Expert Q&A – media

【EXPERT Q&A】What are the key points and requirements for the product registration application materials of Class II active medical devices?

Drugdu.com expert’s response: I. Requirements for Completeness of Declaration Materials Basic Certification Documents Business License: Submit a copy of the enterprise’s valid business license (with expiration date). Personnel Qualifications: Provide identity certificates and educational/professional title certificates for the legal representative, enterprise负责人 (enterprise leader), and quality manager to verify enterprise and personnel qualifications. Contract Manufacturing: If outsourcing production, submit the contract manufacturer’s Medical Device Production License and the signed contract manufacturing agreement between both parties. Core Product Documents Medical Device Registration Application Form: Detailed description of product name, specifications, model, structure, intended use, production process, and quality control methods. Must be signed and stamped by the legal representative or responsible person. Product Instructions and Label Specimens: Include generic name, model, specifications, manufacturer information, product technical requirement number, production date, expiration date, performance, structure, intended use, contraindications, and precautions. Product Technical Requirements: Specify technical parameters, performance indicators, and testing methods in compliance with national/industry ...
- Source: drugdu
- 32
- October 8, 2025
【EXPERT Q&A】What are the requirements for clinical evaluation of medical devices under the EU MDR ?

Drugdu.com expert’s response: The EU Medical Device Regulation (MDR) aims to ensure the safety and efficacy of medical devices through its requirements for clinical evaluation. The specific requirements are as follows: I. Clinical Evaluation Plan Purpose and Scope: The clinical evaluation plan should clearly outline the objectives, scope, methods, and timeline of the evaluation, taking into account the intended use, risks, and expected clinical outcomes of the medical device. Clinical Data Collection and Analysis: It should describe how clinical data related to the medical device will be collected, analyzed, and evaluated, including the selection of patient populations, data collection methods and time points, and statistical methods for data analysis. Design and Management of Clinical Trials: If clinical trials are required, the plan should detail the design and management of the trials, including participant selection criteria, trial arrangements, duration, supervision, and management. Reporting of Clinical Evaluation Results: It should specify how ...
- Source: drugdu
- 88
- October 6, 2025
【EXPERT Q&A】What does the “generic drug consistency evaluation” marked on Moxifloxacin Hydrochloride Tablets mean?

Drugdu.com expert’s response: The “generic drug consistency evaluation” marked on Moxifloxacin Hydrochloride Tablets indicates that this generic drug has undergone comparative quality and efficacy trials with the original branded drug and has been proven to possess equivalent quality and efficacy. Specific Meaning and Background Definition and Purpose: The generic drug consistency evaluation is a systematic assessment conducted on already-marketed generic drugs. It requires that generic drugs maintain consistency with the original branded drug in terms of active ingredients, dosage forms, specifications, routes of administration, and therapeutic effects. The core objective is to ensure that generic drugs can serve as substitutes for the original branded drugs, delivering the same therapeutic effects while guaranteeing public safety and efficacy in medication use. Policy Background: China initiated the generic drug consistency evaluation program in 2016, aiming to enhance the overall quality of generic drugs through a phased approach to quality consistency evaluation. Drugs that ...
- Source: drugdu
- 44
- October 3, 2025
【EXPERT Q&A】What is the process for CE certification?

Drugdu.com expert’s response: CE certification is a mandatory safety certification for products entering the EU market. Its process aims to ensure that products comply with the basic requirements of the EU’s New Approach to Technical Harmonization and Standardization directives, covering aspects such as safety, health, environmental protection, and consumer protection. Below is a detailed overview of the CE certification process and key points: I. Core Process Steps Determine Applicable Directives and Standards Directive Identification: Based on the product type (e.g., electrical equipment, machinery, medical devices), identify the applicable EU directives, such as: Low Voltage Directive (LVD): Applies to electrical equipment with rated voltages between 50V and 1000V. Electromagnetic Compatibility Directive (EMC): Ensures devices do not interfere with other equipment and are immune to interference. Machinery Directive (MD): Covers all machinery products, including safety components. Standard References: Many directives have corresponding European harmonized standards (EN standards), such as EN 60335 (safety of household ...
- Source: drugdu
- 49
- October 1, 2025
【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
- 59
- 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
- 70
- 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
- 74
- 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
- 76
- 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
- 107
- 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
- 112
- September 17, 2025

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