Expert Q&A – media

【EXPERT Q&A】What materials should be submitted for the registration of Class III medical devices within the country?

Drugdu.com expert’s response: The registration of domestic Class III medical device products in China requires the submission of application materials to the National Medical Products Administration (NMPA). Specifically, the process is handled through its subsidiary, the Center for Medical Device Evaluation (CMDE), which is responsible for the technical review of medical device product registrations. Below is a detailed explanation: I. Submission Authority The registration materials for domestic Class III medical device products must be submitted to the National Medical Products Administration (NMPA). As the competent authority overseeing medical device regulation in China, the NMPA is responsible for the registration approval, quality supervision, and market regulation of medical devices. The Center for Medical Device Evaluation (CMDE), a subsidiary of the NMPA, specifically undertakes the technical review of medical device product registrations. II. Submission Process Preparation of Registration Materials Applicants must prepare a complete set of registration application materials in accordance with ...
- Source: drugdu
- 30
- May 14, 2025
【EXPERT Q&A】How to sterilize medical endoscopes?

Drugdu.com expert’s response: The sterilization of medical endoscopes requires the selection of appropriate methods based on their material, structure, and usage scenarios. Common sterilization methods and their operational key points are as follows: I. Selection of Sterilization Methods 1.Sterilization of Heat and Pressure-Resistant Instruments Applicable Objects: Rigid endoscopes made of stainless steel (e.g., laparoscopes, arthroscopes) and detachable metal components. Sterilization Method: Pressure steam sterilization (at 132°C and 2.1 bar for 3-5 minutes). Operational Key Points: Thoroughly remove organic matter, blood stains, and cleaning solution residues; sterilize in an exposed state (excluding drying time) and avoid stacking instruments; dry immediately after sterilization and hang vertically to prevent mirror surface scratches. 2.Sterilization of Heat-Sensitive Instruments (1) Low-Temperature Plasma Sterilization Applicable Objects: Flexible endoscopes (e.g., gastroscopes, colonoscopes) and optical components. Sterilization Method: Hydrogen peroxide low-temperature plasma sterilization (sterilization cycle of 45-75 minutes). Operational Key Points: Ensure instruments are completely dry before sterilization; follow ...
- Source: drugdu
- 37
- May 12, 2025
【EXPERT Q&A】Huadong Medicine’s marketing application for Semaglutide Injection has been accepted. What are the functions of this drug?

Drugdu.com expert’s response: The efficacy of Semaglutide Injection by East China Pharmaceutical is primarily reflected in the following aspects: Blood Glucose Control: Semaglutide Injection is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. It stimulates insulin secretion in a glucose concentration-dependent manner, inhibits glucagon release, and delays gastric emptying, thereby effectively lowering blood glucose levels. It has significant effects on both fasting and postprandial blood glucose, helping patients with type 2 diabetes mellitus (T2DM) better control blood glucose fluctuations and reduce the damage caused by hyperglycemia. This medication is suitable for T2DM patients who have inadequate blood glucose control despite dietary and exercise modifications. It can significantly improve blood glucose indicators when used alone or in combination with other drugs. Weight Management: Semaglutide can suppress appetite by acting on the central nervous system to modulate neural signals related to food intake, thereby reducing food consumption. Additionally, it delays gastric emptying and ...
- Source: drugdu
- 48
- May 9, 2025
【EXPERT Q&A】What regulations and guiding principles are there for OOS investigations in pharmaceutical enterprises?

Drugdu.com expert’s response: Pharmaceutical companies are required to adhere to a series of regulations and guidelines when conducting investigations into Out-of-Specification (OOS) results. These documents provide a clear framework for the investigation process, responsibility allocation, and subsequent handling. The specifics are as follows: I. Core Regulatory Requirements FDA Regulations 21 CFR Part 211: Clearly stipulates Current Good Manufacturing Practices (CGMP) for pharmaceutical production and quality control, mandating the recording and investigation of any laboratory results that do not meet quality standards. FDA 211.192: Requires thorough investigations into OOS results. Even if a batch is rejected due to OOS, it is still necessary to determine whether the result is associated with other drugs or batches. FDA 211.194: Specifies that written records of investigations must include conclusions and follow-up actions to ensure process traceability. China GMP (Revised 2010 Edition): Article 224 mandates that quality control laboratories establish operating procedures for investigating out-of-specification ...
- Source: drugdu
- 46
- May 7, 2025
【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
- 57
- May 5, 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
- 56
- May 2, 2025
A Comparative Analysis for Global Market Compliance

Drugdu.com expert’s response: CE, UL, and 3C certifications represent distinct certification systems tailored to different markets and standards, with notable differences in scope, certification authorities, testing criteria, processes, and marking requirements. Below is a detailed comparison: I. CE Certification: The “Legal Passport” for the EU Market 1. Fundamental Attributes Legal Mandate: In the EU, the CE mark is a legal requirement for product commercialization—akin to a driver’s license for operating a vehicle. Absence of the mark constitutes a violation. Liability Traceability: Manufacturers must self-declare compliance via technical documentation (risk analysis, test reports, design drawings) and a signed Declaration of Conformity (DoC). EU customs authorities retain traceability to the responsible party. Risk-Tiered Compliance: Low-Risk Products (e.g., general-purpose sockets): Self-declaration under EU harmonized standards (e.g., EN 60884) with 10-year record retention. High-Risk Products (e.g., in vitro diagnostic medical devices): Mandatory type testing and factory audits by EU Notified Bodies (e.g., BSI, DEKRA), with certification ...
- Source: drugdu
- 62
- April 30, 2025
【EXPERT Q&A】What is the reason that the FDA will terminate the regulations on animal trials of monoclonal antibodies?

Drugdu.com expert’s response: The U.S. Food and Drug Administration (FDA) plans to gradually terminate the requirement for animal testing of monoclonal antibodies, primarily based on the following aspects: I. Technological Advancements Offer Alternative Approaches Organoids and Organ-on-a-Chip Technology: These technologies can simulate the physiological functions of human organs, demonstrating high predictability in drug safety testing. For example, liver-on-a-chip models have achieved up to 87% accuracy in predicting drug-induced liver toxicity. Artificial Intelligence and Computational Models: By simulating drug absorption, distribution, metabolism, and excretion (ADME) in the human body, AI models can more accurately predict drug efficacy and toxicity, reducing reliance on animal experiments. Real-World Data: Leveraging existing real-world safety data from other countries to further validate drug performance in humans provides a more reliable basis for drug assessment. II. Limitations of Animal Experiments Species Differences: Animal models exhibit significant physiological and metabolic disparities from humans, making it difficult to extrapolate ...
- Source: drugdu
- 60
- April 28, 2025
【EXPERT Q&A】What is the effect of regorafenil tablets?

Drugdu.com expert’s response: Regorafenib tablets are multi-target tyrosine kinase inhibitors primarily used in the treatment of various solid tumors. They possess anti-angiogenic properties and can inhibit tumor cell proliferation and metastasis. Their specific efficacy includes: I. Treatment of Gastrointestinal Stromal Tumors (GIST) Patient Population: Patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumors who have experienced disease progression or intolerance after previous treatment with imatinib mesylate and sunitinib malate. Mechanism of Action: By inhibiting targets such as KIT, PDGFRα, RET, and VEGFR, it blocks signal transduction pathways in tumor cells, inhibiting tumor growth and angiogenesis. II. Treatment of Hepatocellular Carcinoma (HCC) Patient Population: Patients with hepatocellular carcinoma who have previously received sorafenib treatment. Mechanism of Action: Inhibits targets such as VEGFR, TIE2, PDGFR, and FGFR, reducing tumor angiogenesis and inhibiting tumor growth and spread. III. Treatment of Metastatic Colorectal Cancer (mCRC) Patient Population: Patients with metastatic colorectal cancer who ...
- Source: drugdu
- 59
- April 25, 2025
【EXPERT Q&A】What are the precautions for Chinese and Western medicine at sea?

Drugdu.com expert’s response: When Chinese traditional and Western medicines venture overseas, there are multiple aspects requiring attention, encompassing regulatory compliance, market access, intellectual property protection, and cultural difference management. Below is a detailed analysis: I. Regulatory and Compliance Aspects Target Market Regulations: It is essential to gain an in-depth understanding of the drug regulatory regulations in the target country or region, including requirements for registration, approval, clinical trials, and Good Manufacturing Practice (GMP) for production quality management. For example, the U.S. FDA mandates rigorous clinical trials before a drug can be marketed, while the EU EMA emphasizes compliance with GMP standards in the production process. Different countries have specific requirements for drug ingredients, labels, and instructions, necessitating compliance with local regulations. International Certifications and Standards: Obtaining international certifications (such as WHO prequalification, PIC/S GMP) can enhance product credibility and facilitate market access. Adhering to international quality standards (such as ISO, ICH guidelines) ensures product ...
- Source: drugdu
- 59
- April 23, 2025

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