Expert Q&A – Page 4 – media

【EXPERT Q&A】What are the functions of the FDA’s consensus standards for medical devices and how can they be queried?

Drugdu.com expert’s response: I. Functions: Regulating Safety and Effectiveness of Medical Devices and Accelerating Market Access Ensuring Safety and Effectiveness The consensus standards recognized by the FDA provide clear specifications for the design, testing, and clinical evaluation of medical devices through scientifically validated test methods, acceptance criteria, and risk management processes. For example, biocompatibility standards (such as the ISO 10993 series) stipulate safety testing requirements for materials in contact with human tissues, ensuring that products do not trigger toxicity or allergic reactions. Streamlining Regulatory Processes Manufacturers who can demonstrate that their products comply with FDA-recognized consensus standards can reduce redundant testing and document submissions, thereby shortening the pre-market review time. For instance, in a 510(k) application, products that meet consensus standards can expedite approval through “substantial equivalence” demonstration. Enhancing Industry Transparency Consensus standards offer a unified framework for performance indicators and labeling instructions, facilitating the understanding of product characteristics by ...
- Source: drugdu
- 149
- September 19, 2025
【EXPERT Q&A】Specifically, what are Class II medical devices?

Drugdu.com expert’s response: Class II medical devices refer to medical devices with moderate risk that require strict control and management to ensure their safety and effectiveness. Below is a detailed explanation of Class II medical devices: I. Definition and Risk Level Definition: Class II medical devices are those whose safety and effectiveness should be controlled. These devices are typically used for the prevention, diagnosis, monitoring, treatment, or alleviation of diseases in human organs, tissues, or body fluids outside the body, employing various technological means and potentially posing a moderate risk to humans. Risk Level: The risk level of Class II medical devices falls between that of Class I low-risk medical devices and Class III high-risk medical devices. Class I medical devices have a low degree of risk and can be managed through routine measures to ensure their safety and effectiveness. In contrast, Class III medical devices carry a higher risk ...
- Source: drugdu
- 143
- September 17, 2025
【EXPERT Q&A】What certifications are required for the export of medical devices and pharmaceutical products?

Drugdu.com expert’s response: Medical devices and pharmaceutical products require multiple certifications for export based on the requirements of target markets, covering international standards, regional regulations, and special product specifications. Below is a detailed explanation: I. International General Certifications ISO Certifications ISO 13485: An international standard for the quality management system of medical devices, serving as a foundational certification for exports. It proves that a company’s production processes comply with international norms. ISO 9001: A general quality management system certification. While not mandatory, it enhances corporate credibility. GMP Certification Good Manufacturing Practice certification ensures that production processes meet international standards, particularly for pharmaceutical-grade medical devices (e.g., vaccines, injectables). II. Regional Mandatory Certifications EU Market CE Certification: The “passport” for entering the EU market, classified by risk level: Class I low-risk products (e.g., surgical scalpels): Require a CE Declaration of Conformity. Class I*, IIa, IIb, and III high-risk products (e.g., implantable devices, pacemakers): Require ...
- Source: drugdu
- 161
- September 15, 2025
【EXPERT Q&A】What are the advantages and disadvantages of oncolytic virus therapy compared with other immunotherapies (such as CAR-T, PD-1 inhibitors)?

Drugdu.com expert’s response: Oncolytic virus (OV) therapy demonstrates outstanding performance in terms of broad-spectrum efficacy, cost-effectiveness, and the ability to reverse the tumor immune microenvironment. However, it faces limitations in administration methods and infection efficiency, necessitating combination with other therapies to overcome single-agent constraints. CAR-T therapy exhibits remarkable efficacy in hematological malignancies but is associated with high costs, limited effectiveness in solid tumors, and elevated risks of side effects. PD-1 inhibitors offer convenience and maturity in application but suffer from low response rates and are constrained by tumor immune phenotypes. Below is a detailed comparison of oncolytic virus therapy with other immunotherapies, such as CAR-T and PD-1 inhibitors: Advantages of Oncolytic Virus Therapy Broad-Spectrum Efficacy and Tumor Microenvironment Remodeling: Oncolytic viruses can target a variety of solid tumors, including liver cancer, melanoma, and ovarian cancer, and are particularly adept at transforming “cold tumors” (with low immune cell infiltration) into “hot tumors.” By ...
- Source: drugdu
- 189
- September 12, 2025
【EXPERT Q&A】Under the EU MDR regulation, what key requirements should be met to prove the equivalence of medical devices?

Drugdu.com expert’s response: Under the framework of the EU MDR (Medical Device Regulation), proving the equivalence of medical devices requires constructing an argumentation system from three major dimensions: technical characteristics, biological characteristics, and clinical characteristics, to ensure that there are no significant differences in safety, performance, and clinical effectiveness between the declared device and the already-marketed device. Here are the specific requirements and analyses: I. Technical Characteristics: Ensuring Consistency in Functional Principles and Usage Conditions Similarity in Usage Conditions The declared device and the already-marketed device must be used under similar conditions, meaning there are no significant clinical differences in safety and clinical performance. For example, blood glucose meters should maintain consistent measurement accuracy and stability in different medical institutions (such as tertiary hospitals and community clinics) or when used by different patient groups (such as elderly and young diabetic patients). Regulatory Basis: The MDR requires compliance with the MEDDEV ...
- Source: drugdu
- 188
- September 10, 2025
【EXPERT Q&A】What are the specific principles and mechanisms of action of pancreatic enzymes in digesting cells?

Drugdu.com expert’s response: The core principle of trypsin-mediated cell digestion lies in its proteolytic activity and enzyme-substrate specificity, enabling cell separation by breaking down cell-cell adhesion proteins. The specific mechanisms and actions are as follows: I. Composition and Enzymatic Properties of Trypsin Trypsin is a complex enzyme secreted by the pancreas, primarily containing trypsin, lipase, and amylase. In cell culture, trypsin is the key component responsible for digestion, with the following characteristics: Proteolytic Activity Trypsin, a serine protease, specifically cleaves peptide bonds at the carboxyl terminus of lysine (Lys) or arginine (Arg) residues in protein molecules. This cleavage action breaks down large proteins into smaller fragments, disrupting their three-dimensional structures. Enzyme-Substrate Specificity Trypsin exclusively acts on specific amino acid linkages (e.g., Lys/Arg-X bonds), ensuring that only proteins are digested while other cellular components such as nucleic acids and lipids remain unaffected. This specificity is determined by the active site structure ...
- Source: drugdu
- 209
- September 8, 2025
【EXPERT Q&A】The Critical Necessity of Usability Engineering Reports for Medical Devices

Drugdu.com expert’s response: The usability engineering report for medical devices holds immense significance as it serves as a pivotal element in ensuring product safety, efficacy, compliance, and market competitiveness. The following analysis unfolds across four key dimensions: regulatory requirements, product risk control, user experience optimization, and enhancement of market competitiveness. I. Regulatory Mandates: The “Passport” to Compliance International Regulatory Framework FDA (United States): Mandates that medical device design adheres to the “human-computer interaction safety principle.” 21 CFR Part 820 explicitly stipulates the necessity of usability testing to validate design rationality, with non-compliance potentially leading to product recalls or market access hindrances. EU MDR (European Union): Incorporates “usability engineering” into the General Safety and Performance Requirements (GSPR), requiring manufacturers to furnish documentation on user interface design, risk analysis, and user testing as essential materials for CE certification. ISO 14971: This international risk management standard explicitly mandates the inclusion of “use errors” ...
- Source: drugdu
- 78
- September 5, 2025
【EXPERT Q&A】What is the outlook for medical CDMO?

Drugdu.com expert’s response: The medical Contract Development and Manufacturing Organization (CDMO) industry boasts a broad prospect and is now at a critical juncture of transitioning from “scale expansion” to “value creation”. Technological innovation, green production, and global layout will be the keys for enterprises to break through. The specific analysis is as follows: I. Demand Side: Expansion of Global Pharmaceutical R&D Pipelines and Growth Driven by Emerging Therapies Continuous Growth of Global R&D Pipelines In 2025, the number of global pharmaceutical R&D pipelines will surpass 25,800, representing a year-on-year increase of 4.6%, with biologics accounting for over 60%. This trend directly drives the recovery of CDMO demand, particularly for small-molecule CDMOs (which are returning to growth after shaking off the high base effect of COVID-19 orders) and peptide CDMOs (which have become one of the fastest-growing sectors due to the explosion of the GLP-1-based antidiabetic drug market). Emerging Therapies Reshaping ...
- Source: drugdu
- 189
- September 3, 2025
【EXPERT Q&A】In what aspects is trimethylolpropane used?

Drugdu.com expert’s response: Trimethylolpropane (TMP), as a critical fine chemical product, demonstrates extensive application value across multiple industrial sectors. Its core uses can be summarized as follows: I. Resin Synthesis: A Key Raw Material for Enhancing Material Performance Alkyd and Polyurethane Resins: TMP serves as a cornerstone raw material for synthesizing alkyd and polyurethane resins. Its three hydroxymethyl groups enable cross-linking reactions with organic acids or diisocyanates, significantly improving resin hardness, abrasion resistance, chemical resistance, and weatherability. For example, in automotive coatings, TMP-containing resins enhance UV and acid rain resistance, extending vehicle lifespan. Unsaturated Polyester and Epoxy Resins: As a chain extender or cross-linker, TMP increases polymer molecular weight, enhancing mechanical properties (e.g., tensile strength, impact resistance) and thermal stability. It is widely applied in aerospace, electronics, and other high-end fields. Coatings and Inks: Optimizing Performance and Processes Coatings Industry: TMP is a vital component in high-performance coatings, improving drying ...
- Source: drugdu
- 208
- September 1, 2025
【EXPERT Q&A】What are the development trends of the complex formulation industry?

Drugdu.com expert’s response: Development Trends in the Complex Formulation Industry I. Complex formulation processes will gain broader development opportunities Formulation innovation can extend the lifecycle of new molecular entities while enhancing the safety, efficacy, and patient compliance of existing products, making it a focal point of pharmaceutical R&D. For instance, conventional leuprolide formulations have gradually been phased out, whereas leuprolide microspheres remain a first-line treatment for prostate cancer and uterine fibroids. In 2022, the market size of leuprolide microspheres in China reached approximately RMB 4.8 billion, with steady year-on-year growth. China’s 14th Five-Year Plan for the Pharmaceutical Industry emphasizes the need to prioritize the development of complex formulation technologies for chemical drugs, including high-selectivity, long-acting controlled-release injectables (e.g., microspheres) and oral formulations such as controlled-release and multi-particulate systems. Enterprises mastering innovative complex formulation processes are poised to stand out and secure greater profit margins. II. Significant potential for import substitution by domestic ...
- Source: drugdu
- 203
- August 29, 2025

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