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【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
- 47
- 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
- 48
- 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
- 75
- May 1, 2025
Tiankang Bio plans to list its animal vaccine business separately on the Beijing Stock Exchange

April 30th, regarding the company’s business integration planning, Tiankang Bio said during an institutional survey on April 29 that the company’s business involves feed, pig farming, animal vaccines, agricultural products, etc., which are all part of the livestock industry chain, and there is a certain degree of synergy between the various business segments. Among them, the animal vaccine business has a relatively high technical content and requires high technological innovation and research and development. The company plans to list this business separately on the Beijing Stock Exchange to obtain more resource support. The correlation between feed and breeding businesses is very high, and the integration of these two businesses will become higher and higher in the future, and may be integrated. The agricultural products business mainly provides raw material supporting services for the feed business. https://finance.eastmoney.com/a/202504303394308111.html
- Source: drugdu
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- May 1, 2025
Kangle Guard’s operating income in 2024 fell by 50.2%, and its losses expanded to 357 million yuan

On April 29, Kangle Guard (833575) announced its 2024 annual report. The company’s operating income was 890,000 yuan, a year-on-year decrease of 50.2%; the net profit attributable to the parent company changed from a loss of 301 million yuan in the same period last year to a loss of 357 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 314 million yuan in the same period last year to a loss of 363 million yuan, and the loss amount further expanded; the net operating cash flow was -125 million yuan, a year-on-year increase of 30.7%; EPS (fully diluted) was -1.2693 yuan. In the fourth quarter, the company’s operating income was 270,000 yuan, up 49.9% year-on-year; the net profit attributable to the parent company changed from a loss of 76.04 million yuan in the same ...
- Source: drugdu
- 50
- May 1, 2025
Stem cell therapy leads the transformation of Japanese medicine

In 2006, stem cell scientist Shinya Yamanaka was awarded the 2012 Nobel Prize in Physiology or Medicine for reprogramming adult cells into induced pluripotent stem cells (iPS cells). Based on this achievement, researchers across Japan are cultivating cells into retinal strips, myocardial slices, or neuronal clusters in order to treat blindness, repair the heart, and reverse neurodegenerative diseases. Early clinical trials suggest that these cells may indeed be useful for treating different conditions such as Parkinson’s disease or spinal cord injury. Now, after nearly two decades of arduous efforts and numerous setbacks, Japan hopes to bring these therapies to the market. According to the journal Nature, there are over 60 ongoing clinical trials of iPS cells worldwide, with nearly one-third conducted in Japan. Clinical breakthrough in eye diseases In 2014, ophthalmologist Masahiro Takahashi from Kobe Eye Hospital first used cells derived from iPS cells to treat macular degeneration. She extracted ...
- Source: drugdu
- 73
- April 30, 2025
Ruizhi Pharmaceutical’s loss in 2024 was reduced to 226 million yuan, and its operating income fell by 14.8%

On April 28, Ruizhi Pharmaceutical (300149) announced its 2024 annual report. The company’s operating income was 970 million yuan, a year-on-year decrease of 14.8%; the net profit attributable to the parent company changed from a loss of 908 million yuan in the same period last year to a loss of 226 million yuan, and the loss amount decreased; the net profit attributable to the parent company after deducting non-recurring items changed from a loss of 911 million yuan in the same period last year to a loss of 236 million yuan, and the loss amount decreased; the net operating cash flow was 168 million yuan, a year-on-year increase of 11.4%; EPS (fully diluted) was -0.4548 yuan. In the fourth quarter, the company’s operating income was 252 million yuan, a year-on-year decrease of 13.9%; the net profit attributable to the parent company changed from a loss of 867 million yuan in ...
- Source: drugdu
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- April 30, 2025
Renmin Pharmaceutical’s revenue in 2024 is 25.435 billion yuan, and the controlling shareholder’s reorganization is about to be implemented

On the evening of April 28, Renmin Pharmaceutical disclosed its 2024 annual report. The company achieved operating income of 25.435 billion yuan for the whole year, a year-on-year increase of 3.71%; net profit attributable to the parent company was 1.33 billion yuan. The first quarter report on the same day showed that the company’s current operations continued to be stable, with operating income of 6.137 billion yuan; net profit attributable to the parent company was 540 million yuan, a year-on-year increase of 11.09%. In addition, the bankruptcy reorganization of the company’s controlling shareholder Contemporary Group is progressing smoothly. The announcement shows that the reorganization plan has been approved by the court. After the reorganization is implemented, China Merchants Group’s China Merchants Innovation and Technology may become a strategic investor in the listed company. The financial report shows that in 2024, Renmin Pharmaceutical’s net profit attributable to the parent company decreased ...
- Source: drugdu
- 57
- April 30, 2025
Tasly’s pharmaceutical industry revenue grew steadily in the first quarter

On the evening of April 28, Tasly (600535) released its first quarter report for 2025. During the reporting period, the company achieved pharmaceutical industry revenue of 1.842 billion yuan, a year-on-year increase of 1.83%. The company achieved a net profit of 314 million yuan attributable to its parent company in the first quarter, a year-on-year increase of 6.47%. In the first quarter, the company’s traditional Chinese medicine sector achieved revenue of 1.469 billion yuan, a year-on-year increase of 1.90%. On March 28, the company announced that the transfer and registration of shares between the original controlling shareholder Tasly Group and its concerted actors and China Resources Sanjiu and Guoxin Investment has been completed. China Resources Sanjiu became the company’s controlling shareholder, and the actual controller was changed to China Resources Co., Ltd. With the completion of the transaction, Tasly also announced major adjustments to the board of directors and the ...
- Source: drugdu
- 56
- April 30, 2025
Hualan Vaccine’s net profit attributable to the parent company in the first quarter was 32.78 million yuan, a year-on-year decrease of 15.1%

On April 27, Hualan Vaccine (301207) announced the first quarter report of 2025. The company’s operating income was 24.28 million yuan, a year-on-year decrease of 29.0%; the net profit attributable to the parent company was 32.78 million yuan, a year-on-year decrease of 15.1%; the net profit attributable to the parent company after deducting non-recurring items was 15.42 million yuan, a year-on-year increase of 8.9%; the net cash flow from operations was -2.59 million yuan, a year-on-year decrease of 102.7%; EPS (fully diluted) was 0.0545 yuan. As of the end of the first quarter, the company’s total assets were 7.443 billion yuan, a decrease of 1.1% from the end of the previous year; the net assets attributable to the parent company were 6.048 billion yuan, an increase of 0.6% from the end of the previous year. The company mainly focuses on the research and development, production and sales of biological vaccines, ...
- Source: drugdu
- 53
- April 30, 2025

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