Expert Q&A – Page 3 – media

【EXPERT Q&A】What Are the Specific Requirements for Equivalence Demonstration Under the EU MDR?

Drugdu.com expert’s response: EU MDR stipulates in Annex XIV that if a manufacturer wishes to cite the clinical data of a marketed device (predicate device) to support its own clinical evaluation, it must first prove equivalence between the two devices. MDR assesses this on a dimension-by-dimension basis across technical characteristics, biological characteristics, and clinical characteristics, and the overall requirements are significantly stricter than the old MDD regulation. The core principle is: the two devices must be “used under similar conditions”, meaning there are no significant clinical differences in safety and clinical performance. I. Technical Characteristics MDR requires the manufacturer to prove that the two devices are highly similar in terms of technology, with the core being “used under similar conditions.” The specific items to compare include: Design and specification performance: The design principles and physical/chemical properties should be similar. Key performance parameters such as energy intensity, tensile strength, viscosity, surface characteristics, wavelength, ...
- Source: drugdu
- 105
- May 22, 2026
【EXPERT Q&A】What standards are there for quality management in medical device enterprises?

Drugdu.com expert’s response: Quality management is the one thing you simply cannot avoid in the medical device industry. From domestic to international, from production to distribution, from risk to software — every link is governed by its own set of standards. Let’s walk through them by actual business scenarios, not by boring categories. First, the Two Hardest Rules in China The one for manufacturing is called GMP (Good Manufacturing Practice). The latest version is NMPA Announcement No. 107 of 2025, effective November 1, 2026. It nearly doubles the number of clauses compared to the old version — expanded from 8 chapters to 15. The core message in one sentence: from R&D to the factory gate, every step must be monitored, documented, and traceable. The management representative and quality head must be full-time, and the quality department holds a veto right. The one for distribution is called GSP (Good Supply Practice). The latest version is NMPA ...
- Source: drugdu
- 100
- May 20, 2026
【EXPERT Q&A】What Documents Are Required for Transitioning a Class III Medical Device from R&D to Production?

Drugdu.com expert’s response: Moving from R&D to production is essentially a “handoff” — turning laboratory technology into repeatable, controllable, and traceable mass production capability on the factory floor. The process involves a large number of documents, which are organized below by logical flow. Block 1: Documents That “Define the Product” This block answers the question: “What exactly are we making, and what standards must it meet?” First is the Product Technical Requirements, which is the core attachment of the registration certificate. It specifies all performance indicators, allowable tolerances, and test methods. All quality inspection activities on the production side are based on this document. Next are the Design & Development Input/Output documents, including intended use, functional and performance requirements, safety requirements, and applicable national/industry standards. This is the starting point for all design work. Then comes the Risk Management Report. In accordance with YY 0316 (ISO 14971), risk analysis, risk evaluation, and risk ...
- Source: drugdu
- 86
- May 18, 2026
【EXPERT Q&A】What are the characteristics of medical device clinical trials compared to drug clinical trials? What are the differences between the two?

Drugdu.com expert’s response: Characteristics of Medical Device Clinical Trials 1. Extreme Product Diversity Active devices, passive implants, in vitro diagnostic (IVD) reagents, software, imaging equipment… each category requires nearly completely different trial protocols, endpoint definitions, and operational procedures. 2. Results Are Highly Operator-Dependent This is the most prominent feature of device trials. Especially for surgical and implantable devices: the same product operated by different surgeons can yield drastically different outcomes. Therefore, the technical proficiency, training, and consistency of investigators are critical. You could say the trial results are co-determined by “the doctor + the device.” 3. More Flexible but Often Simpler Designs Common designs include parallel, paired, crossover, and single-arm. But many devices lack suitable controls, cannot be blinded (surgical devices/large equipment are very hard to blind), or are ethically unsuitable for randomization — so a large proportion are single-arm/single-group trials. Protocols are typically much “thinner” than drug trials. 4. ...
- Source: drugdu
- 106
- May 15, 2026
【EXPERT Q&A】How to apply for and obtain the production and operation license for Class III medical devices?

Drugdu.com expert’s response: Class III Medical Device Production License → Apply to the Provincial Drug Administration Class III Medical Device Operation License → Apply to the Municipal Drug Administration Both require compliant premises, qualified personnel, a quality management system, and a traceability system. Statutory approval period: 20 working days. Validity: 5 years. I. Production License (Provincial Drug Administration) 1. Application Requirements Corporate Qualification: Legal corporate entity; business scope must cover the corresponding production category. Premises & Environment: Production facilities and cleanroom environment must match the product standards. Personnel: Production, Quality, and Technical Directors must hold a relevant major, a college degree or above, and at least 3 years of experience. Inspection personnel and equipment must be fully staffed. Equipment & Documentation: Production and inspection equipment must be complete. Quality manual, procedure documents, and process flowcharts must be fully prepared. Product Registration: The Medical Device Registration Certificate must already be obtained. 2. Required Materials Medical Device ...
- Source: drugdu
- 106
- May 13, 2026
【EXPERT Q&A】What factors should be focused on when analyzing the benefits and risks of medical devices?

Drugdu.com expert’s response: The benefit-risk analysis of medical devices is a core component in ensuring their safety and effectiveness, requiring a comprehensive consideration of multidimensional factors encompassing science, clinical practice, ethics, and society. The following are the key factors that should be prioritized during the analysis: I. Intended Use and Performance of Medical Devices Target Patient Population Clearly define the age, gender, disease stage, or health status of patients for whom the device is suitable (e.g., children, pregnant women, elderly individuals, or patients with specific diseases). Evaluate differences in benefits and potential risks among different patient groups (e.g., children’s higher sensitivity to certain materials). Core Functions and Performance Indicators The primary therapeutic or diagnostic functions of the device (e.g., surgical robots, implantable cardiac pacemakers, in vitro diagnostic reagents). Accuracy, sensitivity, and specificity of performance parameters (e.g., false-positive/false-negative rates of diagnostic reagents). Reliability (e.g., mechanical failure rate, software stability) and durability ...
- Source: drugdu
- 108
- May 11, 2026
【EXPERT Q&A】How to apply for a drug business license? What conditions are needed?

Drugdu.com expert’s response: The process and requirements for obtaining a Pharmaceutical Trading License are as follows: I. Application Process 1. Preparation of Application Materials Pharmaceutical Trading License Application Form: Fill in the enterprise’s basic information and application details truthfully. Copy of the Enterprise’s Business License or Name Pre-approval Notice. Personnel Qualification Certificates: Identity certificates, academic certificates, and professional title certificates of the legal representative, enterprise leader, and quality leader. The quality leader must provide a licensed pharmacist registration certificate (for retail enterprises, the quality leader must be a licensed pharmacist). Qualification certificates for personnel engaged in drug inspection, maintenance, and other positions. Site Proof Materials: Property ownership certificates or lease agreements for the business premises and warehouse. Floor plans of the business premises and warehouse, indicating functional areas such as the pending inspection area, qualified area, and unqualified area, in compliance with the Good Supply Practice for Pharmaceutical Products (GSP). ...
- Source: drugdu
- 137
- May 8, 2026
【EXPERT Q&A】What is the process for the production filing of Class I medical devices?

Drugdu.com expert’s response: The process for filing the production of Class I medical devices is as follows: 1. Corporate Qualification Preparation Legal Business License: The enterprise must possess a valid business license, with its business scope covering the production of medical devices. Production Conditions: Ensure that the enterprise has the necessary production conditions, including the configuration of hardware facilities such as factory premises, equipment, and personnel. 2. Product Classification Confirmation Class I Confirmation: Confirm that the product falls under the category of Class I medical devices by referring to the “Medical Device Classification Catalog” or consulting regulatory authorities for confirmation. Re-confirmation upon Changes: If there are changes in the product’s function or intended use, re-confirm its classification to avoid misclassification. 3. Filing Document Preparation Core Documents: Class I Medical Device Production Filing Form Product Technical Requirements Document: Clearly specifying performance indicators and testing methods. Production Quality Management Documents: Demonstrating the ...
- Source: drugdu
- 114
- May 6, 2026
【EXPERT Q&A】Under the EU MDR regulation, what rules are used to determine the classification of medical devices?

Drugdu.com expert’s response: Under the EU Medical Device Regulation (Regulation (EU) 2017/745), the classification of medical devices is primarily based on their intended use and inherent risks, following a detailed set of classification rules that categorize medical devices into four classes: Class I, Class IIa, Class IIb, and Class III. Below are the core principles and logic of this classification system: I. Core Principles of Classification Risk Stratification: The higher the risk level, the stricter the classification and regulatory requirements. Intended Use as the Primary Factor: Classification is based on the manufacturer’s declared intended use, without considering misuse or abuse scenarios. Highest Risk Applies When Multiple Rules Apply: If a single device is subject to multiple classification rules, it is classified according to the rule with the highest risk. Key Factors: Invasiveness, Duration of Use, Active/Non-Active, and Site of Action: Invasiveness: Non-invasive, through body orifices, surgical invasive, implantable. Duration of ...
- Source: drugdu
- 149
- May 4, 2026
【EXPERT Q&A】What is the basic process for applying for a Class II medical device registration certificate?

Drugdu.com expert’s response: The basic process for applying for a Class II medical device registration certificate is as follows: 1. Product Classification Determination and Preliminary Preparations Confirm Product Classification: Verify that the product falls within the scope of Class II medical devices, either by referring to the “Medical Device Classification Catalog” or by applying to the provincial drug regulatory authority for classification determination (which takes approximately 20 working days). Complete Product Development: Conduct product research and development, trial production, testing, and evaluation. Develop production processes and documentation that meet regulatory requirements. Establish a Quality Management System: Ensure compliance with the “Good Manufacturing Practice (GMP) for Medical Device Production,” covering all aspects such as design and development, production, and inspection. 2. Product Inspection and Clinical Evaluation Full-Performance Inspection: Conduct type testing at a testing institution with CMA/CNAS accreditation (such as provincial medical device testing institutes). The testing cycle typically ranges from ...
- Source: drugdu
- 111
- May 1, 2026

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