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【EXPERT Q&A】Why Class II and Class III medical devices should be registered?

Drugdu.com expert’s response: The registration of Class II and Class III medical devices is primarily based on the following reasons: I. Legal and Regulatory Requirements The “Regulations on the Supervision and Administration of Medical Devices” clearly stipulate that Class II and Class III medical devices must undergo registration management, and medical devices that have not undergone registration are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, and enterprises must comply with it to ensure legal operations. II. Risk Level Management Medical devices are classified into three categories based on their risk levels, with Class II and Class III belonging to medium and high-risk levels, respectively. Class II medical devices, such as thermometers, sphygmomanometers, and electrocardiographs, may lead to misdiagnosis, mistreatment, or cause certain harm to patients if there are issues with their quality or safety. ...
- Source: drugdu
- 251
- March 19, 2025
First proof, first installment! Two medical devices approved for market launch

Recently, the injectable hydroxyapatite microsphere facial filler (registration certificate number: National Medical Device Approval No. 20253130390) applied by Shanghai Moyang Biotechnology Co., Ltd. has been approved for market by the National Medical Products Administration. At the same time, Merz North America Inc., a subsidiary of Merz North America Inc., which is represented by Merz Business Management Consulting (Shanghai) Co., Ltd., also obtained market approval on March 10, 2025 for the injectable hydroxyapatite microsphere facial filler produced by Merz North America Inc. (Registration number: National Medical Device Injection No. 20253130124). 1st domestically produced product Shanghai Moyang Biotechnology Co., Ltd.’s injectable hydroxyapatite calcium phosphate microsphere facial filler is the first officially approved hydroxyapatite based facial injection filler material in China, suitable for subcutaneous injection in the nasolabial folds to correct moderate to severe nasolabial folds. According to publicly available information, the main components of this product are: calcium hydroxyphosphate, sodium carboxymethyl cellulose, ...
- Source: drugdu
- 228
- March 18, 2025
“Gastrointestinal Endoscopic Surgical Instrument Control Equipment” is approved for market launch

Recently, the National Medical Products Administration approved the registration application for the innovative product “Gastrointestinal Endoscopic Surgical Instrument Control Equipment” of Shenzhen Robb Medical Technology Co., Ltd. (hereinafter referred to as Robb Medical). Fill the domestic gap Founded in 2015, Robb Medical is a medical robot research and development enterprise that has entered the industrialization stage. Since its establishment, it has been committed to the technological research and development of flexible digestive endoscopic surgical robots, and is currently the earliest surgical robot company in the world to enter the industrialization stage in this field. After years of development, Robb Medical has become a hub for technology and talent in the field of medical robotics. It has accumulated certain technologies in the manufacturing of rehabilitation robots, flexible robotic arms, parallel surgical robot design and control, force feedback, machine vision, automatic surgery, and has taken the lead in using these technologies in ...
- Source: drugdu
- 298
- March 18, 2025
Levosalbutamol Hydrochloride Nebulized Inhalation Solution Obtains Drug Registration Certificate

On March 14, Luoxin Pharmaceuticals issued an announcement stating that its subsidiary Luoxin Anruovita Pharmaceuticals (Chengdu) Co., Ltd. received the “Drug Registration Certificate” for Levosalbutamol Hydrochloride Nebulized Inhalation Solution approved and issued by the State Drug Administration. Levosalbutamol is a β2-adrenergic receptor agonist that can relax all airway smooth muscles from the trachea to the terminal bronchioles. Levosalbutamol Hydrochloride Nebulized Inhalation Solution is suitable for the treatment or prevention of bronchospasm caused by reversible airway obstructive diseases in adults and children over 6 years old. The original developer of Levosalbutamol Hydrochloride Nebulized Inhalation Solution was Sepracor Inc. of the United States. It was launched in the United States in 1999 under the trade name: XOPENEX. The original formulation has not yet been imported into China. The company’s salbutamol hydrochloride nebulized inhalation solution has obtained a drug registration certificate according to the new registration classification of chemical drugs, Class 3, and ...
- Source: drugdu
- 249
- March 18, 2025
Obtained the Drug Registration Certificate for Taijilidine Fumarate Injection

On March 16, Hengrui Medicine (600276.SH) announced that the company received the “Drug Registration Certificate” for Taijilidine Fumarate Injection approved and issued by the National Medical Products Administration, approving the company’s independently developed Class 1 innovative drug Taijilidine Fumarate Injection to add new indications and merge and revise the instructions. The indication is for the treatment of moderate to severe postoperative pain. The drug is a μ opioid receptor-biased small molecule agonist, which was approved for marketing in China in January 2024. It is suitable for moderate to severe pain after abdominal surgery and is China’s first independently developed Class 1 opioid analgesic innovative drug. As of now, the cumulative R&D investment in related projects is approximately RMB 197.91 million. https://finance.eastmoney.com/a/202503163346884091.html
- Source: drugdu
- 242
- March 18, 2025
Expected to Significantly Reduce Losses in 2024

AIM Vaccine announced on the Hong Kong Stock Exchange in the morning of March 17 that it expects to significantly reduce losses in performance. It is expected to record unaudited revenue of between 1.25 billion and 1.3 billion during the reporting period, an increase of 60 million to 110 million from the previous year’s revenue of 1.19 billion, an increase of 5% to 9%, and an unaudited net loss of between 250 million and 290 million yuan, a significant reduction of 1.66 billion to 1.7 billion from the previous year’s net loss of 1.95 billion yuan, a reduction of 85% to 87%. The board of directors initially believes that the increase in revenue is mainly due to the increase in the company’s hepatitis B vaccine revenue, and the reduction in comprehensive net losses is mainly due to the reduction in the amount of large asset impairment losses and the increase in ...
- Source: drugdu
- 260
- March 18, 2025
China’s first and the world’s second IGF-1R antibody drug approved for marketing

Good news for patients with thyroid eye disease! Tetuinumab N01 injection (trade name “Synbimin”), the first IGF-1R antibody drug in China and the second in the world developed by Innovent Biologics, was approved for marketing by the National Medical Products Administration (NMPA) on March 14 for the treatment of thyroid eye disease (TED). “The protracted course of thyroid eye disease seriously affects the patient’s visual function and appearance, and can bring a heavy psychological burden to the patient. At present, glucocorticoids are the first choice for the treatment of thyroid eye disease in China, but their efficacy in treating exophthalmos is limited and has obvious adverse reactions. Biologics targeting IGF-1R can significantly improve the symptoms of exophthalmos in patients with thyroid eye disease and improve their quality of life, and are bound to play an important role in the treatment of thyroid eye disease.” Professor Fan Xianqun, an academician of ...
- Source: drugdu
- 414
- March 18, 2025
Iran PHARMA

Organiser:Iran Pharmaceutical Industry Union Time:September 24 – 26, 2025 Address:Mashad Fair Ground Exhibition hall:Mashad Fair Ground Product range: Pharmaceutical Machinery: Pharmaceutical production equipment, water treatment equipment for pharmaceuticals, traditional Chinese medicine processing equipment, refrigeration equipment, etc. Packaging Equipment and Materials: Aluminum-plastic packaging machines, filling machines, tablet pressing machines, labeling machines, inkjet printers, anti-counterfeiting printing and packaging, packaging production lines, barcode composite technology equipment, self-adhesive printing and packaging equipment, plastic packaging products, packaging container forming, filling, and sealing machines, cartoning machines, bagging machines, multi-functional bottling machines, glass packaging products, and production equipment for pharmaceutical packaging materials, etc. Laboratory Equipment/Analytical Testing: Laboratory equipment and devices, laboratory consumables, chemical reagents, biochemical/analytical instruments, biotechnology analytical testing instruments, pharmaceutical testing equipment, food analysis and testing instruments, analytical instruments for the pharmaceutical industry, etc. Fluid Equipment: Sanitary pumps, valves, fluid engineering, piping and fittings, microfiltration, ultrafiltration, etc. Cleanroom Systems: Cleanroom air conditioning equipment, clean workbenches/stations, ...
- Source: drugdu
- 445
- March 18, 2025
Breaking the Waves with “Dao, Fa, and Shu”

In the vast sea of stars in the biopharmaceutical industry, Novartis is like a giant ship sailing through the wind and waves, with technological innovation as the sail and strategic determination as the anchor, opening up a unique route. Recently, a reporter from Shanghai Securities News walked into the headquarters and R&D center of Nuotai Biotechnology, and through a conversation with the company’s chairman Tong Ziquan, explored the growth logic of this science and technology innovation board enterprise. In recent years, Novartis has made significant achievements in the fields of peptides, oligonucleotides, and small molecule pharmaceuticals. The company has overcome the challenge of large-scale production of long-chain peptides, and with the increasing volume of products such as semaglutide, its demand for peptide raw material procurement will significantly increase in 2024. At the same time, the company has been forward-looking in the field of oligonucleotides since 2022 and has rapidly formed ...
- Source: drugdu
- 282
- March 17, 2025
World First! One innovative medical device approved for market launch

Recently, the National Medical Products Administration approved the registration application for the innovative product “Transcatheter Tricuspid Ring Forming System” of Shanghai Huihe Medical Technology Co., Ltd. (hereinafter referred to as Huihe Medical). Rich pipelines, multiple pioneering products launched Huihe Medical was founded in 2019 and is a world leading cardiovascular intervention platform company with independent innovation capabilities. At present, Huihe Medical has four major platforms including delivery systems, clinical medical technology, precision manufacturing, and global marketing, all of which have industry-leading advantages. We have independently developed and world leading related products in the fields of heart valve intervention, vascular intervention, electrophysiological intervention, drug delivery intervention, and intelligent intervention. The K-Clip approved for listing this time ® The transcatheter tricuspid annuloplasty system is the world’s first transcatheter tricuspid annulus repair system independently developed by Huihe Medical, filling the gap in the field of tricuspid valve intervention in China and used to ...
- Source: drugdu
- 382
- March 17, 2025

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