Expert Q&A – Page 2 – media

【EXPERT Q&A】What testing and certification are required for the export of medical device products?

Drugdu.com expert’s response: Medical device export testing and certification requirements are not determined by “export” as a general concept. They mainly depend on the target market + product category + risk classification. The same product may face very different requirements when exported to the EU, the United States, the UK, or Southeast Asia. Generally, the requirements can be assessed from the following aspects: I. Basic General Requirements 1. ISO 13485 Quality Management System Certification ISO 13485 is one of the most common quality management system certifications for medical device companies. It is often recognized by overseas customers, registration authorities, and procurement channels. It is not a “market access certificate” for every country, but it is usually an important basic document for medical device export. ISO 13485 focuses on whether the company has established a quality management system that meets medical device regulatory requirements, including design and development, production control, risk ...
- Source: drugdu
- 76
- May 29, 2026
【EXPERT Q&A】What certifications are required for the export of active pharmaceutical ingredients to Japan?

Drugdu.com expert’s response: I. Mandatory Core Certifications MF (Master File) Registration Authority: Japan PMDA / Ministry of Health, Labour and Welfare (MHLW) Purpose: Full API technical dossier registration, linked review with Japanese pharmaceutical companies Requirement: Must be submitted through a domestic Japanese agent; valid for 5 years AFM (Approved Foreign Manufacturer) Designation Basis: Japan Pharmaceutical and Medical Device Act (PMD Act) Purpose: Legal export qualification for overseas API manufacturers Requirement: Renewed every 5 years; export prohibited without AFM Japan GMP Compliance (MHLW Ordinance No. 179) Basis: ICH Q7 + Japan GMP Method: PMDA on-site inspection Outcome: GMP Compliance Certificate, valid for 5 years II. Required Supporting Documents (Per Batch / Ongoing) Japanese domestic agent (responsible for submission, communication, and handling inquiries) GQP (Good Quality Practice) Quality Agreement (signed with Japanese MAH) Per-batch CoC (Certificate of Compliance) — batch number / specifications / test results / expiry date Certificate of Origin ...
- Source: drugdu
- 81
- May 27, 2026
【EXPERT Q&A】The Difference Between a Ventilator and an Oxygen Concentrator

Drugdu.com expert’s response: Although both contain the word “breathing” in their names, ventilators and oxygen concentrators are two completely different categories of medical devices that solve different problems. In one sentence: A ventilator helps you breathe — when stop working, it does the job for them. An oxygen concentrator helps you get more oxygen — your lungs still work, but the air you breathe in doesn’t contain enough oxygen, so it raises the oxygen concentration for you. Their working principles are completely different. A ventilator uses positive pressure to force gas (air or an air-oxygen mix) into your lungs, or applies pressure during exhalation to help push the air out. It replaces or assists your respiratory muscles (diaphragm, intercostal muscles) and the entire ventilation process. An oxygen concentrator, on the other hand, filters nitrogen out of the air, enriches the oxygen, and outputs high-concentration oxygen (usually above 90%). It does not participate in your breathing ...
- Source: drugdu
- 83
- May 25, 2026
【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
- 86
- 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
- 89
- 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
- 73
- 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
- 96
- 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
- 91
- 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
- 98
- 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
- 121
- May 8, 2026

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