Expert Q&A – Page 5 – media

【EXPERT Q&A】How to handle the filing for Class I medical device products?

Drugdu.com expert’s response: Medical Device Class I Product Filing Process I. Pre-Filing Preparation Confirm Product Classification Ensure the product falls within the scope of the Class I Medical Device Product Catalog or the In Vitro Diagnostic Reagent Classification Sub-Catalog. If the product is outside these catalogs, apply to the National Medical Products Administration (NMPA) for classification determination. Filing can proceed only after confirmation as a Class I medical device. Prepare Filing Documents The following core materials must be submitted (subject to local regulatory requirements): Filing Form: Completed and stamped with the enterprise’s official seal or signed by the legal representative. Enterprise Qualification Documents: Business license duplicate. Legal representative’s identification. Product Technical Documents: Product Technical Requirements (prepared per the Guidelines for Drafting Technical Requirements for Medical Devices), specifying functional and safety indicators, as well as testing methods. Product Inspection Report (self-tested or commissioned testing, including product information, testing basis, and results). Instructions for Use and Label Samples (compliant ...
- Source: drugdu
- 186
- August 27, 2025
【EXPERT Q&A】Are quality management systems in the medical device industry effective?

Drugdu.com expert’s response: The quality management system (QMS) in the medical device industry is not only valuable but also a core element in ensuring product safety and effectiveness, meeting regulatory requirements, enhancing corporate competitiveness, and promoting the healthy development of the industry. Its importance is reflected in the following aspects: Ensuring Patient Safety and Product Effectiveness Risk Control: Medical devices directly interact with the human body, and quality defects can lead to severe health risks (e.g., surgical instrument fractures, implant failures, diagnostic device misdiagnoses). The QMS reduces risks to acceptable levels through systematic risk assessments (e.g., Failure Mode and Effects Analysis, or FMEA), design controls, and production process monitoring. Performance Verification: Rigorous testing and validation (e.g., biocompatibility testing, electrical safety testing, performance stability testing) ensure that products meet their intended purposes and prevent medical accidents caused by functional failures. Meeting Global Regulatory and Compliance Requirements International Standard Mandates: Major global ...
- Source: drugdu
- 173
- August 25, 2025
【EXPERT Q&A】What are the registration and regulatory requirements that IVD test reagents for Chikungunya virus need to comply with?

Drugdu.com expert’s response: The registration and regulatory requirements for IVD test reagents for Chikungunya virus vary across different countries and regions. Below are the specific requirements for some major countries and regions: European Union Regulatory Compliance: Must comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Product Classification: According to the classification rules of the IVDR, IVD test reagents for Chikungunya virus are typically classified as Class C or Class D, depending on their intended use and risk level. Review and Certification: For Class C or Class D products, review and certification by a Notified Body are required. Quality Management System: Companies must establish a quality management system that complies with the ISO 13485 standard and ensure that the product meets relevant basic requirements. Submission of Technical Documentation: Technical documentation, including product performance evaluation reports, clinical evidence, labels, and instructions, must be submitted. CE Marking and ...
- Source: drugdu
- 211
- August 22, 2025
【EXPERT Q&A】Why are glucocorticoids (such as prednisone and deflazacort) the standard therapeutic drugs for Duchenne Muscular Dystrophy (DMD)?

Drugdu.com expert’s response: Glucocorticoids (such as prednisone and deflazacort) are the standard therapeutic drugs for Duchenne muscular dystrophy (DMD), primarily due to their well-established efficacy in delaying disease progression, improving motor function, and prolonging survival. Their mechanisms of action also align closely with the pathological features of DMD. Below is a detailed analysis of the reasons: The only disease-modifying drugs validated by evidence-based medicine Prolonged motor capacity: Multiple studies have demonstrated that glucocorticoids significantly delay the decline in motor function in DMD patients. For example: Children treated with prednisone exhibit superior muscle strength compared to untreated counterparts, with independent walking duration extended by over three years. Deflazacort treatment delays the age at which children lose ambulation by 1.4-2.5 years, increases the 6-minute walk distance, and improves pulmonary function. Delayed complications: Glucocorticoids reduce the risk of scoliosis (11.6% in the treatment group vs. 33.2% in the untreated group), postpone the onset ...
- Source: drugdu
- 201
- August 20, 2025
【EXPERT Q&A】How can one query the natural medicines approved in the past decade and their sources through the FDA drug approval database?

Drugdu.com expert’s response: To query FDA-approved natural drugs and their sources over the past decade through the FDA drug approval databases, the following systematic workflow can be followed, integrating FDA official resources with natural product classification logic for efficient retrieval: I. Define Search Objectives and Natural Drug Categories Natural drugs typically refer to active ingredients directly derived from plants, microorganisms, marine organisms, or minerals, as well as their structurally modified derivatives. Key focus areas include: Plant-derived: Examples include paclitaxel (from Pacific yew) and artemisinin (from sweet wormwood). Microorganism-derived: Examples include erythromycin (from actinomycetes) and cyclosporine (from fungi). Marine-derived: Examples include trabectedin (from sea squirts) and eribulin (from sponges). II. Leverage FDA Core Databases for Screening Drugs@FDA Database Steps: Access the database and select “Advanced Search”. Set the “Approval Date Range” to the past decade (e.g., January 1, 2015, to December 31, 2025). Enter natural product-related keywords in the “Active Ingredient” ...
- Source: drugdu
- 160
- August 18, 2025
【EXPERT Q&A】What does the release of the management regulations for the filing of Internet drugs and medical devices mean?

Drugdu.com expert’s response: The issuance of the Administrative Provisions on the Filing of Internet Information Services for Drugs and Medical Devices marks a new phase in China’s regulatory efforts to standardize and strengthen oversight of internet-based information services for drugs and medical devices. Its core significance is reflected in the following aspects: I. Regulatory Framework Upgrade: Decentralized Management Enhances Efficiency Clarified Division of Responsibilities National Medical Products Administration (NMPA): Oversees nationwide filing guidance and supervision, establishing unified standards. Provincial Medical Products Regulatory Authorities: Responsible for specific filings and local supervision, creating a “national coordination + local implementation” model that ensures policy consistency while enhancing regional regulatory flexibility. Refined Filing Units: Filings are conducted on a per-website or per-app basis to ensure traceability of information on each platform and prevent regulatory gaps caused by “one license for multiple uses.” Strengthened Dynamic Oversight Real-Time Updates for Filing Changes: Key information, such as the host ...
- Source: drugdu
- 209
- August 15, 2025
【EXPERT Q&A】What are the key points for the inspection of active medical devices?

Drugdu.com expert’s response: The inspection of active medical devices should focus on their safety, effectiveness, and compliance, requiring a systematic evaluation that integrates product characteristics, usage scenarios, and regulatory requirements. Below are the core inspection points: I. Electrical Safety and Protection Insulation Performance Test the insulation resistance between live parts and accessible components to ensure effective current isolation under both normal and fault conditions, preventing electric shock. Verify the durability of insulating materials under high-temperature and humid conditions to avoid insulation failure due to aging. Leakage Current Control Detect current flowing from live parts to non-live parts (e.g., housing) during operation, ensuring it remains below the human safety threshold (typically ≤0.5mA). Simulate single-point failures (e.g., insulation damage) to verify that the protective grounding system can safely divert leakage current to the ground. Voltage Withstand Capability Apply a test voltage higher than the rated voltage (e.g., 1.5 times the operating voltage) ...
- Source: drugdu
- 177
- August 13, 2025
【EXPERT Q&A】What is the function of plasmid transfection reagents?

Drugdu.com expert’s response: Plasmid transfection reagents are core tools in molecular biology and gene engineering experiments, designed to efficiently deliver exogenous plasmid DNA into eukaryotic cells. Their functions span the entire process from cellular uptake to gene expression, as detailed below: I. Overcoming the cell membrane barrier to facilitate DNA transmembrane transport The phospholipid bilayer structure of the cell membrane inherently blocks large DNA molecules. Transfection reagents overcome this obstacle through physical or chemical mechanisms: Charge neutralization and complex formation: Plasmid DNA carries a negative charge, while transfection reagents (e.g., cationic liposomes, polyethyleneimine/PEI) are positively charged. They form stable nanoscale complexes via electrostatic interactions, neutralizing DNA’s negative charge and reducing electrostatic repulsion with the cell membrane, enabling cellular uptake through endocytosis. Membrane fusion or pore formation: Liposome-based reagents can fuse with the cell membrane, creating temporary channels for direct DNA release into the cytoplasm. Polymer-based reagents (e.g., PEI) may induce ...
- Source: drugdu
- 176
- August 11, 2025
【EXPERT Q&A】What precautions should be taken when conducting tests on the influencing factors of drug stability?

Drugdu.com expert’s response: The drug stability influencing factors test is a critical study that evaluates the quality changes of drugs under specific environmental conditions, aiming to provide a scientific basis for drug formulation design, packaging selection, storage condition determination, and expiry date setting. Its core considerations cover various aspects, including test design, condition control, sample management, testing and analysis, as well as data recording and reporting, as detailed below: I. Test Design Phase Clarify Test Objectives: Distinguish between influencing factors tests (e.g., high temperature, high humidity, intense light) and long-term stability tests or accelerated tests, clarifying the focus of each test (e.g., rapid screening of degradation pathways vs. prediction of long-term stability). Design targeted test protocols based on drug characteristics (e.g., chemical structure, dosage form, pH sensitivity). Select Representative Samples: Use samples (including both active pharmaceutical ingredients and formulations) that are consistent with actual production batch processes, avoiding laboratory-scale pilot samples. Ensure that sample ...
- Source: drugdu
- 217
- August 8, 2025
【EXPERT Q&A】Why is it essential to implement the Unique Device Identification (UDI) system for medical devices?

Drugdu.com expert’s response: The Unique Device Identification (UDI) for medical devices serves as their “digital ID card,” and its application is a core tool for enhancing industry management efficiency and safeguarding public safety in medical device usage. The specific reasons are as follows: I. Full Lifecycle Traceability: Precise Problem Identification and Risk Reduction 1. Rapid Recall of Problematic Devices: UDI connects the entire chain of production, distribution, and usage through a unique code, enabling the localization of problematic batches or individual devices within hours. For instance, the U.S. Food and Drug Administration (FDA) completed a global recall of faulty heart stents in two days using UDI, a process that traditionally took weeks, significantly reducing patient risks. 2. Adverse Event Monitoring and Analysis: By linking UDI with patient data, the usage effectiveness of devices can be tracked, and correlations between adverse reactions and specific models or batches can be analyzed, providing data-driven support ...
- Source: drugdu
- 167
- August 6, 2025

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