Expert Q&A – Page 2 – media

【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
- 97
- 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
- 152
- 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
- 147
- 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
- 163
- 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
- 44
- 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
- 158
- 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
- 162
- 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
- 168
- August 29, 2025
【EXPERT Q&A】How to handle the filing for Class I medical device products?

Drugdu.com expert’s response: Medical Device Class I Product Filing Process I. Pre-Filing Preparation Confirm Product Classification Ensure the product falls within the scope of the Class I Medical Device Product Catalog or the In Vitro Diagnostic Reagent Classification Sub-Catalog. If the product is outside these catalogs, apply to the National Medical Products Administration (NMPA) for classification determination. Filing can proceed only after confirmation as a Class I medical device. Prepare Filing Documents The following core materials must be submitted (subject to local regulatory requirements): Filing Form: Completed and stamped with the enterprise’s official seal or signed by the legal representative. Enterprise Qualification Documents: Business license duplicate. Legal representative’s identification. Product Technical Documents: Product Technical Requirements (prepared per the Guidelines for Drafting Technical Requirements for Medical Devices), specifying functional and safety indicators, as well as testing methods. Product Inspection Report (self-tested or commissioned testing, including product information, testing basis, and results). Instructions for Use and Label Samples (compliant ...
- Source: drugdu
- 141
- August 27, 2025
【EXPERT Q&A】Are quality management systems in the medical device industry effective?

Drugdu.com expert’s response: The quality management system (QMS) in the medical device industry is not only valuable but also a core element in ensuring product safety and effectiveness, meeting regulatory requirements, enhancing corporate competitiveness, and promoting the healthy development of the industry. Its importance is reflected in the following aspects: Ensuring Patient Safety and Product Effectiveness Risk Control: Medical devices directly interact with the human body, and quality defects can lead to severe health risks (e.g., surgical instrument fractures, implant failures, diagnostic device misdiagnoses). The QMS reduces risks to acceptable levels through systematic risk assessments (e.g., Failure Mode and Effects Analysis, or FMEA), design controls, and production process monitoring. Performance Verification: Rigorous testing and validation (e.g., biocompatibility testing, electrical safety testing, performance stability testing) ensure that products meet their intended purposes and prevent medical accidents caused by functional failures. Meeting Global Regulatory and Compliance Requirements International Standard Mandates: Major global ...
- Source: drugdu
- 140
- August 25, 2025

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