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【EXPERT Q&A】What is the basic process for applying for a Class II medical device registration certificate?

Drugdu.com expert’s response: The basic process for applying for a Class II medical device registration certificate is as follows: 1. Product Classification Determination and Preliminary Preparations Confirm Product Classification: Verify that the product falls within the scope of Class II medical devices, either by referring to the “Medical Device Classification Catalog” or by applying to the provincial drug regulatory authority for classification determination (which takes approximately 20 working days). Complete Product Development: Conduct product research and development, trial production, testing, and evaluation. Develop production processes and documentation that meet regulatory requirements. Establish a Quality Management System: Ensure compliance with the “Good Manufacturing Practice (GMP) for Medical Device Production,” covering all aspects such as design and development, production, and inspection. 2. Product Inspection and Clinical Evaluation Full-Performance Inspection: Conduct type testing at a testing institution with CMA/CNAS accreditation (such as provincial medical device testing institutes). The testing cycle typically ranges from ...
- Source: drugdu
- 35
- May 1, 2026
CPhI China 2026

Organiser：Informa Markets Time：June 16 – June 18, 2026 Address：No. 2345 Longyang Road, Pudong New Area, Shanghai Exhibition hall：Shanghai New International Expo Center Product range: Core Raw Materials and Ingredients: Pharmaceutical raw materials, intermediates, fine chemicals, pharmaceutical excipients, veterinary drugs and feed additives, vitamins, amino acids and their derivatives, hormones, antibiotics, antipyretic and analgesic drugs, cardiovascular drugs, central nervous system drugs, respiratory drugs, digestive drugs, anti-parasitic drugs Natural Products and Extracts: Plant extracts, animal extracts, traditional Chinese medicine raw materials, health food raw materials, functional food raw materials, food and beverage raw materials, beauty and cosmetic raw materials Biotechnology and Pharmaceutical Services: Biological products and emerging therapies, peptide drugs, cell therapy, gene editing technology, biotechnology, bioengineering, life science instruments, pharmaceutical outsourcing services, contract customization Preparations and Finished Drugs: Preparations, veterinary drug preparations, respiratory drugs, anesthetic drugs, other western drug raw materials Pharmaceutical Machinery and Equipment: Pharmaceutical machinery and packaging equipment, ...
- Source: drugdu
- 58
- April 30, 2026
【EXPERT Q&A】What conditions are required to apply for a medical device registration certificate?

Drugdu.com expert’s response: The following conditions must be met for the application of a medical device registration certificate: I. Corporate Qualifications and Legitimacy The applicant must be a legally registered enterprise with a corresponding business scope and provide a valid business license. Enterprises involved in production activities are required to hold a Medical Device Production License (some categories may be exempted). For applications from overseas enterprises, it is necessary to provide medical device production qualification certificates and marketing authorization documents from their home countries (regions). II. Quality Management System The enterprise needs to establish a quality management system that complies with medical device production quality management regulations (such as ISO 13485). The system should cover the entire process, including product design, production, inspection, and sales, and be staffed with full-time quality management personnel. Provide quality management system documents, including procedural documents on management responsibilities, resource management, product realization, etc. III. ...
- Source: drugdu
- 48
- April 29, 2026
The world’s first biased GLP-1RA officially enters commercialization.

Today, the world’s first approved cAMP-biased GLP-1 receptor agonist, enoglutide injection (Xianweiying® ) , was simultaneously issued as the first batch of prescriptions nationwide at Peking University People’s Hospital and Zhongshan Hospital affiliated with Fudan University, marking the official entry of this innovative weight management therapy into the clinical application stage in China. Currently, there are two routes for the innovative development of GLP-1 receptor agonists. The traditional route uses GLP-1 as the core target, combined with other targets such as GIP and GCG. The biased signaling mechanism of enoglutin originates from the Nobel Prize-winning research on the structure and function of G protein-coupled receptors (GPCRs). The clinical use of enoglutin reflects a shift in weight management clinical practice from simply focusing on the rate of weight loss to a comprehensive consideration of tolerability, sustainability, and the overall patient experience. Addressing the Challenges of Long-Term Weight Management In recent years, ...
- Source: drugdu
- 60
- April 28, 2026
Breaking News! BeiGene Introduces a PD-1/VEGF Triple Antibody

On April 27, Huahui Anjian announced that it had entered into a global exclusive option, licensing and collaboration agreement with BeiGene for the novel tumor immunotherapy trispecific antibody HH160 , granting BeiGene an exclusive option involving the development, production and commercialization of the product. Under the agreement, BeiGene will pay Huahui Anjian an upfront payment of US$20 million. Huahui Anjian is entitled to an additional US$100 million exercise payment if BeiGene exercises its option. Upon achieving development and regulatory milestones, Huahui Anjian is entitled to payments of up to US$374 million. Upon achieving sales milestones, Huahui Anjian is entitled to payments of up to US$1.53 billion, and is also entitled to tiered licensing fees. In addition, both parties will actively negotiate and discuss BeiGene’s potential participation in Huahui Anjian’s financing, and the specific transaction terms and details will be determined through further negotiation. HH160 is a novel trispecific antibody developed ...
- Source: drugdu
- 59
- April 28, 2026
AstraZeneca’s dual immunotherapy has been approved for marketing in China for a new indication

AstraZeneca recently announced that the China National Medical Products Administration (NMPA) has officially approved durvalumab (trade name: Imfinzi® ) in combination with tramapimab (trade name: Imfinzi® ) for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC). In addition, durvalumab has also been approved as monotherapy for first-line treatment of adult patients with advanced or unresectable HCC. According to the “Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026 Edition),” the number of new cases of primary liver cancer in China in 2022 was 367,700, accounting for 42.5% of global cases; the number of deaths from primary liver cancer in 2022 was 316,500, ranking second in both the number of deaths and the case fatality rate; the 5-year relative survival rate of liver cancer in the Chinese population was 14.4%, and the proportion of patients diagnosed at intermediate or advanced stages reached more than 50%. ...
- Source: drugdu
- 58
- April 28, 2026
A market worth hundreds of billions! Where is the next trump card in the cosmetic injection industry?

Driven by compliance reforms and stricter regulations, the medical aesthetics device industry is poised for a landmark transformation, with the overall market experiencing a dual surge driven by both consumer upgrades and technological advancements. The market size for injectable medical aesthetics products is projected to grow from 67 billion yuan in 2023 to 147 billion yuan in 2027, maintaining a high compound annual growth rate. However, within this multi-billion yuan market, the four main materials exhibit distinct competitive landscapes. This report, compiled by Yaozhi Medical Device Data based on data from multiple sources, systematically describes the size, growth rate, and structural evolution of the medical aesthetic injection product market, the competitive landscape of the four major materials, demand changes, and behavioral analysis. It aims to provide industry participants with data insights and trend analysis to assist in strategic decision-making and resource optimization. 01 Product Overview Injectable cosmetic products primarily achieve ...
- Source: drugdu
- 56
- April 28, 2026
Thirteen Class 1 new drugs have been approved for clinical trials! Innovent, Hansoh, Gan & Lee, and Health-One, among others, have entered the fray

In the past week, China has seen a number of new developments in clinical trial applications for innovative drugs . Data shows that from April 20th to April 26th, 2026, 13 Class 1 new drugs were approved for clinical trials, linked to 19 application numbers. These drugs cover chemical drugs, therapeutic biological products, and traditional Chinese medicine, involving multiple areas such as ADCs, bispecific antibodies, siRNA, small molecule inhibitors, anti-infective drugs, and innovative traditional Chinese medicines. This batch of products includes projects from companies such as Innovent Biologics, Hansoh Pharmaceutical, Gan & Lee Pharmaceuticals, Health-One, and Qilu Pharmaceutical, as well as new developments in innovative traditional Chinese medicine and anti-infective drugs. More noteworthy than the approval of individual products for clinical trials is the simultaneous advancement of different technological approaches to the clinical stage. Antibody drugs remained one of the most active areas last week. Last week, therapeutic biologics projects ...
- Source: drugdu
- 52
- April 28, 2026
The Vietnam Medical Equipment and Pharmaceutical Exhibition (K Med Expo)

Organiser：KINTEX Co., Ltd. Time： June 4 – June 6, 2026 Address：Saigon Exhibition and Convention Center (SECC) Exhibition hall：Lawrence S. Ting Building, 801 Nguyen Van Linh Parkway, Dist. 7, Ho Chi Minh City, Vietnam Product range: Medical Equipment: Diagnostic, examination, and treatment equipment; accident and emergency equipment; diagnostic, disinfection, and disposal systems; electronic medical equipment; medical technology; medical furniture and equipment; rehabilitation equipment; orthopedic supplies; medical consumables; dental materials and equipment. Pharmaceutical Equipment: Pharmaceuticals; machinery, equipment, and technology for the research, development, and production of pharmaceutical materials and packaging; products and equipment provided by R&D departments; beauty equipment, beauty care, and high-quality medical services. About K Med Expo： The Vietnam Medical Equipment and Pharmaceutical Exhibition (K Med Expo) has gradually established itself as the most professional international exhibition in Vietnam’s pharmaceutical and medical fields. Due to its professionalism and high-quality professional visitors, it has attracted an increasing number of ...
- Source: drugdu
- 61
- April 28, 2026
MicroWisdom Bio Completes Nearly RMB 100 Million B+ Round Supplementary Financing, Accelerating Bioartificial Liver Clinical Development and Industrialization

Arterial Network has learned that Shanghai MicroWisdom BioTech Co., Ltd. (hereinafter referred to as “MicroWisdom Bio”), an innovative biomedical enterprise focused on liver disease cell therapy and regenerative medicine, has recently successfully completed nearly RMB 100 million in B+ round supplementary financing. This supplementary round was jointly participated by Fullway Capital, Guangdong Technology Finance Group, Shum Yip Capital, Cuihung Innovation, and Zhongshan Venture Capital. The funds will be primarily used for the clinical development, process optimization, and subsequent pipeline development of the core product HepaCure bioartificial liver, further consolidating the company’s global leading position in the field of liver disease treatment. End-stage liver diseases such as liver failure represent a significant unmet clinical need, and bioartificial livers, as the most promising treatment modality, have become an industry focus. MicroWisdom Bio has been deeply engaged in this track for many years. Leveraging the internationally leading hepatocyte-like cell transdifferentiation technology (hiHep technology), ...
- Source: drugdu
- 60
- April 27, 2026

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