Expert Q&A – media

【EXPERT Q&A】How can the safety of subjects be guaranteed in drug clinical trials?

Drugdu.com expert’s response: Drug clinical trials are a critical step in evaluating the safety and efficacy of new drugs, with ensuring the safety of trial participants being the foremost principle. To safeguard participant safety, drug clinical trials have established a comprehensive safety assurance system through stringent regulatory oversight, scientifically rigorous design, thorough risk assessment and management, multi-layered protective measures, and continuous ethical review and supervision. The following elaborates on these aspects in detail: 1. Stringent Regulatory and Ethical Requirements Adherence to International Norms: Drug clinical trials must comply with internationally recognized ethical guidelines, such as the Declaration of Helsinki and the Belmont Report, which emphasize principles such as participant protection, informed consent, and risk minimization. Compliance with Domestic Regulations: In China, drug clinical trials must adhere to relevant laws and regulations, including the Good Clinical Practice (GCP) guidelines and the Drug Administration Law. These regulations impose explicit requirements on all ...
- Source: drugdu
- 41
- February 13, 2026
【EXPERT Q&A】What important regulations and requirements should be mastered for the medical device equivalence certificate of the EU MDRCE?

Drugdu.com expert’s response: Under the framework of the EU Medical Device Regulation (MDR), the demonstration of equivalence for medical devices is a crucial step in assessing the similarity between a new product and a marketed product in terms of technical, biological, and clinical characteristics. This directly determines whether the new product can enter the EU market in compliance with regulations. Below are the key provisions and requirements that need to be mastered for demonstrating equivalence: I. Technical Characteristics Requirements Similar Usage Conditions: The device under evaluation and the presumed equivalent device must be used under similar conditions, meaning there should be no significant clinical differences in their safety and clinical performance. This implies that in real-world medical scenarios, both devices should exhibit similar levels of patient protection and stability in treatment outcomes. Similar Software Algorithms: For medical devices incorporating software algorithms, the functional principles, clinical performance, and intended purposes of ...
- Source: drugdu
- 38
- February 11, 2026
【EXPERT Q&A】What are the registration and regulatory (market access) requirements for Nipah virus IVD in vitro diagnostic test reagents in India, the European Union, and the WHO?

Drugdu.com expert’s response: I. Indian Registration and Regulatory Requirements Regulatory Framework: The Indian Drugs and Cosmetics Act and related regulations (such as CDSCO guidelines) serve as the primary regulatory basis for IVD products. Classification Management: Nipah virus detection reagents are typically classified as high-risk categories and are subject to rigorous review. Technical Documentation Requirements: Complete technical documentation must be submitted, including product descriptions, performance indicators, test reports, production processes, and quality management system documents. Key information such as detection principles, targets (genes/antigens/antibodies), sample types, and batch release criteria must be provided. Clinical Trial Requirements: Clinical trials may be required, and corresponding clinical trial data must be submitted to verify the clinical performance and effectiveness of the product. Quality Management System: A quality management system compliant with ISO 13485 standards must be established, and relevant certification certificates must be submitted. Import and Sales License: Import and sales approval must be obtained from the ...
- Source: drugdu
- 46
- February 9, 2026
【EXPERT Q&A】Can the registration and access of medical device products in Brazil be accelerated if they already have FDA and CE certifications?

Drugdu.com expert’s response: Medical devices that have obtained FDA and CE certifications can expedite registration and market access in Brazil, primarily reflected in simplified review processes, reduced redundant testing, and shortened approval cycles. The specific acceleration mechanisms and operational points are as follows: I. Acceleration Mechanisms: ANVISA’s Recognition of International Certifications The Brazilian National Health Surveillance Agency (ANVISA) explicitly allows referencing international authoritative certification results (e.g., FDA, CE) to streamline registration processes. According to ANVISA’s IN 290/2024 directive: 1. Technical Document Mutual Recognition If a product has obtained FDA or CE certification, ANVISA may directly adopt its technical evaluation results (e.g., design validation, performance testing, biocompatibility), minimizing redundant reviews. For example, clinical data and risk assessment reports (ISO 14971) from CE certification can be directly used to support Brazilian registration, avoiding resubmission. 2. On-Site Audit Exemption For Class III and IV high-risk devices, if a company holds an MDSAP (Medical ...
- Source: drugdu
- 57
- February 6, 2026
【EXPERT Q&A】What are the requirements of the EU medical device regulations for General Safety and Performance Requirements (GSPR)?

Drugdu.com expert’s response: General Safety and Performance Requirements (GSPR) under EU Medical Device Regulations: A Core Framework for Ensuring Safety and Effectiveness The GSPR, outlined in Annex I of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), serves as the cornerstone for ensuring the safety and effectiveness of medical devices in the EU. Its requirements span multiple critical domains, as detailed below: I. Core Components of GSPR GSPR is structured into three chapters in Annex I of the MDR/IVDR: Chapter 1: General Requirements Based on Risk Management Medical devices must function as intended without endangering the health or safety of patients, users, or third parties. Risks must be reduced to an acceptable level without compromising the risk-benefit ratio. For example, design modifications that lower risks but impair device performance or benefits require re-evaluation. Manufacturers must establish, implement, and maintain a risk management system throughout the device lifecycle (e.g., ...
- Source: drugdu
- 60
- February 4, 2026
【EXPERT Q&A】Why is it necessary to obtain a medical device business license when selling medical devices?

Drugdu.com expert’s response: Selling medical devices requires obtaining a Medical Device Business License, which is based on a comprehensive consideration of legal mandatory requirements, ensuring product quality and safety, maintaining market order, enhancing corporate competitiveness, avoiding operational risks, and promoting standardized corporate management. The specific analysis is as follows: I. Legal Mandatory Requirements According to relevant laws and regulations such as the Regulations on the Supervision and Administration of Medical Devices, enterprises selling medical devices must obtain the corresponding Medical Device Business License. This is a mandatory regulatory measure by the state for the circulation of medical devices, aiming to ensure the safety, effectiveness, and traceability of products from the factory to consumers. Operating without a license will result in severe legal penalties, including confiscation of illegal gains, fines of up to 20 times the value of the goods (with a minimum of 50,000 yuan), and in serious cases, revocation of ...
- Source: drugdu
- 58
- February 2, 2026
【EXPERT Q&A】Is it risky to register Class III medical devices?

Drugdu.com expert’s response: The registration of Class III medical devices entails significant risks, which are manifested in multiple dimensions such as technology, process, regulations, clinical trials, documentation preparation, market dynamics, and post-registration supervision. Below is a detailed analysis: High Technical Difficulty: Class III medical devices are primarily used for diagnosis and treatment, directly involving the life and health safety of patients. They have extremely high requirements for product safety and effectiveness. These products often incorporate advanced technologies such as artificial intelligence and robotics, with stringent technical standards. Ensuring product safety while meeting technical requirements poses a major challenge in the registration process. Complex Registration Process: The registration process for Class III medical devices is intricate, involving multiple stages of approval and filing, including product technical requirements, clinical trials, and quality system assessments. With increasingly stringent national reviews and regulations on Class III medical device registration, the time cost required for ...
- Source: drugdu
- 98
- January 28, 2026
【EXPERT Q&A】What certifications are required for the export of medical devices to Brazil?

Drugdu.com expert’s response: Medical devices exported to Brazil must obtain ANVISA certification (core market access certification), INMETRO certification (for specific high-risk products), quality management system certification (e.g., ISO 13485), and ensure labeling and instruction compliance. Certain products may also require ANATEL certification (for wireless communication functionality) or MDSAP audit (as an alternative to ANVISA review). Below is a detailed explanation: I. ANVISA Certification: Core Market Access Threshold Scope of Application: All medical devices imported or distributed in Brazil, regardless of risk classification, must obtain ANVISA certification. Key Requirements: Mandatory Registration: Applications must be submitted online through ANVISA’s SGP system, covering all classified medical devices. Risk-Based Classification: Devices are categorized into four classes (Class I: low risk; Class II: moderate risk; Class III: high risk; Class IV: extremely high risk), with varying documentation requirements: Class I: Basic information and technical documentation; simpler review process. Class II: Detailed technical documentation; may require performance test reports. Class III: Complete clinical ...
- Source: drugdu
- 80
- January 26, 2026
【EXPERT Q&A】How to apply for the quality management system verification of the registration of Class III medical devices within the territory?

Drugdu.com expert’s response: Application Process for Quality Management System Verification of Class III Medical Device Registration within China I. Submission of Registration Application and Verification Materials: The applicant must submit a quality management system verification application simultaneously with the Class III medical device registration application to the National Medical Products Administration (NMPA). Within 10 days of accepting the registration application, the NMPA will notify the corresponding provincial, autonomous regional, or municipal drug regulatory authority (provincial authority) to initiate the verification. II. Verification Notification and Material Preparation: Within 10 working days of accepting the application, the NMPA’s Center for Medical Device Evaluation (CMDE) will send the quality management system verification notification, relevant materials, and an electronic copy of the registration application form to the provincial authority. For cases involving cross-provincial contract manufacturing, the notification will only be sent to the provincial authority where the registrant is located, which shall then coordinate ...
- Source: drugdu
- 65
- January 23, 2026
【EXPERT Q&A】What certifications are required for the export of active pharmaceutical ingredients to Brazil?

Drugdu.com expert’s response: I. ANVISA Certification (Core Certification) The Brazilian National Health Surveillance Agency (ANVISA) is the primary regulatory authority for the export of active pharmaceutical ingredients (APIs) to Brazil. Its certification requirements include: 1. Registration Application Foreign companies must submit applications through a Brazilian-based registered agent (a qualified company or professional) responsible for document preparation, submission, and communication with ANVISA. Application documents must include: Drug composition, dosage form, dosage, pharmacological mechanism, manufacturing process, and quality management system (GMP). Clinical trial data (for new drugs) or bioequivalence study data (for generic drugs). Pharmacological and toxicological research data, stability data, etc. 2. Labeling and Packaging Insert Labels must be in Portuguese and include the drug name, ingredients, dosage form, indications, usage instructions, dosage, and adverse reactions. The packaging insert must provide detailed usage instructions, including indications, dosage, adverse reactions, contraindications, etc. 3. Review and Approval ANVISA reviews the drug’s safety, efficacy, and manufacturing compliance (GMP). ...
- Source: drugdu
- 64
- January 21, 2026

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