Expert Q&A – Page 5 – media

【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
- 135
- 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
- 139
- 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
- 242
- 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
- 123
- March 30, 2026
【EXPERT Q&A】What are the reasons for the increase in the prices of innovative drugs?

Drugdu.com expert’s response: The reasons for the rise in innovative drugs are mainly as follows: Policy Support Establishment of a Systematic Support System: The “Full-Chain Support Plan for the Development of Innovative Drugs” introduced in 2024 has constructed a systematic support system for the innovative drug industry, covering the entire process from R&D to commercialization. It highlights the synergistic effects of the three core areas: pricing mechanisms, medical insurance payments, and commercial insurance, ensuring that innovative drug companies can make profits from selling drugs, accelerating the speed at which innovative drugs are included in medical insurance lists, and shortening the post-launch market ramp-up period. Advancement of Priority Review and Approval Policies: For instance, on May 29, 2025, 11 innovative drugs (including 7 Class 1 innovative drugs) were approved in a single day, setting a new high for the same period in the past five years and underscoring the direct boost ...
- Source: drugdu
- 157
- March 27, 2026
【EXPERT Q&A】Is it necessary to file for record when operating Class I medical devices?

Drugdu.com expert’s response: Operating Class I medical devices does not require filing. This conclusion is primarily based on the following points of evidence and explanations: I. Classification Management of Medical Devices According to the “Regulations on the Supervision and Administration of Medical Devices” and related regulations, medical devices are classified into Class I, Class II, and Class III based on their risk levels, from low to high. Different categories of medical devices have varying management requirements in terms of operation and production. Class I medical devices: These are medical devices with a low risk level, and their safety and effectiveness can be ensured through routine management. These devices typically have simple structures and are easy to operate, such as surgical knives, surgical scissors, gauze bandages, and other basic medical supplies. Class II medical devices: These are medical devices with a moderate risk level that require strict control management to ensure ...
- Source: drugdu
- 148
- March 25, 2026
【EXPERT Q&A】How to apply for a medical device production license?

Drugdu.com expert’s response: I. Application Requirements 1. Basic Requirements Possess production facilities, environmental conditions, manufacturing equipment, and qualified technical personnel suitable for the medical devices to be produced. Establish a quality inspection department staffed with full-time inspectors and equipped with necessary testing instruments. Develop and implement a quality management system covering production, quality control, and technical documentation to ensure medical device quality. Demonstrate after-sales service capabilities appropriate for the medical devices produced. 2. Personnel Requirements Production, quality, and technical managers must possess professional expertise relevant to the medical devices produced and be familiar with applicable regulations and technical standards. The quality manager shall not concurrently serve as the production manager. The proportion of technical personnel with junior professional titles (or above) or secondary vocational education (or higher) within the enterprise must meet product-specific requirements. For Class III medical device manufacturers, at least two internal auditors compliant with quality management system ...
- Source: drugdu
- 204
- March 23, 2026
【EXPERT Q&A】What are the common requirements for the registration materials of domestic Class II medical devices?

Drugdu.com expert’s response: A series of documents are required to be submitted for the registration of Class II medical devices in China to ensure the safety, effectiveness, and compliance of the products. The general requirements are as follows: Application Form Fill out and submit the “Application Form for Domestic Medical Device Registration,” which must include a unified approval code. Corporate Qualification Documents A copy of the business license, ensuring that the applied-for product falls within the production or business scope approved by the business license. A copy of the organizational code certificate (if applicable). Medical device manufacturing license (if production is involved). Product Technical Documents Product Technical Requirements: Compiled in accordance with relevant standards, including technical indicators, performance requirements, testing methods, etc. Product Drawings, Structural and Composition Descriptions, and Product Photos: Provide clear visual representations and descriptions of the product. Detailed Technical Documents: Such as product design drawings, production processes, ...
- Source: drugdu
- 163
- March 20, 2026
【EXPERT Q&A】What are the major steps in an FDA application?

Drugdu.com expert’s response: The steps for FDA application can be summarized into the following core stages, taking into account the commonalities and differences among product types (food, drugs, medical devices, etc.). The specific process is as follows: I. Preliminary Preparation: Clarify Product Classification and Regulatory Requirements 1. Determine Product Classification Food: Classified into general food, special food (e.g., infant food), dietary supplements, etc. Some require FCE/SID registration (e.g., low-acid canned food). Drugs: Classified into new drugs (NDA), generic drugs (ANDA), biological products (BLA), etc., with different application paths for each category. Medical Devices: Classified into Class I (low risk), Class II (medium risk), and Class III (high risk) based on risk level, determining the application type (e.g., 510(k), PMA). 2. Confirm Regulatory and Standard Requirements Comply with regulations such as the Federal Food, Drug, and Cosmetic Act (FDCA) and the Medical Device Amendments. Reference international standards (e.g., ISO 13485, IEC ...
- Source: drugdu
- 170
- March 18, 2026
【EXPERT Q&A】What are the differences in the registration application requirements for in vitro diagnostic (IVD) medical devices between China and the European Union?

Drugdu.com expert’s response: Differences in Registration Application Requirements for In Vitro Diagnostic (IVD) Medical Devices between China and the European Union The differences in registration application requirements for IVD medical devices between China and the European Union are mainly reflected in classification rules, conformity assessment paths, technical documentation requirements, quality management systems, clinical evaluations, and post-market surveillance and traceability. Here is a detailed introduction: I. Classification Rules China: Based on risk, IVD products are classified into Class I, II, and III. The classification rules are relatively clear, with reference to the detailed “Classification Catalog of In Vitro Diagnostic Reagents.” European Union (IVDR): Based on risk, IVD products are classified into Class A, B, C, and D (with risk increasing from low to high). The classification rules are more refined and stricter, following the rules in Annex VIII. A key change under the IVDR is that a large number of products ...
- Source: drugdu
- 198
- March 16, 2026

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