Expert Q&A – Page 4 – media

【EXPERT Q&A】What materials or documents are needed for a medical device registration certificate?

Drugdu.com expert’s response: The materials required for applying for a medical device registration certificate cover multiple aspects, including enterprise qualifications, product technology, quality control, clinical evaluation, and compliance declarations. The specifics are as follows: Application Form: Fill out the Medical Device Registration Application Form, ensuring that the information is accurate and complete. It should cover basic product information, the registration applicant, and the intended use of the product, among other details. Proof Documents: Copies of the business license and organization code certificate (newly registered enterprises may use the unified social credit code instead and may not need to provide the organization code certificate separately) to prove the legal operation of the enterprise. Identity proofs and copies of educational or professional qualification certificates for the legal representative, enterprise leader, and quality leader to confirm the identities and qualifications of key enterprise personnel. A list of technical personnel along with copies of ...
- Source: drugdu
- 175
- September 29, 2025
【EXPERT Q&A】What regulatory requirements does the EU IVDR have for self-testing and point-of-care testing products?

Drugdu.com expert’s response: The EU In Vitro Diagnostic Regulation (IVDR) imposes comprehensive and stringent regulatory requirements on self-testing and point-of-care testing (POCT) products, covering aspects such as classification management, technical documentation, labeling and instructions, conformity assessment, and post-market surveillance. The specifics are as follows: I. Classification Management: Scientific Risk-Based Grading The IVDR classifies in vitro diagnostic products into four categories—A, B, C, and D—with risk levels increasing sequentially. Self-testing products are typically categorized as Class C, with the following exceptions: Class B Self-Testing Products: Examples include pregnancy tests, ovulation tests, cholesterol detection reagents, and tests for glucose, red blood cells, white blood cells, and bacteria in urine. Class C or D Special Self-Testing Products: Products used to detect sexually transmitted pathogens, blood or tissue typing, or where erroneous results could lead to death or severe disability may be classified as Class C or D. II. Technical Documentation and Performance Evaluation: ...
- Source: drugdu
- 141
- September 26, 2025
【EXPERT Q&A】What regulations should be known for the international registration of medical devices?

Drugdu.com expert’s response: International Regulatory Framework and Core Requirements for Medical Device Registration I. Regulatory Systems in Major Target Markets United States (FDA) Legal Basis: Federal Food, Drug, and Cosmetic Act (FD&C Act). Risk-Based Classification: Class I (Low Risk): Examples include surgical blades and bandages. Typically requires enterprise registration and product listing; some products are exempt from 510(k). Class II (Moderate Risk): Examples include ultrasound devices and infusion pumps. Requires 510(k) submission (demonstrating substantial equivalence to a predicate device) or De Novo classification request. Class III (High Risk): Examples include cardiac pacemakers and artificial joints. Requires Pre-Market Approval (PMA) with clinical trial data and production facility inspection reports. Quality System: Must comply with FDA QSR (21 CFR Part 820), covering design controls and production process validation. Special Requirements: High-risk products require clinical trials to verify safety and efficacy; some products need animal testing data. European Union (MDR/IVDR) Legal Basis: Medical Devices Regulation (MDR ...
- Source: drugdu
- 127
- September 24, 2025
【EXPERT Q&A】What are the difficulties in applying for CE under the EU in vitro Diagnostic (IVDR) regulation?

Drugdu.com expert’s response: I. Complex Classification Rules The IVDR expands the risk classification of in vitro diagnostic products from four categories (e.g., List A/B under IVDD) to four classes (A-D), with criteria spanning sample types (e.g., saliva, skin tissue) and disease risks (e.g., infectivity, mortality). For example: Class D devices (e.g., HIV or COVID-19 test kits) require submission of a Clinical Performance Study Plan (CPSR) and independent testing by EU Reference Laboratories (EURLs). Class C devices (e.g., tumor biomarker tests) necessitate enhanced performance evaluations and clinical evidence reviews. Challenge: Insufficient understanding of classification rules may lead to errors in technical documentation or clinical strategies, requiring costly compliance adjustments. Elevated Clinical Evidence Requirements The IVDR mandates more comprehensive clinical evidence, including: Scientific Validity: Verification of the product’s correlation with specific diseases, conditions, or parameters. Analytical Performance: Demonstration of sensitivity, specificity, and other metrics through laboratory testing. Clinical Performance: Validation of intended use via real-world data. Case ...
- Source: drugdu
- 122
- September 22, 2025
【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
- 155
- 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
- 147
- 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
- 171
- 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
- 196
- 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
- 194
- 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
- 219
- September 8, 2025

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