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【EXPERT Q&A】What is the development process of a qualified medical device?

Drugdu.com expert’s response: The development process of a qualified medical device typically includes the following key steps: Ⅰ. Preliminary Preparations Business Registration: Register the company and clarify the business scope to prepare for future product production ranges and avoid subsequent changes. Team Formation: Establish a professional and efficient R&D team, including talents in mechanical engineering, electrical engineering, software engineering, etc., to ensure the technical feasibility of the product. Ⅱ. Product Development and Design Product Requirement Determination: Conduct market research, clinical application scenario analysis, doctor visits, etc., by the product manager to clarify the product’s functional requirements, performance requirements, and user expectations. System Requirement Determination: Convert product requirements into engineering technical indicators, complete the division of system functional architecture and constituent components, and output related requirements for regulations and standards, risk and safety, usability, serviceability, and manufacturability. R&D and Design: Based on system requirements, carry out structural design, sampling verification, and ...
- Source: drugdu
- 22
- December 23, 2024
Yingtai Medical acquires Weiqiang Medical

Yingtai Medical (01501. HK) recently announced that the company has signed a letter of intent to acquire its target company Hangzhou Weiqiang Medical Technology Co., Ltd. and its affiliated group companies on December 18, 2024. According to the terms of the agreement, Yingtai Medical plans to acquire at least 51% of the controlling stake in Weiqiang Medical through capital increase, share expansion, and acquisition of shares from some shareholders. This transaction also stipulates that Yingtai Medical will inject no less than RMB 200 million in new funds into Weiqiang Medical after the acquisition is completed, and must pay a prepayment of RMB 30 million after the agreement takes effect. Weiqiang Medical has attracted much attention for its outstanding product development and clinical integration capabilities. In its product line, it includes Professor Guo Wei’s WeFlow Branch split type thoracic aortic stent graft from 301 Hospital, and Professor Fu Weiguo’s Fabulous stent ...
- Source: drugdu
- 39
- December 21, 2024
4 innovative medical devices approved for market launch

Recently, the National Medical Products Administration approved the registration applications for four innovative products: Changsha Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as “Changsha Huiwei Intelligent”)’s “Intestinal Polyp Electronic Lower Digestive Endoscopy Image Assisted Detection Software”, Shanghai Minimally Invasive Melody Medical Technology Co., Ltd. (hereinafter referred to as “Minimally Invasive Melody”)’s “Spinning Intervention Therapy Device” and “Disposable Coronary Spinning Grinding Catheter”, and Hunan Aptech Medical Equipment Co., Ltd. (hereinafter referred to as “Aptech Medical”)’s “Disposable Magnetoelectric Positioning Pressure Monitoring Pulse Electric Field Ablation Catheter”.  Changsha Huiwei Intelligence, another heavyweight product approved Changsha Huiwei Intelligent was established in 2020 and is a wholly-owned subsidiary of Suzhou Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as “Huiwei Intelligent”). Huiwei Intelligent was established in June 2019, specializing in the research and development, production, and sales of intelligent medical products. Driven by independent core technologies in the fields of “artificial ...
- Source: drugdu
- 40
- December 21, 2024
Once a month, potential “best-in-class” lipid-lowering drugs apply for listing

Today, LIB Therapeutics announced that it has submitted a biologics license application (BLA) to the U.S. FDA, seeking approval for its third-generation PCSK9 inhibitor lerodalcibep to lower low-density lipoprotein cholesterol (LDL-C) to treat patients with atherosclerotic cardiovascular disease (ASCVD), as well as patients with very high or high ASCVD risk and primary hyperlipidemia (including heterozygous and homozygous familial hypercholesterolemia, HeFH/HoFH). At the same time, LIB Therapeutics is preparing to submit a marketing application (MAA) to the European Medicines Agency (EMA), which is expected to be completed in mid-2025. Cardiovascular disease (CVD) affects hundreds of millions of people worldwide, and the number of related deaths exceeds the sum of cancer, chronic lung disease and diabetes. It is estimated that by addressing the factors that cause or aggravate CVD, about 80% of premature deaths caused by CVD can be prevented. ASCVD accounts for approximately 85% of all cardiovascular deaths. ASCVD is caused ...
- Source: drugdu
- 36
- December 21, 2024
Notice! Xinma Pharmaceutical Recruitment and Procurement Involved in Bribery

The results of the credit evaluation of pharmaceutical recruitment have come out again, and the companies and varieties involved in bribery have also been announced. On December 9, the Shandong Provincial Public Resources Trading Center issued the “Announcement on the Pharmaceutical Price and Procurement Credit Evaluation Results of Shenyang Xinma Pharmaceutical Co., Ltd.” Guiding Opinions” (Mibaofa [2020] No. 34), “Operating Standards for Pharmaceutical Prices and Recruitment Credit Ratings (2020 Edition)”, “Discretionary Benchmarks for Pharmaceutical Prices and Recruitment Credit Ratings (2020 Edition)”, Shandong Provincial Public Resources Under the guidance of the Shandong Provincial Medical Insurance Bureau, the trading center conducts credit rating assessments on pharmaceutical prices and behaviors that are inconsistent with good faith in the list of untrustworthy matters in recruitment and procurement. Along with the announcement, “About Shenyang Xinma Pharmaceutical Co., Ltd. Medicine Price and Recruitment Credit Evaluation Results” was released. The content showed that the type of untrustworthy ...
- Source: drugdu
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- December 21, 2024
New weight loss drug, the world’s first cAMP-biased GLP-1 agonist has been submitted for marketing

On December 16, Xinweida Bio announced that the company’s application for marketing authorization for the new indication of the Class 1 new drug Ecnoglutide Injection was accepted by the CDE for long-term weight management of adult patients on the basis of controlling diet and increasing physical activity. Ecnoglutide Injection is the world’s first new long-acting GLP-1 agonist with cAMP bias independently developed by Xinweida Bio. Its three China Phase III registered clinical studies on adult type 2 diabetes and obesity have been successfully completed, and some results have been published at the American Diabetes Congress and the European Diabetes Congress. The completed clinical data confirmed that Ecnoglutide Injection has excellent therapeutic effects on patients with type 2 diabetes and obesity, and shows good safety and tolerability. In November this year, the indication of Ecnoglutide for blood sugar control in adult patients with type 2 diabetes has been submitted for marketing. ...
- Source: drugdu
- 37
- December 21, 2024
The president of a century-old Chinese medicine hospital was investigated and was boycotted for his identity as a Western medicine doctor

One year after his retirement, Zuo Guoqing, former member of the Party Committee and president of Chongqing Chinese Medicine Hospital, was investigated for suspected serious violations of discipline and law. Recently, the Chongqing Municipal Commission for Discipline Inspection and Supervision announced this news. Public information shows that Zuo Guoqing is 61 years old, a chief physician, professor, doctoral supervisor, master of medicine and master of business administration, and an expert enjoying special government allowances from the State Council. He has worked in the field of gastroenterology for more than 20 years and served as the vice president of the Second Affiliated Hospital of Chongqing Medical University. He has a profound influence in the medical field in Chongqing. Since 2012, Zuo Guoqing has been transferred to the president of Chongqing Chinese Medicine Hospital. Chongqing Chinese Medicine Hospital is a century-old hospital with a history of more than 120 years. It is ...
- Source: drugdu
- 32
- December 21, 2024
Adhere to Innovation and High Quality Promotion of New Drug Research and Development

Recently, a reporter from China Securities Journal visited the Xinda Biotech Global R&D Center (Medical) in person. The research and development center is located in the New Hongqiao International Medical Center in the Hongqiao Business District of Shanghai, and was officially opened in August this year. Relying on the national strategy of integrating the Yangtze River Delta, Xinda Biotechnology has formed a three in one coordinated development situation of Suzhou headquarters, Shanghai R&D center, and Hangzhou industrialization base. Xinda Biotech has been deeply involved in the field of innovative drugs for more than ten years, including the first PD-1 inhibitor to be included in the national medical insurance catalog (Daboshu), the world’s first GCG/GLP-1 dual receptor agonist, Masidopeptide, and the first domestically developed PCSK9 inhibitor, Trastuzumab Injection (Xinbile). Looking ahead to the future, Qian Lei, Senior Vice President of Clinical at Xinda Biotechnology, stated in an interview with China Securities ...
- Source: drugdu
- 37
- December 21, 2024
The new technology route of two major single product vaccines of Aimei vaccine has obtained clinical approval

On December 19th, Aimei Vaccine announced that its two major single product vaccine new technology routes, suspension cultured MDCK cell influenza vaccine and second-generation high-efficiency adsorption tetanus vaccine, have both obtained the “Drug Clinical Trial Approval Notice” from the National Medical Products Administration. These are two significant developments made by the Emmy vaccine during the intensive declaration period, which are expected to bring new growth points. According to the announcement, currently all influenza vaccines listed in China are produced using chicken embryo technology, and no cell-based influenza vaccine has been approved for market. The MDCK cell influenza vaccine approved for clinical use has significantly improved product quality and safety compared to traditional chicken embryo influenza split vaccines. The MDCK cells developed by Aimei have characteristics such as easy cultivation, fast proliferation, and susceptibility to influenza virus. By culturing influenza virus on a large scale in MDCK cells, higher yields, more ...
- Source: drugdu
- 44
- December 21, 2024
The stone medicine AI has exploded

Shiyao Group has once again achieved a heavyweight business development. Recently, Shiyao announced that it has reached a BD agreement with BeiGene regarding the group’s new methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH2039, granting BeiGene the global development and commercialization rights for the pipeline. And the amount of BD this time is also very astonishing: Shiyao Group will receive a total advance payment of $150 million, and has the right to receive up to $135 million in potential development milestone payments and up to $1.55 billion in potential sales milestone payments, as well as tiered sales commissions calculated based on the annual net sales of the product. It is worth mentioning that the compound was selected by Shiyao through AI technology. Previously, Shiyao also provided AstraZeneca with a high priced BD through a preclinical pipeline screened by AI technology. The stone medicine AI has exploded. 01 Why is it stone medicine? ...
- Source: drugdu
- 59
- December 20, 2024

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