Expert Q&A – Page 6 – media

【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
- 182
- 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
- 181
- 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
- 223
- 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
- 174
- August 6, 2025
【EXPERT Q&A】What are the main contents of compliance review for enterprises?

Drugdu.com expert’s response: Conducting compliance reviews is a critical step for enterprises to ensure their operations align with laws, regulations, industry standards, and internal rules and regulations. Its primary aim is to mitigate legal risks, safeguard corporate reputation, and promote sustainable development. The main areas covered by compliance reviews include laws and regulations, industry norms, internal systems, data protection and privacy, supply chain management, financial and tax compliance, labor and employment practices, environmental protection, anti-corruption and business ethics, and international trade compliance, among others. Here are the specifics: I. Compliance Review of Laws and Regulations National Laws and Regulations: Examine whether the enterprise’s business operations comply with national laws, administrative regulations, local ordinances, and other requirements, such as the Company Law, Contract Law, Labor Law, and Environmental Protection Law. Industry Regulatory Requirements: For specific industries (e.g., finance, healthcare, food, and pharmaceuticals), review compliance with special regulations set by industry regulatory bodies, such as capital ...
- Source: drugdu
- 172
- August 4, 2025
【EXPERT Q&A】What is the current outlook for drug registration?

Drugdu.com expert’s response: The overall prospects for drug registration are positive, driven by factors such as policy support, market demand, improved review efficiency, accelerated internationalization, and innovation-driven development. The industry is rapidly advancing toward high-quality, high-efficiency, and internationalized growth. However, it also faces challenges such as R&D investment, market competition, and regulatory changes. Below is a detailed analysis: I. Dual Drivers of Policy Support and Market Demand Policy Support: The National Medical Products Administration (NMPA) has approved 35% more new drugs through the priority review pathway year-on-year, with anti-tumor drugs accounting for 41%. This policy orientation has significantly accelerated the approval process for innovative drugs, creating a favorable policy environment for drug registration. Market Demand: With an aging population and escalating health needs, the pharmaceutical market continues to expand. By 2025, China’s pharmaceutical market size will exceed RMB 1.6 trillion, representing an 8% year-on-year increase, providing vast market space for ...
- Source: drugdu
- 139
- August 1, 2025
【EXPERT Q&A】How effective is the treatment with Masidopeptide?

Drugdu.com expert’s response: Mazdutide has demonstrated significant efficacy in weight reduction, glycemic control, and comprehensive metabolic improvement, along with favorable safety and tolerability profiles. The specific therapeutic effects are as follows: I. Weight Reduction Phase III Clinical Trial Data: In the pivotal Phase III GLORY-1 trial, after 48 weeks of treatment, the 4mg mazdutide group achieved an average weight reduction of 11.0%, while the 6mg group reached an impressive 14.0%, significantly outperforming the placebo group (0.3%). Notably, 66.7% of patients in the 6mg group lost over 10% of their body weight, and nearly half (49.5%) lost more than 15%. Real-World Cases: One patient using 6mg of mazdutide for 24 weeks saw their weight drop from 92kg to 78kg, with a 12cm reduction in waist circumference. Another female patient with a BMI of 32 experienced a weight reduction from 92kg to 76.8kg and a 12cm decrease in waist circumference after 48 ...
- Source: drugdu
- 120
- July 30, 2025
【EXPERT Q&A】Under the background of volume-based procurement, how to select high cost-performance generic drug research and development varieties?

Drugdu.com expert’s response: In the context of volume-based procurement, selecting high-cost-effectiveness generic drug R&D targets requires a comprehensive evaluation across five dimensions: market potential, competitive landscape, technical feasibility, policy orientation, and corporate resources. Priority should be given to品种 (products) that have passed consistency evaluations, address rigid clinical needs, possess moderate technical barriers, and are supported by policies. Below are detailed strategies and analyses: I. Market Potential: Focus on High-Sales, High-Profit, High-Growth Areas Absolute Sales Data Prioritize large-scale products with annual sales exceeding RMB 1 billion, such as antihypertensive drug amlodipine and antidiabetic drug metformin. Even with a 50% price reduction post-procurement, these products can maintain profitability through increased sales volume. Case Study: In the “4+7” volume-based procurement, Beijing Jialin Pharmaceutical won the bid for atorvastatin calcium at RMB 6.6 per box, achieving a gross margin exceeding 100%. With procurement across just 11 cities, projected profits reached RMB 100 million, with even ...
- Source: drugdu
- 234
- July 28, 2025
【EXPERT Q&A】What contents need to be submitted for the registration application of domestic Class II medical devices?

Drugdu.com expert’s response: The registration of Class II medical devices in China requires submission of key documents covering risk analysis, technical specifications, testing reports, clinical evaluation, labeling, quality management systems, and authenticity declarations. Detailed requirements are outlined below: I. Foundational Qualification Documents Medical Device Registration Application Form: Must include core details such as product name, model/specification, structural composition, and intended use, signed and stamped by the legal representative or responsible person. Enterprise Qualification Proof: Copy of the business license (valid within its term). Medical Device Manufacturing License (if applicable; the registered product must fall within the approved scope). Personnel Qualification Proof: Identity, educational, or professional title certificates for the legal representative, enterprise leader, and quality manager (the latter must have a medical device-related background). II. Product Technical Documentation Product Technical Report: Covers design principles, structural composition, manufacturing materials, performance indicators, and production processes. Must provide the product technical requirement number and explain the basis for key ...
- Source: drugdu
- 129
- July 25, 2025
【EXPERT Q&A】How should the clinical evaluation path for Class II active medical devices be selected?

Drugdu.com expert’s response: The selection of clinical evaluation pathways for Class II active medical devices should be based on product risk levels, technical characteristics, and data availability, with evaluations completed through three pathways: exemption from clinical trials, comparison with predicate devices, or clinical trials. The specific analysis is as follows: I. Core Pathway Selection Criteria Exemption from Clinical Trials Pathway Applicable Conditions: The product is listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation and fully aligns with the descriptions in the catalogue. Key Operational Points: Submit comparative data between the product and the catalogue entries, along with a comparison statement with legally marketed medical devices already approved in China (covering fundamental principles, structural composition, performance requirements, etc.) to demonstrate equivalence. Typical Examples: Low- to moderate-risk products such as general surgical instruments and certain rehabilitation aids. Comparison with Predicate Devices Pathway Applicable Conditions: The product is essentially equivalent to a legally ...
- Source: drugdu
- 184
- July 23, 2025

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