Expert Q&A – Page 3 – media

【EXPERT Q&A】What are the requirements for applying to operate Class II medical devices?

Drugdu.com expert’s response: The application for a Class II medical device operating license must meet key requirements across four dimensions: enterprise qualifications, personnel allocation, facility conditions, and quality management systems. I. Enterprise Legal Qualifications Legal Person Status The applicant must possess valid legal person status, and the enterprise must be registered with the industrial and commercial authorities and hold a valid business license. Registered Capital and Scale The registered capital shall generally be no less than RMB 1 million (specific amounts may vary by regional policies and should comply with local requirements). The enterprise scale must align with its business scope to ensure capacity for fulfilling corresponding responsibilities. Registered Address and Premises The registered address must be an independent business venue with a floor area of no less than 80 square meters, separate from the residential address. The operating premises must comply with national laws and regulations, providing adequate space for storing medical ...
- Source: drugdu
- 155
- October 22, 2025
【EXPERT Q&A】What are the functions and roles of a ventilator?

Drugdu.com expert’s response: A ventilator is a medical device capable of replacing, controlling, or modifying a patient’s spontaneous breathing movements, providing mechanical ventilation support. Its core function is to maintain effective gas exchange, ensuring oxygen supply and carbon dioxide removal while reducing the workload on respiratory muscles. Below are the key functions and roles of ventilators: I. Core Functions Ventilation Support Replacing Spontaneous Breathing: When respiratory failure occurs due to disease, trauma, or anesthesia, ventilators can fully or partially replace pulmonary ventilation to ensure gas exchange. Adjusting Respiratory Parameters: By setting parameters such as tidal volume (air volume per breath), respiratory rate, and inspiratory-to-expiratory ratio, ventilators precisely control ventilation volume to avoid hyperventilation or hypoventilation. Oxygenation Support Increasing Blood Oxygen Levels: By delivering high concentrations of oxygen (adjustable FiO₂), ventilators correct hypoxemia (e.g., in pneumonia, ARDS, or cardiogenic pulmonary edema). Positive Pressure Ventilation: Utilizing airway positive pressure (e.g., CPAP, BiPAP ...
- Source: drugdu
- 165
- October 20, 2025
【EXPERT Q&A】Are there any side effects of semaglutide?

Drugdu.com expert’s response: I. Common Side Effects Digestive System: Nausea, vomiting, diarrhea, bloating (often caused by gastrointestinal irritation or delayed gastric emptying). Metabolic Issues: Hypoglycemia may occur when used with insulin (monitor blood glucose and carry sugar supplements). Allergic Reactions: Rash, itching, or severe cases like difficulty breathing (discontinue use immediately and seek medical attention). Injection Site: Pain, redness, or hard lumps (ensure proper disinfection and rotate injection sites). Other: Headache, dizziness, or rapid heartbeat (consult a doctor if symptoms persist). II. Serious Risks (Require Vigilance) Pancreatitis: Sudden severe upper abdominal pain with vomiting (contraindicated in patients with a history of pancreatitis). Thyroid Disorders: Animal studies suggest potential increased tumor risk (contraindicated in those with a family history of thyroid cancer). Diabetic Retinopathy: May trigger or worsen the condition (regular eye exams recommended). III. Usage Reminders Contraindicated Groups: Type 1 diabetes, pregnancy/breastfeeding, or severe kidney disease. Regular Monitoring: Blood glucose, ...
- Source: drugdu
- 148
- October 17, 2025
【EXPERT Q&A】What should be noted when registering a medical device for the first time?

Drugdu.com expert’s response: When undertaking medical device registration for the first time, particular attention should be paid to the following aspects to ensure compliance with the process and enhance the approval rate: I. Clarify Product Classification to Avoid Misclassification Classification Basis: Accurately determine the management category (Class I, II, or III) based on the “Medical Device Classification Rules,” considering dimensions such as product intended use, structural features, and form of use. Class I: Subject to filing management, with no requirement for clinical trials. Classes II and III: Require registration application. Class III and certain high-risk Class II products typically necessitate clinical trial support. Common Pitfalls: Misclassifying Class II products as Class I, leading to non-compliance in subsequent document submissions. Solutions: Strengthen scientific analysis of product functions, mechanisms of action, and risk levels. Seek consultation from professional institutions or regulatory authorities when necessary, utilizing the latest regulations and guidance documents to ...
- Source: drugdu
- 100
- October 15, 2025
【EXPERT Q&A】What processes do medical devices need to go through before they can be produced?

Drugdu.com expert’s response: Key Processes for Medical Devices from R&D to Production Medical devices must undergo several critical processes, including infrastructure establishment, quality management system (QMS) development, product design and development, registration testing, clinical evaluation, product registration application, on-site QMS verification, production license application, and market launch. The specifics are as follows: Infrastructure Establishment Business Registration: Determine the business scope based on corporate development plans and product positioning, then complete registration under the current registered capital subscription system and the “three-in-one” registration system (merging business licenses, organization code certificates, and tax registration certificates). Hardware Preparation: Construct facilities compliant with the Medical Device Production Quality Management Standardsaccording to the category and process requirements of the intended medical devices. If the product requires a sterile environment, a qualified cleanroom must be built. Additionally, acquire production equipment and inspection instruments necessary for manufacturing and testing. If a company faces challenges in hardware investment or ...
- Source: drugdu
- 171
- October 13, 2025
【EXPERT Q&A】How to inquire about pharmaceutical manufacturing enterprises and their production qualifications?

Drugdu.com expert’s response: You can obtain detailed information through the following authoritative channels: I. National Medical Products Administration (NMPA) Official Website Access Path: Visit the NMPA official website, click on “Drugs” under the navigation menu, and select “Data Query.” Choose “Pharmaceutical Manufacturers” or “Drug Production License.” Query Methods: Enter keywords such as enterprise name, license number, or unified social credit code. Supports exact or fuzzy searches. Search results include basic enterprise information (e.g., registered address, legal representative), production scope, license number, and validity period. Classification Code Explanation: Uppercase Letters: Categorize drug marketing authorization holders and product types (e.g., “A” for self-production, “B” for contracted production). Lowercase Letters: Distinguish preparation attributes (e.g., “h” for chemical drugs, “z” for traditional Chinese medicines). Usage: Combine codes to filter target enterprises (e.g., to query Beijing-based manufacturers of “granules,” select province as “Beijing,” classification code “A,” and dosage form “granules”). II. Provincial Drug Regulatory Authority Websites ...
- Source: drugdu
- 99
- October 10, 2025
【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
- 107
- 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
- 157
- 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
- 119
- 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
- 93
- October 1, 2025

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