Expert Q&A – media

【EXPERT Q&A】When conducting clinical trials with in vitro diagnostic reagents, do the supporting instruments need to obtain certificates

Drugdu.com expert’s response: Whether supporting instruments require prior certification when in vitro diagnostic (IVD) reagents undergo clinical trials necessitates a case-by-case analysis, as detailed below: I. Supporting Instruments Already Marketed and Certified If the supporting instrument is a product already on the market and has obtained relevant certifications (e.g., medical device registration certificate), it can be directly used in clinical trials. In this case, the following must be ensured: Complete Instrument Qualifications: Provide the instrument’s production license, quality management system certificate, product inspection report, and other documents to demonstrate compliance with regulatory requirements. Sufficient Performance Verification: Clearly specify the model, specifications, and compatibility with the reagent of the supporting instrument in the clinical trial protocol, and verify its detection performance (e.g., accuracy, precision) through pre-trials. Comprehensive Usage Records: Document the receipt, storage, distribution, usage, and maintenance of the instrument to ensure traceability throughout the trial process. II. Supporting Instruments as ...
- Source: drugdu
- 35
- March 9, 2026
【EXPERT Q&A】Why is it so difficult to obtain the qualifications for Class II and Class III medical devices?

Drugdu.com expert’s response: The difficulty in obtaining qualifications for Class II and III medical devices lies in high product risks, strict supervision, complex procedures, high professional thresholds, large investment, long cycles, and enterprises often being rejected repeatedly due to insufficient compliance capabilities, non-standard materials, or non-compliance with requirements for premises, personnel, and systems. I. Root Cause: Supervision Intensity Determined by Risk Level Class II (medium risk) e.g., blood glucose meters, electrocardiographs, surgical masks. They contact the human body or carry certain injury risks, requiring registration/filing + strict system management. Class III (high risk) e.g., cardiac stents, artificial joints, ventilators, in vitro diagnostic reagents. Directly related to life safety, requiring strict approval, mandatory clinical trials, and full-chain supervision. II. Process & Approval Difficulty 1. Registration (Most Difficult) Class II: Approved by provincial medical products administrations. Requires product testing + clinical evaluation (some exempt) + system ...
- Source: drugdu
- 45
- March 6, 2026
【EXPERT Q&A】Can multiple manufacturing enterprises be entrusted to produce medical devices?

Drugdu.com expert’s response: Chinese Current Regulations Have Lifted the “Only One Contract Manufacturer” Restriction Medical device registrants/filers may entrust multiple qualified enterprises to manufacture products. I. Regulatory Basis Regulation on the Supervision and Administration of Medical Devices (Order No. 739) Registrants/filers may entrust qualified enterprises to manufacture medical devices; no limit on the number of contract manufacturers. Measures for the Supervision and Administration of Medical Device Production It explicitly allows registrants to entrust multiple manufacturers. A quality and risk capability assessment shall be conducted for each entrusted enterprise; a delegation agreement + quality agreement shall be signed and supervision shall be implemented. NMPA Announcement No. 38 of 2024 Supports multiple entrustment and requires the registration certificate to list all entrusted manufacturers. II. Two Common Models 1. Multiple Entrustment for Finished Products (Multi‑source Supply) Entrust the same finished product to multiple manufacturers to expand ...
- Source: drugdu
- 44
- March 4, 2026
API Is Not Just a Cost – It’s Your Ticket to Global Markets

How serious buyers actually screen suppliers For professional buyers, a complete COA and a clear GMP certificate set often carry more weight than the numbers on a quotation sheet. In many export projects, Active Pharmaceutical Ingredients (APIs) are still treated as “standard items”: available stock, basic documents, acceptable price – and the box is ticked. However, Drugdu.com’s trade data show a clear divide: suppliers that consistently receive high-quality inquiries and progress into registration and tender stages are the ones that treat APIs as the first piece of the supply chain, not just a cost element. When global buyers evaluate a new project, this is usually where they start. 01. Why is the API the “first piece”? The API is the source of pharmacological activity, but its role in regulatory and commercial decision-making is much broader. Each API comes with a full “identity profile”: CAS number, molecular structure, purity, impurity profile, ...
- Source: drugdu
- 50
- March 3, 2026
【EXPERT Q&A】What factors should be given priority consideration in the benefit-risk assessment of medical devices?

Drugdu.com expert’s response: The benefit-risk assessment of medical devices is a core aspect of ensuring their safety and effectiveness, requiring systematic analysis based on scientific evidence and regulatory requirements. Below are the key considerations and detailed explanations: I. Core Evaluation Dimensions 1. Benefit Factors Clinical Efficacy Disease diagnostic accuracy (e.g., sensitivity, specificity). Therapeutic effectiveness (e.g., cure rates, symptom relief rates). Contribution to public health (e.g., infectious disease screening, epidemic prevention and control). Patient Benefits Improved quality of life (e.g., pain reduction, restored mobility). Extended survival (e.g., early cancer diagnostic devices). Reduced complications or need for secondary interventions (e.g., minimally invasive surgical instruments). Social Value Optimized healthcare resources (e.g., rapid diagnostic devices shortening diagnosis time). Promotion of healthcare equity (e.g., low-cost basic diagnostic tools). 2. Risk Factors Device-Related Risks Design flaws: e.g., allergic reactions due to poor material biocompatibility. Performance instability: e.g., low reproducibility of results from diagnostic devices. Operational complexity: ...
- Source: drugdu
- 46
- March 2, 2026
【EXPERT Q&A】How can the compliance assessment of in vitro diagnostics (IVDR) in the European Union be carried out in a standardized and efficient manner?

Drugdu.com expert’s response: I. Preliminary Preparation: Clarify Classification and Regulatory Foundations 1. Product Classification According to Annex VIII of the IVDR Regulation (EU 2017/746), in vitro diagnostic devices are categorized into four risk classes: A, B, C, and D: Class A: Low risk (e.g., general laboratory reagents). Non-sterile Class A devices can be self-declared, while sterile Class A devices require notified body involvement. Class B: Medium-low risk (e.g., pregnancy test kits). Requires notified body review of technical documentation and quality management system (QMS). Class C: Medium-high risk (e.g., tumor marker tests). Requires comprehensive notified body review. Class D: High risk (e.g., HIV or HCV tests). Subject to the strictest review, including performance evaluation and clinical data. 2. Regulations and Standards Core Regulation: IVDR (EU 2017/746) and its accompanying guidelines. Harmonized Standards: ISO 13485 (QMS), ISO 14971 (risk management). Unique Device Identification (UDI): Must be registered in the EUDAMED database and ...
- Source: drugdu
- 56
- February 27, 2026
【EXPERT Q&A】How to apply for the classification and definition of medical devices?

Drugdu.com expert’s response: To ensure the authenticity and completeness of application materials, the following procedures and requirements must be followed when applying for classification determination of medical devices: I. Application Methods and Channels 1. Online Registration and Application Visit the official website of the National Institutes for Food and Drug Control (NIFDC, under the National Medical Products Administration) at https://www.nifdc.org.cn. Navigate to the “Medical Device Standards and Classification Management” section and click on the “Medical Device Classification Determination Information System.” Register an account, complete the Application Form for Classification Determination of Medical Devices, and upload other required materials. Starting from February 19, 2024, paper submissions are no longer required; the entire process is conducted electronically. 2. Paper Submission (Backup Option) If paper materials are required, print the Application Form for Classification Determination online, affix the enterprise’s paging seal to all documents, and mail them to the following addresses based on product type: Domestic Products: ...
- Source: drugdu
- 49
- February 25, 2026
【EXPERT Q&A】The US FDA has implemented a brand-new QMSR system regulation for medical devices. What significant changes will occur in the corresponding on-site inspections?

Drugdu.com expert’s response: The U.S. FDA’s new Quality Management System Regulation (QMSR) for medical devices marks a significant transformation in its regulatory framework and inspection logic. By integrating the ISO 13485:2016 international standard, QMSR drives a shift in quality management from “clause compliance” to “risk-driven” approaches, while strengthening lifecycle-wide compliance controls. Against this backdrop, FDA on-site inspections will undergo the following key changes: I. Evolution of Inspection Basis and Process 1. Regulatory Restructuring: QMSR incorporates ISO 13485:2016 in its entirety through “reference incorporation,” while retaining FDA-specific requirements (e.g., record retention language, certain reporting obligations). Inspections will be conducted based on “ISO 13485:2016 clauses + FDA additional requirements,” rather than the standalone clauses of the previous QSR. 2. Updated Inspection Manual: The FDA has abolished the long-standing Quality System Inspection Technique (QSIT) methodology and introduced the new Medical Device Manufacturer Inspection Compliance Program Manual (7382.850). This manual categorizes QMSR requirements into six quality ...
- Source: drugdu
- 62
- February 23, 2026
【EXPERT Q&A】How is a drug safety evaluation experiment conducted?

Drugdu.com expert’s response: Drug safety evaluation experiments require a systematic process that combines in vitro experiments, animal experiments, and clinical studies to comprehensively assess potential drug risks and ensure medication safety. Below are the specific experimental methods and procedures: I. Foundations of Experimental Design Research Objectives and Plan Clarify the drug’s intended use, target population, and core objectives (e.g., toxicity assessment, dose exploration). Develop a detailed protocol, including experimental design, animal species/quantity, and dosing duration. Conduct literature reviews to understand safety data for similar drugs and identify potential risk points. Selection of Experimental Models Animal Models: Choose mice, rats, dogs, or non-human primates based on drug characteristics. In Vitro Models: Utilize cell cultures, tissue chips, or computational simulations (e.g., PBPK models) to predict toxicity. Special Population Models: Design targeted experiments for children, pregnant women, etc. II. Core Experimental Methods 1. Acute Toxicity Experiments Objective: Evaluate toxic reactions following single or ...
- Source: drugdu
- 58
- February 20, 2026
【EXPERT Q&A】How should we view the consistency between generic drugs and original research drugs?

Drugdu.com expert’s response: The consistency between generic drugs and originator drugs is a crucial issue in the pharmaceutical field, with its core lying in assessing whether generic drugs achieve equivalent levels in terms of quality, efficacy, and safety compared to originator drugs. This issue not only concerns patients’ rights to medication but also affects the balance between innovation and accessibility in the pharmaceutical industry. The following analysis unfolds from four dimensions: science, policy, economy, and society. I. Scientific Foundation: Technical Standards for Consistency Evaluation Pharmaceutical Equivalence：Generic drugs must be identical to originator drugs in terms of active ingredients, dosage forms, strengths, and routes of administration, and demonstrate consistency in physical and chemical properties through tests such as dissolution rate and content uniformity. This serves as the fundamental threshold for generic drug development. Bioequivalence (BE)：It is necessary to prove through human clinical trials or alternative methods (e.g., in vitro models) that ...
- Source: drugdu
- 76
- February 18, 2026

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