Expert Q&A – media

【EXPERT Q&A】What requirements does the EU in vitro Diagnostic (IVDR) regulation have for product instructions?

Drugdu.com expert’s response: Core Requirements for Product Instructions under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) to Ensure Safety, Effectiveness, and Proper User Application I. Basic Information Requirements Manufacturer and Authorized Representative Information Must include the manufacturer’s full name, address, and the name and address of the EU authorized representative (if the manufacturer is located outside the EU). Example: If the manufacturer is based in China, the EU authorized representative’s contact details must be clearly indicated. Product Identification and Classification Must specify the product name, model number, unique device identifier (e.g., UDI code), and IVD product classification (Class A/B/C/D). Example: The front page of the instructions should clearly state: “Product Name: XX Blood Glucose Meter, Classification: Class B.” CE Marking and Compliance Statement Must include the CE mark and indicate compliance with IVDR requirements. Example: Display “CE 2017/746” prominently on the cover or a visible location, along ...
- Source: drugdu
- 43
- April 20, 2026
【EXPERT Q&A】Is a ventilator the same as an oxygen generator? What’s the difference?

Drugdu.com expert’s response: Ventilators and oxygen concentrators are different, with significant disparities in their functional positioning, working principles, applicable populations, output gases, usage scenarios, and equipment structures, as detailed below: Functional Positioning Ventilator: Primarily used to assist or replace a patient’s respiratory function, helping those unable to breathe autonomously or with inadequate respiratory function to complete breathing movements and maintain airway patency and respiratory function. It is suitable for patients with respiratory failure, apnea, and other respiratory dysfunctions. Oxygen Concentrator: Mainly used to increase the oxygen concentration in inhaled air, providing high-concentration oxygen to hypoxic patients to improve their hypoxic state. It is suitable for individuals who are hypoxic but have basically normal respiratory function, such as patients with chronic obstructive pulmonary disease (COPD) and heart failure. Working Principles Ventilator: It pushes air into the lungs through mechanical force, simulating the human breathing process and regulating the rhythm and depth ...
- Source: drugdu
- 60
- April 17, 2026
【EXPERT Q&A】What should I do with the registration certificate for Class II medical devices?

Drugdu.com expert’s response: Process and Key Points for the Registration of Class II Medical Device Products I. Eligibility Requirements 1. Corporate Qualifications The applicant must be a legally registered enterprise within China, with a business license covering medical device production or operation. The enterprise must have passed GMP certification and possess a quality management system, production facilities, and testing equipment commensurate with its production scale. For imported products, the applicant must provide an Import Medical Device Registration Certificate and information about the authorized agent. 2. Product Requirements The product must comply with national mandatory standards and not be listed on prohibited production or sales lists. Clinical trial conclusions (issued by at least three medical institutions, stating “satisfactory safety and efficacy”) are required. Information such as indications and scope of use must align with the product instructions and regulatory requirements. 3. Personnel and Facilities The enterprise must employ full-time quality management personnel with ...
- Source: drugdu
- 61
- April 15, 2026
【EXPERT Q&A】Is it necessary to conduct environmental test-related inspections during the CE registration of active medical devices?

Drugdu.com expert’s response: Active medical devices typically require environmental test-related inspections during CE registration, which is a necessary step to meet the General Safety and Performance Requirements (GSPR) under the EU Medical Device Regulation (MDR 2017/745) or the older Directive (MDD 93/42/EEC). Below is a detailed analysis of this requirement: I. Regulatory Basis and Core Requirements Regulatory Requirements According to EU medical device regulations, technical documentation must include “evidence of the device’s suitability under normal and extreme environmental conditions.” Environmental testing is a crucial means to demonstrate this, ensuring that the product remains compliant with safety and performance requirements under varying climatic and mechanical stress conditions. Risk Control Electronic components, batteries, sensors, and other parts of active devices (such as monitors and ventilators) are susceptible to factors like temperature, humidity, and vibration. Environmental testing can expose potential defects (e.g., circuit failures, material degradation) in advance, reducing clinical risks. II. Specific ...
- Source: drugdu
- 72
- April 13, 2026
【EXPERT Q&A】What standards need to be followed for clinical performance studies under the EU IVDR regulation?

Drugdu.com expert’s response: Under the EU’s In Vitro Diagnostic Regulation (IVDR), clinical performance studies must adhere to the following core standards to ensure the scientific validity, reliability, and compliance of the study results: I. Regulatory Framework and Core Requirements 1. IVDR Regulation (Regulation (EU) 2017/746) Clinical performance studies must comply with the requirements outlined in Articles 57-77 and Annex XIV of the IVDR, covering aspects such as study design, ethical review, subject protection, and data management. It is necessary to demonstrate the scientific validity, analytical performance, and clinical performance of in vitro diagnostic reagents (IVDs), ensuring their association with specific clinical conditions or physiological states. 2. ISO 20916:2024 Standard Core Role: As a harmonized standard under the IVDR, ISO 20916 provides a comprehensive framework for the planning, design, implementation, documentation, and reporting of clinical performance studies. Key Content: Presumption of Conformity: Compliance with the normative clauses of ISO 20916 is ...
- Source: drugdu
- 87
- April 10, 2026
【EXPERT Q&A】What are the compliance requirements for labels in the EU medical device CE audit?

Drugdu.com expert’s response: In the EU Medical Device CE Certification review, compliance requirements for labeling are of utmost importance to ensure that products conform to relevant regulations and standards. Below is a detailed summary of these requirements: I. Basic Label Content Requirements Product Identification Information: Labels should include essential information such as the product model, batch number, and expiration date to enable regulatory authorities and consumers to accurately understand the product’s information and performance characteristics. Manufacturer Information: The label should clearly indicate the manufacturer’s name, address, as well as the product model and serial number (if applicable). This information aids in tracing the product’s origin and compliance. CE Mark: Products must bear the CE mark in a prominent location, which is a mandatory indication that the product complies with relevant EU regulations. The CE mark should be clearly visible and resistant to wear. Its color is typically white letters on ...
- Source: drugdu
- 81
- April 8, 2026
【EXPERT Q&A】How should the biocompatibility of medical devices be carried out?

Drugdu.com expert’s response: The development of medical device biocompatibility requires adherence to a systematic process, integrating international standards (such as the ISO 10993 series) and domestic regulations (such as the GB/T 16886 series), and implementing it in stages from preliminary preparation to continuous monitoring. The specific steps are as follows: I. Preliminary Preparation and Risk Assessment Clarify Device Information Determine the intended use (e.g., implantation, contact with blood/mucous membranes/skin), duration of contact (short-term, long-term, or permanent), and material composition (main structure, coatings, connecting components, etc.). Example: A cardiac stent requires long-term implantation in blood vessels, necessitating a focus on evaluating tissue compatibility and blood compatibility. A disposable syringe requires attention to skin irritation and cytotoxicity. Identify Potential Risks Analyze the biological reactions that materials may trigger, such as allergies, cytotoxicity, local inflammation, coagulation, or hemolysis. Example: Nickel-containing metal materials may cause allergic reactions; rough-surfaced materials may damage tissue cells. Determine ...
- Source: drugdu
- 89
- April 6, 2026
【EXPERT Q&A】What is the specific process for obtaining a medical device product registration certificate?

Drugdu.com expert’s response: The Process for Obtaining a Medical Device Product Registration Certificate Involves Multiple Steps, Detailed as Follows: I. Preliminary Preparation and Classification Confirmation Product Classification Determination: Based on the Medical Device Classification Catalog and classification criteria, the category is determined by considering factors such as the intended use and mechanism of action of the product. For example, blood glucose test strips fall under Class II, while artificial heart valves are classified as Class III. If no matching category can be found in the existing catalog, a classification determination must be conducted beforehand. Selection of Registration Pathway: Domestic enterprises should proceed with the registration process, while imported products must appoint a domestic agent. For renewal of registration, applications should be submitted six months prior to the expiration of the certificate. Preparation of Technical Requirement Documents: These documents should cover product standards, performance indicators, and test reports, referencing relevant standards. For instance, orthopedic implants must ...
- Source: drugdu
- 87
- April 3, 2026
【EXPERT Q&A】What testing and certification are required for the export of pharmaceutical products to Japan

Drugdu.com expert’s response: Pharmaceutical products exported to Japan must obtain certification from Japan’s Ministry of Health, Labour and Welfare (MHLW) and meet the following testing and certification requirements: I. Core Certification Requirements 1. Drug Certification Basis of Regulations: Primarily based on the Pharmaceutical and Medical Device Act (Pharmaceutical Affairs Law) and the Food Sanitation Act. Testing Content: Includes ingredient analysis, efficacy evaluation, and safety testing, covering physical and chemical property testing, biological activity testing, and contaminant testing, among others. Certification Process: Submit detailed technical documentation and ingredient descriptions of the product. Provide production process flow and quality control measures. Submit previous testing reports and certificates of compliance. Provide relevant clinical trial data (if applicable). 2. Medical Device Certification PMDA Certification: Medical devices must obtain certification from the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s regulatory body for pharmaceuticals and medical devices, to ensure compliance with Japanese safety, efficacy, and quality ...
- Source: drugdu
- 94
- April 1, 2026
【EXPERT Q&A】How to carry out clinical evaluation of medical devices?

Drugdu.com expert’s response: Conducting clinical evaluation of medical devices is a critical step to ensure their safety, efficacy, and compliance with regulatory requirements. It must be carried out in accordance with regulations such as the Regulations on the Supervision and Administration of Medical Devices and the Technical Guidelines for Clinical Evaluation of Medical Devices, while selecting an appropriate pathway and implementing it systematically based on the characteristics of the product. Here are the specific steps and key points: I. Clarify the Clinical Evaluation Pathway Select one of the following three pathways based on the risk level and maturity of the medical device: 1. Products Listed in the Catalog Exempt from Clinical Evaluation Applicability: Low-risk products with mature technologies (e.g., some Class I and Class II devices). Requirements: Confirm that the product is fully consistent with the description in the catalog, including structural composition, performance, and intended use. Submission: Submit a declaration without additional ...
- Source: drugdu
- 87
- March 30, 2026

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