Aibo Biotechnology to be approved for clinical use using proprietary base modification technology, which is of milestone significance. Respiratory syncytial virus (RSV) is the most common viral pathogen causing acute lower respiratory tract infections, after influenza virus. It is commonly found in susceptible populations such as the elderly and infants, and causes a large number of complications and deaths every year, resulting in a huge economic burden. As of now, only three RSV vaccines have been approved globally, and there are no related products on the market in China, resulting in huge clinical demand. The ...
Recently, STAAR Surgical (NASDAQ stock code: STAA), A leading manufacturer specializing in the production of implantable lenses for vision correction, due to the sluggish Chinese market, announced that it will lay off a total of 115 employees at its two factories in California on April 21st. 01. The sharp deterioration of demand in China has led to layoffs However, STAAR Surgical has made it clear that this layoff will not result in the closure of any factories and will still retain over 550 employees in Southern California. Behind this layoff is the business pressure caused by weak demand in the Chinese market. A spokesperson for STAAR Surgical explained in an email, “This decision is made to put our company in the best position amidst the current weakness in our largest end market and ongoing macroeconomic and geopolitical challenges putting pressure on our business. From a data perspective, STAAR Surgical’s business ...
According to the China Medical Device Innovation and Priority Approval Database, one innovative medical device has entered the special review process in a public announcement released by local drug regulatory authorities across the country: the fetal magnetocardiography of Mandi Medical Instruments (Shanghai) Co., Ltd. (hereinafter referred to as Mandi Medical). Fill the domestic gap Mandi Medical was founded in 2009 and is an innovative enterprise specializing in the research and development, production, and sales of biomagnetic medical imaging equipment. It is committed to becoming a global leader in China’s biomagnetic diagnostic solutions. Moreover, Mandy Medical is currently the first domestic enterprise to obtain the Shanghai CFDA medical device registration certificate for cardiac magnetic examination equipment. It has a series of core bio magnetic technologies, strong capital strength, and a first-class talent team. The magnetocardiogram (MCG) is a functional examination device that uses highly sensitive magnetic detectors to detect, collect, and ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.