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【EXPERT Q&A】What are the differences between the Class II filing and the Class III license for medical devices?

Drugdu.com expert’s response: Key Differences Between Class II Medical Device Filing and Class III Medical Device Licensing in China: Risk Tiers, Regulatory Approaches, Scope, Application Processes, and Oversight Intensity Medical devices in China are categorized into Class II (moderate risk) and Class III (high risk), with distinct regulatory frameworks governing their filing and licensing. Below is a detailed analysis of their disparities: I. Distinctions Between Class II Filing and Class III Licensing 1. Risk Tiers and Regulatory Approaches Class II Medical Devices: Risk Profile: Moderate risk, requiring stringent controls to ensure safety and efficacy. Regulatory Mechanism: Managed through a filing system, emphasizing post-market accountability. Class III Medical Devices: Risk Profile: High risk, with potential for severe health consequences. Regulatory Mechanism: Subject to pre-market licensing, necessitating rigorous pre-approval scrutiny. 2. Scope of Application Class II Medical Devices: Intended for extracorporeal prevention, diagnosis, monitoring, treatment, or alleviation of diseases. Examples include thermometers, sphygmomanometers, and hearing aids. Class ...
- Source: drugdu
- 102
- May 5, 2025
The “insulin leader” saw a 1150% surge in net profit

On April 25, Ganli Pharmaceutical, a leading insulin company, released its first quarter report for 2025, reporting an excellent performance with both revenue and net profit growing. According to the report, the company’s Q1 operating income reached 985 million yuan, a year-on-year increase of 75.76%; net profit attributable to shareholders of listed companies reached 312 million yuan, a year-on-year increase of 224.9%; net profit attributable to shareholders after deducting non-recurring items reached 215 million yuan, a year-on-year increase of 1150.2%. From the perspective of revenue structure, Gan & Lee Pharmaceuticals achieved significant growth in both domestic and overseas revenue, which jointly drove the increase in overall revenue. In the domestic market, Ganli Pharmaceuticals performed strongly, with sales revenue reaching 889 million yuan, an increase of 395 million yuan over the same period last year, a year-on-year increase of 80.07%. This is mainly due to the substantial increase in sales of ...
- Source: drugdu
- 96
- May 5, 2025
Yahong Pharmaceutical’s loss in the first quarter widened to 83.53 million yuan

On April 29, Yahong Pharmaceutical (688176) announced its first quarter report for 2025. The company’s operating income was 61.10 million yuan, up 151.2% year-on-year; the net profit attributable to the parent company changed from a loss of 82.85 million yuan in the same period last year to a loss of 83.53 million yuan, and the loss amount further expanded; the net profit attributable to the parent company after deducting non-recurring items changed from a loss of 93.23 million yuan in the same period last year to a loss of 89.35 million yuan, and the loss amount decreased; the net operating cash flow was -110 million yuan, up 14.5% year-on-year; EPS (fully diluted) was -0.1465 yuan. As of the end of the first quarter, the company’s total assets were 2.162 billion yuan, down 2.8% from the end of the previous year; the net assets attributable to the parent company were 1.891 ...
- Source: drugdu
- 110
- May 5, 2025
the core of stem cell therapy is safety, effectiveness and quality control

Shanghai Securities News (reporter Liu Yipeng) “At the beginning of this year, the first stem cell drug in China was approved for listing, marking a new stage of standardization and standardization of the industry. At present, many stem cell varieties have entered phase II and phase III clinical trials. Hainan Boao Music City International Medical Tourism Pioneer Zone has passed the policy of” first trial first “, providing an important test ground for clinical transformation.” On April 25, at the 2025 Boao Stem Cell Industry Conference, Wang Guangji, an academician of the CAE Member and professor of China Pharmaceutical University, said in an exclusive interview with reporters from Shanghai Securities News that the core of stem cell therapy is safe, effective and quality controllable, and only through strict standards. Only the stem cell products produced in chemical production, reviewed by the drug supervision department and clinically verified can truly benefit ...
- Source: drugdu
- 104
- May 4, 2025
The incidence of vaccine-preventable diseases is rising

According to the official website of the World Health Organization (WHO) on April 24, during the “World Immunization Week” held from the 24th to the 30th, WHO, UNICEF and the Global Vaccine Immunity Alliance jointly issued a warning that due to the spread of misinformation and the reduction of international aid, diseases that could have been prevented by vaccines, such as measles, meningitis and yellow fever, are on the rise worldwide. The three major international organizations urgently called on countries to continue to invest political attention and funds to consolidate the results of immunization programs and safeguard the significant progress made in reducing child mortality in the world over the past half century. The latest monitoring data show that measles cases have increased year by year since 2021. In 2023, there were 10.3 million cases, an increase of 20% from 2022. In the past 12 months, 138 countries have reported ...
- Source: drugdu
- 96
- May 4, 2025
Innovative vaccines are accelerating their approval and listing, and the Bio-Vaccine ETF (562860) is expected to benefit

As of 10:42 on April 24, 2025, the CSI Vaccine and Biotechnology Index rose by 0.36%, and its constituent stocks Rongchang Bio rose by 4.38%, Maiwei Bio rose by 4.27%, Qianhong Pharmaceutical rose by 3.47%, Hitech Bio rose by 2.89%, and North China Pharmaceutical rose by 2.33%. The Bio-Vaccine ETF (562860) is in a stalemate between long and short positions. The Bio-Vaccine ETF closely tracks the CSI Vaccine and Biotechnology Index. The CSI Vaccine and Biotechnology Index selects no more than 50 listed companies whose businesses involve vaccine research and development, vaccine production, vaccine consumables, vaccine production equipment and other biotechnology fields as samples to reflect the overall performance of listed companies with vaccine and biotechnology themes. Data shows that as of March 31, 2025, the top ten weighted stocks in the CSI Vaccine and Biotechnology Index are Zhifei Bio, Wantai Bio, Watson Bio, Hualan Bio, Kangtai Bio, BeiGene, Junshi ...
- Source: drugdu
- 85
- May 3, 2025
A symposium on improving the drug safety responsibility system was held in Beijing

On April 25, in order to thoroughly implement the deployment of the Third Plenary Session of the 20th CPC Central Committee and study and improve the drug safety responsibility system, the State Drug Administration held a symposium in Beijing on April 25. Experts and scholars from industry associations, colleges and universities, research institutions in the fields of medicine and administrative management discussed and exchanged ideas and measures to strengthen drug safety responsibility governance from theoretical and practical perspectives, and put forward opinions and suggestions on improving the drug safety responsibility system. The meeting required in-depth research and demonstration, fully listening to the opinions of all parties, identifying the key directions and key links of improving the drug safety responsibility system, studying specific measures that are targeted, operational and effective, and actively promoting the continuous improvement of the drug safety responsibility system. https://finance.eastmoney.com/a/202504253389252011.html
- Source: drugdu
- 86
- May 3, 2025
【EXPERT Q&A】How long does it take to obtain a registration certificate for Class II medical devices?

Drugdu.com expert’s response: Timeline for Class II Medical Device Registration in China: Typically 6–12 Months, Influenced by Clinical Trial Requirements, Documentation Quality, Technical Review Complexity, and Regional Variations The duration for obtaining a Class II medical device registration certificate in China generally ranges from 6 to 12 months, with specific timelines contingent on factors such as clinical trial needs, completeness of application materials, technical review intricacies, and regional disparities. Below is a detailed breakdown: 1. Exemption from Clinical Trials For products eligible for clinical trial exemption, the registration timeline typically spans 6 to 8 months. These products require submission of comprehensive technical documentation, quality management system (QMS) files, and non-clinical research data. The technical review primarily focuses on evaluating the product’s safety, efficacy, and quality controllability. 2. Requirement for Clinical Trials Products mandated to undergo clinical trials face an extended registration period of 10 to 12 months. The clinical trial phase alone takes 6 to ...
- Source: drugdu
- 97
- May 2, 2025
The Indonesia Jakarta Medical Equipment Exhibition (INDO HEALTH CARE)

Organiser：KRISTA EXHIBITIONS Time：August 6–8, 2025 address：Jl. Jend. Gatot Subroto No.1, RT.1/RW.3, Gelora, Kecamatan Tanah Abang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270, Indonesia Exhibition hall：Balai Sidang Jakarta Convention Center Product range: Medical Devices: Diagnostic medical equipment, Traditional Eastern medicine therapies and devices, Dental instruments and equipment, Clinical examination instruments, Obesity treatment and wellness devices, Ophthalmic medical instruments Rehabilitation and Medical Equipment: Surgical instruments and devices, Therapeutic instruments and equipment, Radiological medical devices, Hospital facilities and emergency equipment, Central supply systems, Asian medical practices and devices, Rehabilitation and wellness products, Disposable instruments and equipment, Other medical-related products Medical Supplies and Hygiene Materials: Ward Care Equipment and Appliances: Beds, trolleys, examination tables, cabinets, shelving, etc. Sterilization Products: Medical air sterilizers, vacuum sterilizers, ultrasonic cleaning systems, disinfectants/agents, etc. Auxiliary Products: Oxygen concentrators, ventilators, blood pressure monitors, glucometers, thermometers, potential therapy devices, radiation protection gear, oxygen supply equipment, blood bank facilities, medical ...
- Source: drugdu
- 73
- May 1, 2025
Fosun Pharma changes its leader! Taking over from Wu Yifang, Chen Yuqing becomes the chairman of Fosun Pharma

On April 29, Fosun Pharma (600196.SH; 02196.HK) announced its first quarter performance report for 2025. On the same day as the first quarter report was released, Fosun Pharma announced the adjustment of the division of labor of the board of directors. After this adjustment, Wu Yifang will no longer serve as the executive director and chairman of Fosun Pharma, but will be the non-executive director of Fosun Pharma and will serve as the executive president of Fosun International; Wang Kexin will no longer serve as the co-chairman of Fosun Pharma, but will continue to serve as the executive director of Fosun Pharma and will serve as the executive president of Fosun International; Chen Yuqing will serve as the chairman and executive director of Fosun Pharma, Guan Xiaohui will serve as the co-chairman and executive director of Fosun Pharma, and CEO Wen Deyong will serve as the vice chairman and executive ...
- Source: drugdu
- 114
- May 1, 2025

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