Expert Q&A – Page 4 – media

【EXPERT Q&A】What conditions are required to apply for a medical device registration certificate?

Drugdu.com expert’s response: The following conditions must be met for the application of a medical device registration certificate: I. Corporate Qualifications and Legitimacy The applicant must be a legally registered enterprise with a corresponding business scope and provide a valid business license. Enterprises involved in production activities are required to hold a Medical Device Production License (some categories may be exempted). For applications from overseas enterprises, it is necessary to provide medical device production qualification certificates and marketing authorization documents from their home countries (regions). II. Quality Management System The enterprise needs to establish a quality management system that complies with medical device production quality management regulations (such as ISO 13485). The system should cover the entire process, including product design, production, inspection, and sales, and be staffed with full-time quality management personnel. Provide quality management system documents, including procedural documents on management responsibilities, resource management, product realization, etc. III. ...
- Source: drugdu
- 126
- April 29, 2026
【EXPERT Q&A】What is the function of a ventilator?

Drugdu.com expert’s response: Ventilators: Core Functions, Clinical Applications, and Technological Advances I. Core Functions: From Physiological Replacement to Organ Protection Ventilators achieve three primary functions through mechanical ventilation: Gas Exchange Replacement When patients cannot maintain adequate oxygenation (PaO₂ < 60 mmHg) or CO₂ elimination (PaCO₂ > 50 mmHg) due to pulmonary diseases (e.g., pneumonia, ARDS) or neuromuscular dysfunction (e.g., spinal cord injury), ventilators directly facilitate gas exchange between alveoli and capillaries by setting tidal volume, respiratory rate, and fraction of inspired oxygen (FiO₂). Example: In ARDS patients, alveolar surfactant deficiency causes widespread atelectasis. Ventilators maintain alveolar patency using positive end-expiratory pressure (PEEP), reducing intrapulmonary shunting and improving oxygenation. Respiratory Muscle Unloading During acute exacerbations of chronic obstructive pulmonary disease (COPD), airway obstruction and intrinsic PEEP increase respiratory workload by 3–5 times normal. Ventilators assume partial or full respiratory effort via positive-pressure ventilation, alleviating muscle fatigue and preventing respiratory failure progression. ...
- Source: drugdu
- 126
- April 27, 2026
【EXPERT Q&A】What documents are required for CE certification?

Drugdu.com expert’s response: CE Certification: Mandatory Safety Certification for Products Entering the EU Market CE certification serves as a mandatory safety certification for products to enter the European Union market, and the preparation of relevant documentation must strictly adhere to EU directives, such as the Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), Medical Device Directive (MDD), etc. I. Core Documents (General Requirements) Technical File Product Description: Include the name, model number, specifications, intended use, and functional descriptions (covering all variant models). Design Drawings: General assembly drawings, component drawings, circuit diagrams (including electrical schematic diagrams and wiring diagrams), and mechanical drawings (if applicable). Risk Assessment Report: Identify risks throughout the product’s lifecycle (e.g., electrical safety, mechanical hazards, biocompatibility) in accordance with ISO 14971 and describe risk control measures. List of Conformity Standards: Clearly specify applicable EU directives (e.g., LVD 2014/35/EU, EMC 2014/30/EU) and harmonized standards (e.g., EN 60601-1, the general ...
- Source: drugdu
- 154
- April 24, 2026
【EXPERT Q&A】What are the ways to query the technical requirements of medical device products?

Drugdu.com expert’s response: Here are the ways to query the technical requirements of medical device products: National Medical Products Administration (NMPA) Official Website Path: Enter the NMPA official website and search through the “Medical Device Standard Catalog Query” or “Compulsory Industry Standards for Medical Devices” sections to retrieve the currently effective catalog of medical device standards. Explanation: As the official regulatory authority for the medical device industry, the NMPA issues regulations and standards with authoritative status. However, some specific document contents may need to be downloaded from other platforms. National Institutes for Food and Drug Control (NIFDC, also known as the Chinese Institute for Food and Drug Control) Official Website Path: Log in to the NIFDC official website, navigate to the “Data Query” section, and select “Medical Device Standard Query.” Explanation: As the standard management center for medical devices under the NMPA, the NIFDC provides a wealth of standard resources, ...
- Source: drugdu
- 145
- April 22, 2026
【EXPERT Q&A】What requirements does the EU in vitro Diagnostic (IVDR) regulation have for product instructions?

Drugdu.com expert’s response: Core Requirements for Product Instructions under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) to Ensure Safety, Effectiveness, and Proper User Application I. Basic Information Requirements Manufacturer and Authorized Representative Information Must include the manufacturer’s full name, address, and the name and address of the EU authorized representative (if the manufacturer is located outside the EU). Example: If the manufacturer is based in China, the EU authorized representative’s contact details must be clearly indicated. Product Identification and Classification Must specify the product name, model number, unique device identifier (e.g., UDI code), and IVD product classification (Class A/B/C/D). Example: The front page of the instructions should clearly state: “Product Name: XX Blood Glucose Meter, Classification: Class B.” CE Marking and Compliance Statement Must include the CE mark and indicate compliance with IVDR requirements. Example: Display “CE 2017/746” prominently on the cover or a visible location, along ...
- Source: drugdu
- 131
- April 20, 2026
【EXPERT Q&A】Is a ventilator the same as an oxygen generator? What’s the difference?

Drugdu.com expert’s response: Ventilators and oxygen concentrators are different, with significant disparities in their functional positioning, working principles, applicable populations, output gases, usage scenarios, and equipment structures, as detailed below: Functional Positioning Ventilator: Primarily used to assist or replace a patient’s respiratory function, helping those unable to breathe autonomously or with inadequate respiratory function to complete breathing movements and maintain airway patency and respiratory function. It is suitable for patients with respiratory failure, apnea, and other respiratory dysfunctions. Oxygen Concentrator: Mainly used to increase the oxygen concentration in inhaled air, providing high-concentration oxygen to hypoxic patients to improve their hypoxic state. It is suitable for individuals who are hypoxic but have basically normal respiratory function, such as patients with chronic obstructive pulmonary disease (COPD) and heart failure. Working Principles Ventilator: It pushes air into the lungs through mechanical force, simulating the human breathing process and regulating the rhythm and depth ...
- Source: drugdu
- 143
- April 17, 2026
【EXPERT Q&A】What should I do with the registration certificate for Class II medical devices?

Drugdu.com expert’s response: Process and Key Points for the Registration of Class II Medical Device Products I. Eligibility Requirements 1. Corporate Qualifications The applicant must be a legally registered enterprise within China, with a business license covering medical device production or operation. The enterprise must have passed GMP certification and possess a quality management system, production facilities, and testing equipment commensurate with its production scale. For imported products, the applicant must provide an Import Medical Device Registration Certificate and information about the authorized agent. 2. Product Requirements The product must comply with national mandatory standards and not be listed on prohibited production or sales lists. Clinical trial conclusions (issued by at least three medical institutions, stating “satisfactory safety and efficacy”) are required. Information such as indications and scope of use must align with the product instructions and regulatory requirements. 3. Personnel and Facilities The enterprise must employ full-time quality management personnel with ...
- Source: drugdu
- 147
- April 15, 2026
【EXPERT Q&A】Is it necessary to conduct environmental test-related inspections during the CE registration of active medical devices?

Drugdu.com expert’s response: Active medical devices typically require environmental test-related inspections during CE registration, which is a necessary step to meet the General Safety and Performance Requirements (GSPR) under the EU Medical Device Regulation (MDR 2017/745) or the older Directive (MDD 93/42/EEC). Below is a detailed analysis of this requirement: I. Regulatory Basis and Core Requirements Regulatory Requirements According to EU medical device regulations, technical documentation must include “evidence of the device’s suitability under normal and extreme environmental conditions.” Environmental testing is a crucial means to demonstrate this, ensuring that the product remains compliant with safety and performance requirements under varying climatic and mechanical stress conditions. Risk Control Electronic components, batteries, sensors, and other parts of active devices (such as monitors and ventilators) are susceptible to factors like temperature, humidity, and vibration. Environmental testing can expose potential defects (e.g., circuit failures, material degradation) in advance, reducing clinical risks. II. Specific ...
- Source: drugdu
- 134
- April 13, 2026
【EXPERT Q&A】What standards need to be followed for clinical performance studies under the EU IVDR regulation?

Drugdu.com expert’s response: Under the EU’s In Vitro Diagnostic Regulation (IVDR), clinical performance studies must adhere to the following core standards to ensure the scientific validity, reliability, and compliance of the study results: I. Regulatory Framework and Core Requirements 1. IVDR Regulation (Regulation (EU) 2017/746) Clinical performance studies must comply with the requirements outlined in Articles 57-77 and Annex XIV of the IVDR, covering aspects such as study design, ethical review, subject protection, and data management. It is necessary to demonstrate the scientific validity, analytical performance, and clinical performance of in vitro diagnostic reagents (IVDs), ensuring their association with specific clinical conditions or physiological states. 2. ISO 20916:2024 Standard Core Role: As a harmonized standard under the IVDR, ISO 20916 provides a comprehensive framework for the planning, design, implementation, documentation, and reporting of clinical performance studies. Key Content: Presumption of Conformity: Compliance with the normative clauses of ISO 20916 is ...
- Source: drugdu
- 129
- April 10, 2026
【EXPERT Q&A】What are the compliance requirements for labels in the EU medical device CE audit?

Drugdu.com expert’s response: In the EU Medical Device CE Certification review, compliance requirements for labeling are of utmost importance to ensure that products conform to relevant regulations and standards. Below is a detailed summary of these requirements: I. Basic Label Content Requirements Product Identification Information: Labels should include essential information such as the product model, batch number, and expiration date to enable regulatory authorities and consumers to accurately understand the product’s information and performance characteristics. Manufacturer Information: The label should clearly indicate the manufacturer’s name, address, as well as the product model and serial number (if applicable). This information aids in tracing the product’s origin and compliance. CE Mark: Products must bear the CE mark in a prominent location, which is a mandatory indication that the product complies with relevant EU regulations. The CE mark should be clearly visible and resistant to wear. Its color is typically white letters on ...
- Source: drugdu
- 136
- April 8, 2026

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