Expert Q&A – Page 2 – media

【EXPERT Q&A】How to apply for a medical device production license?

Drugdu.com expert’s response: To apply for a Medical Device Manufacturing License, enterprises need to follow a systematic process that covers material preparation, review stages, and key compliance points, as outlined below: Pre-Application Core Condition Self-Check Qualification Foundations Medical Device Registration: Possession of a valid Medical Device Registration Certificate and product technical requirement documents for the intended medical device production. Business License Scope: The business license must explicitly include medical device manufacturing within its scope of operations. Production Conditions Facilities: Adequate production facilities matching the scale of operations, including cleanrooms (compliant with ISO 14644 standards for sterile medical devices) and storage areas. Provide property ownership certificates or lease agreements. Equipment: Equipped with primary production equipment (e.g., injection molding machines, sterilization equipment) and inspection instruments (e.g., microbiological testers, mechanical testers). A detailed equipment list should be provided. Personnel: Production, quality, and technical leaders must possess relevant professional qualifications (e.g., degrees in biomedical ...
- Source: drugdu
- 75
- November 10, 2025
【EXPERT Q&A】Which laws, regulations and system standards must medical devices comply with?

Drugdu.com expert’s response: The medical device industry is subject to a multi-tiered regulatory framework of laws and regulations and standards at both domestic and international levels, covering the entire product lifecycle management. The following provides an explanation from four perspectives: legal framework, international standards, domestic regulations, and key compliance considerations. I. Legal Framework: Global and Regional Core Regulations China’s Regulations on the Supervision and Administration of Medical Devices Core Positioning: The “basic law” for medical device supervision, clarifying classification management, registration/filing, production/operation/usage requirements, and legal liabilities. Key Provisions: Classification Rules: Products are categorized into Class I, II, and III based on risk levels, with differentiated regulatory oversight (e.g., stringent approval for Class III). Registration and Filing: Class I devices undergo filing management, while Class II and III devices require technical evaluation and system verification, along with submission of clinical evaluation data (some Class II devices may be exempted). Unique Device Identification ...
- Source: drugdu
- 129
- November 7, 2025
【EXPERT Q&A】What requirements does the FDA have for the unique identification (UDI) of medical combination products?

Drugdu.com expert’s response: I. Which combination products does the FDA regulate? First, clarify the scope The FDA’s UDI rules primarily target medical device components, but combination products (such as drug – device combinations or device – drug co – packaged products) need to be treated differently based on their types. In simple terms: If the device is the main function in a combination product (for example, a drug – eluting stent, where the core is the stent): It must be labeled with a UDI, and the drug’s NDC code cannot be used as a substitute. If the drug is the main function (for example, a prefilled syringe, where the core is the drug inside): If it has already been labeled with an NDC code, the device part does not need to be additionally labeled with a UDI (but if the device components are sold separately, they still need to be ...
- Source: drugdu
- 137
- November 5, 2025
【EXPERT Q&A】Why do Class II and Class III medical devices need to be registered?

Drugdu.com expert’s response: Class II and Class III medical devices require registration, primarily for the following reasons: I. Regulatory Requirements The Regulations on the Supervision and Administration of Medical Devices explicitly stipulate that Class II and Class III medical devices must undergo registration management. Medical devices that have not been registered are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, which enterprises must adhere to in order to ensure lawful business operations. II. Risk Control Class II medical devices carry moderate risks: Examples include thermometers, sphygmomanometers, and electrocardiographs. If there are issues with the product quality or safety, it may lead to misdiagnosis, mistreatment, or certain harm to the patient’s body. Class III medical devices pose higher risks: These include devices such as cardiac pacemakers, artificial joints, and implantable cardiac stents. These products are typically used to ...
- Source: drugdu
- 83
- October 29, 2025
【EXPERT Q&A】What is the Unique Device Identifier (UDI) for medical devices?

Drugdu.com expert’s response: The Unique Device Identifier (UDI) is a core tool in the international regulatory landscape for medical devices, designed to enable precise traceability and management throughout the entire lifecycle of medical devices via standardized coding. Its core components, implementation logic, and value are outlined below: I. UDI Composition: Dual-Code Synergy for Precise Identification The UDI consists of two parts—the Device Identifier (DI) and the Production Identifier (PI)—forming a “static + dynamic” dual-recognition system: Device Identifier (DI): Serves as the foundational identity code for medical devices, encompassing registrant/filing entity information, model specifications, and packaging hierarchy. For example, the DI of a specific brand of cardiac stent uniquely identifies its manufacturer, product model, and packaging format (e.g., single unit or boxed). The DI remains stable once assigned, ensuring traceability of basic product information. Production Identifier (PI): Acts as the dynamic information code for medical devices, covering production batch numbers, serial numbers, manufacturing ...
- Source: drugdu
- 145
- October 27, 2025
【EXPERT Q&A】Is it mandatory to have a stability test protocol and report for stress testing during the pharmaceutical R&D process?

Drugdu.com expert’s response Yes, stability test protocols and reports are mandatory for stress testing in the pharmaceutical R&D process. The reasons are as follows: I. Regulatory Requirements Consistency in International and Domestic Regulations: Whether it is China’s NMPA, the U.S. FDA, or the international ICH guidelines, all explicitly mandate that stress testing must be conducted for active pharmaceutical ingredients (APIs), accompanied by comprehensive stability test protocols and reports. These documents are essential prerequisites for drug marketing authorization, and their absence will directly result in application rejection. Essential Materials for Marketing Authorization: Stability test protocols and reports constitute core documentation for drug registration submissions. Regulatory authorities review these files to assess the quality controllability and safety of pharmaceutical products. II. Logical Imperatives in R&D Guiding Subsequent R&D Stages: Stability test protocols meticulously document critical information such as test methods, conditions, and sampling points, providing a foundation for subsequent accelerated and long-term ...
- Source: drugdu
- 137
- October 24, 2025
【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
- 148
- 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
- 156
- 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
- 143
- 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
- 93
- October 15, 2025

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