Expert Q&A – media

【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
- 38
- 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
- 49
- 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
- 67
- 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
- 69
- 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
- 79
- 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
- 80
- May 1, 2026
【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
- 84
- 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
- 79
- 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
- 92
- 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
- 88
- April 22, 2026

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