Expert Q&A – Page 2 – media

【EXPERT Q&A】What are the main materials required for the registration and application of Class II medical devices in China?

Drugdu.com expert’s response: The registration application for Class II medical devices in China requires a range of materials covering multiple aspects to ensure the safety, effectiveness, and quality controllability of the products. Below are the main materials and their detailed descriptions: I. Basic Application Documents Medical Device Registration Application Form: It must be signed by the legal representative or person in charge and stamped with the official seal. All items filled in should be complete and accurate, consistent with the subsequent materials submitted. Usually, two copies are required, with one copy not bound and provided separately. Medical Device Manufacturer Qualification Certificate: Includes a copy of the “Medical Device Manufacturing License” and a copy of the “Business License”. The product applying for registration should fall within the production scope specified in the “Medical Device Manufacturing License”. Both the “Medical Device Manufacturing License” and the “Business License” must be valid. II. Product ...
- Source: drugdu
- 67
- January 19, 2026
【EXPERT Q&A】In vitro diagnostic reagents, if there are changes to matters not stated in the registration certificate and its attachments, is it necessary to apply for a change of registration?

Drugdu.com expert’s response: In the case of in vitro diagnostic reagents, if changes occur to matters not specified in the registration certificate and its attachments, there is no need to apply for a variation of registration. According to the “Measures for the Registration and Filing of In Vitro Diagnostic Reagents” and relevant regulations, when changes occur to matters not specified in the registration certificate and its attachments for in vitro diagnostic reagents, enterprises are not required to apply for a variation of registration with the original registration authority. However, they must control the changed content through their internal quality management systems, with the specific requirements as follows: I. Scope of Changes Not Involving the Registration Certificate Changes to matters not specified in the registration certificate and its attachments typically include, but are not limited to: Adjustments to packaging formats or specifications (e.g., changing from bulk packaging to single-dose packaging); Changes ...
- Source: drugdu
- 69
- January 16, 2026
【EXPERT Q&A】What is the primary condition for the registration of imported medical devices?

Drugdu.com expert’s response: The primary condition for the registration of imported medical devices is that the product must have been approved for marketing and sales in the country (or region) where the applicant or filer is registered or where the manufacturing address is located. This condition serves as the foundation for ensuring the legality and safety of imported medical devices, and can be understood from the following aspects: Legal Basis Article 13 of the Medical Device Registration Regulations (Order No. 4 of the CFDA) explicitly stipulates that imported medical devices applying for registration or filing must have been approved for marketing and sales in the country (or region) where the applicant or filer is registered or where the manufacturing address is located. The Regulations on the Supervision and Administration of Medical Devices also emphasize the requirement for imported medical devices to have been marketed abroad, ensuring compliance with international or local medical device regulatory ...
- Source: drugdu
- 63
- January 14, 2026
【EXPERT Q&A】What is the current situation of high-end medical equipment in China?

Drugdu.com expert’s response: Currently, China’s high-end medical equipment industry is at a critical stage of rapid rise and transformation. Driven by policy support, technological breakthroughs, and an upgrading market demand, it is undergoing a historic leap from “following the lead” to “running alongside” and even “taking the lead” in certain fields. However, the industry as a whole still faces challenges such as achieving breakthroughs in core technologies, increasing market share, and enhancing international competitiveness. Below is a detailed analysis of the current state of China’s high-end medical equipment industry: Market Size and Growth Continued Market Expansion: China has become the world’s second-largest medical instrument market, with the high-end medical device sector also experiencing continuous growth. For instance, in 2024, the market size of high-end medical devices in China reached RMB 580 billion, marking a year-on-year increase of 21.3%, significantly outpacing the global average growth rate. Robust Growth in Sub-sectors: From ...
- Source: drugdu
- 65
- January 12, 2026
【EXPERT Q&A】What are the evaluation criteria for the verification of clinical trials of Class II medical devices?

Drugdu.com expert’s response: The evaluation criteria for the inspection of clinical trials for Class II medical devices primarily encompass three levels: regulations, technical specifications, and specific inspection points, as detailed below: I. Regulatory Basis: Establishing the Top-Level Framework for Inspections Medical Device Supervision and Administration Regulations As the foundational legislation for medical device regulation, it clarifies the management principles for clinical trials, including core requirements such as trial design, subject protection, and data authenticity, providing a legal basis for inspections. Medical Device Registration and Filing Administration Measures This regulates the medical device registration process, emphasizing clinical trials as a critical component of registration applications. It mandates that clinical trial data submitted must be authentic, complete, and traceable, offering procedural guidance for inspections. In Vitro Diagnostic Reagent Registration and Filing Administration Measures Specifically tailored to Class II in vitro diagnostic reagent medical devices, this refines special requirements for clinical trials, such ...
- Source: drugdu
- 81
- January 9, 2026
【EXPERT Q&A】What are the requirements for quality management in medical device production?

Drugdu.com expert’s response: The requirements for the quality management of medical device production cover multiple aspects, aiming to ensure the safety and effectiveness of medical devices. The core is to establish and effectively operate a quality management system to systematically control the entire product lifecycle. The specific requirements are as follows: Establishment and Operation of the Quality Management System Establish a system based on product characteristics: Enterprises should, in accordance with regulatory requirements and in combination with the characteristics of the medical devices they produce, establish a sound quality management system that is compatible with the products and ensure its effective operation. This system covers multiple links such as commissioned research and development, commissioned production, outsourced processing, and commissioned inspection. Quality assurance system and documentation: Enterprises should establish a quality assurance system and possess a complete set of quality management system documents to ensure the effective operation of the quality ...
- Source: drugdu
- 72
- January 7, 2026
【EXPERT Q&A】What are the requirements for the production of Class I medical devices?

Drugdu.com expert’s response: The production of Class I medical devices requires compliance with the following conditions, covering five core aspects: production facilities, equipment, personnel, quality management systems, and regulatory compliance: I. Production Facilities and Environmental Conditions 1. Facility Requirements Production sites must be clean, suitable, and meet the needs of manufacturing processes and quality control. For example, workshops producing medical cotton swabs must maintain hygiene to prevent microbial contamination. For devices with special environmental requirements (e.g., sterile products), compliance with cleanroom standards (such as YY0033 Management Standard for Sterile Medical Device Production) is mandatory. Production facilities must align with production scale and product characteristics, ensuring rational spatial layout to avoid cross-contamination. 2. Environmental Control Depending on product risk levels, some Class I devices may require controlled environmental parameters like temperature, humidity, or cleanliness. For instance, workshops producing liquid dressings must maintain constant temperature and humidity. II. Production Equipment and Inspection Facilities ...
- Source: drugdu
- 83
- January 5, 2026
【EXPERT Q&A】What qualifications does a medical device company need to obtain?

Drugdu.com expert’s response: Medical device companies must obtain corresponding qualifications based on their business type (manufacturing or distribution) and product classification (Class I, II, or III). The details are as follows: I. Manufacturing Qualifications Class I Medical Devices Qualification Name: Class I Medical Device Production Filing Certificate Issuing Authority: Municipal-level drug regulatory administration (at the district level) Requirements: Possess compliant production facilities (e.g., cleanrooms) and equipment (e.g., calibrated instruments), along with quality management system documentation (e.g., quality manuals, work instructions). Submit materials including business license, proof of production site usage rights, and equipment inventory. Class II and Class III Medical Devices Qualification Name: Medical Device Manufacturing License Issuing Authority: Provincial drug regulatory administration (for Class II) or National Medical Products Administration (for Class III) Requirements: Production sites must meet cleanliness, temperature, and humidity standards, with advanced equipment subject to regular calibration. The quality management system must cover procurement, production, and ...
- Source: drugdu
- 93
- January 2, 2026
【EXPERT Q&A】What Do Class I, II, and III Medical Devices Specifically Refer to in the Classification of Medical Devices? What Are the Classification Bases?

Drugdu.com expert’s response: I. Specific Definitions of Class I, II, and III Medical Devices Class I Medical Devices Definition: Medical devices with a low degree of risk, whose safety and effectiveness can be guaranteed through routine management. Typical Products: Surgical knives, medical fever-reducing patches, stethoscopes, tongue depressors, medical magnifying glasses, surgical gowns, examination gloves, etc. Management Requirements: Subject to filing management. Production filing is the responsibility of municipal drug regulatory authorities, and no permit is required for operation. Class II Medical Devices Definition: Medical devices with a moderate degree of risk, requiring strict control and management to ensure their safety and effectiveness. Typical Products: Thermometers, blood pressure monitors, blood glucose meters, medical masks, electrocardiographs, B-ultrasound machines, condoms, etc. Management Requirements: Subject to provincial registration. Production requires a “Medical Device Production License,” and operation requires a “Medical Device Business License.” Class III Medical Devices Definition: Medical devices with a relatively high ...
- Source: drugdu
- 89
- December 31, 2025
【EXPERT Q&A】What are the main testing standards for medical devices?

Drugdu.com expert’s response: The medical device testing standard system is extensive and meticulous, covering multiple dimensions such as physical properties, chemical properties, biocompatibility, electrical safety, environmental adaptability, software functionality, sterilization validation, and service life assessment. Below are some core aspects: I. Physical Property Testing Standards Testing Items: Dimensional accuracy, surface roughness, material hardness, pressure resistance, tensile strength, sealing performance, wear resistance, fatigue life, motion accuracy, positioning accuracy, etc. Relevant Standards: GB/T 16886.1, GB 9706.1, YY/T 0287, GB/T 14710, etc. II. Chemical Property Testing Standards Testing Items: Material composition, chemical stability, leachables/extractables, residual solvents, additive content, heavy metal content, etc. Relevant Standards: Specific standards involving material composition analysis, impurity and additive testing, migration testing, etc. III. Biocompatibility Testing Standards Testing Items: Cytotoxicity tests, skin sensitization tests, intracutaneous reactivity tests, acute systemic toxicity tests, blood compatibility tests, implantation tests, genotoxicity tests, subchronic toxicity tests, etc. Relevant Standards: ISO 10993 series standards (e.g., ...
- Source: drugdu
- 89
- December 29, 2025

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