Expert Q&A – media

【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
- 35
- 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
- 52
- 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
- 50
- 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
- 57
- 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
- 58
- December 29, 2025
【EXPERT Q&A】What are the considerations to keep in mind when applying for EU CE certification?

Drugdu.com expert’s response: When applying for the EU CE certification, the following considerations should be taken into account to ensure a smooth process and compliance with regulatory requirements: I. Clarify the Scope of Certification and Applicability of Directives Confirm Whether the Product Requires CE Certification: Not all products require CE certification. Only those products that fall within the scope of the EU “CE Directives” or “Regulations” must undergo certification and affix the CE mark. Currently, the EU has issued more than 20 CE-related directives, covering common categories such as electronics and electrical appliances, machinery, medical devices, toys, and building materials. Determine Applicable Directives and Standards: Match the corresponding EU directives (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, Medical Device Regulation, etc.) based on the product type, and verify the latest harmonized standards (such as EN 60335-1 for household appliance safety standards). Avoid invalid certification due to incorrect directive ...
- Source: drugdu
- 59
- December 26, 2025
【EXPERT Q&A】What are the requirements for the registration information of domestic active medical device products?

Drugdu.com expert’s response: The registration materials for domestically manufactured active medical device products need to meet various requirements, as detailed below: I. Basic Document Requirements Table of Contents: It should include all main and sub-headings, indicate the page numbers for each content in the table, and clarify applicability (e.g., whether the CR table of contents is applicable). Glossary of Terms and Abbreviations: Define terms or abbreviations that require clarification based on the actual situation of the registration application materials. Application Form: Fill out and upload the application form with a unified approval code exported from the application system (including the power of attorney), in accordance with the form-filling requirements. Product List: List the model numbers, specifications, structures and components, and accessories of the proposed products in tabular form, along with the identification (such as model or part numbers, unique device identifiers, etc.) and descriptive explanations (such as dimensions, materials, etc.) ...
- Source: drugdu
- 64
- December 24, 2025
【EXPERT Q&A】What are the differences between a ventilator and an oxygen generator?

Drugdu.com expert’s response: Respirators and oxygen concentrators exhibit significant differences in functional positioning, working principles, applicable scenarios, and usage methods. Here is a detailed comparative analysis: I. Core Functional Positioning A respirator is a “respiratory support device” whose core function is to replace or assist human breathing. It addresses two types of issues through mechanical ventilation: Insufficient respiratory drive: Such as respiratory failure or neuromuscular diseases (e.g., amyotrophic lateral sclerosis, spinal cord injuries) that render individuals unable to breathe autonomously. Airway obstruction: Such as sleep apnea syndrome (snoring with breathing pauses) or airway spasms during acute asthma attacks. Respirators not only deliver oxygen but also help expel carbon dioxide through positive pressure, maintaining overall gas exchange in the body. An oxygen concentrator is an “oxygen supplementation device” whose core function is to increase the concentration of inhaled oxygen. It extracts oxygen from the air (with oxygen concentrations reaching over 90%) ...
- Source: drugdu
- 70
- December 22, 2025
【EXPERT Q&A】How can I apply for Class II and Class III medical device certificates the fastest?

Drugdu.com expert’s response: To swiftly apply for Class II and Class III medical device certificates, it is essential to clarify the classification requirements, prepare complete materials, submit the application according to the process, and actively cooperate with the review. Additionally, leveraging professional agency services can enhance efficiency. Below is a detailed explanation: I. Clarify Classification and Requirements Class II Medical Devices: These pose moderate risks and require either business registration or production licensing. Class III Medical Devices: These carry higher risks and must obtain business licensing or production licensing. II. Prepare Application Materials Class II Medical Device Business Registration Materials Registration Application Form: Requires the signature of the legal representative and the company seal. Corporate Qualification Proof: Includes a copy of the business license, with the business scope including “Class II medical device sales” or similar wording. Personnel Qualification Proof: Identification documents and educational or professional title certificates of the ...
- Source: drugdu
- 70
- December 19, 2025
【EXPERT Q&A】What are the content and regulatory requirements for the registration materials of domestic non-active medical devices?

Drugdu.com expert’s response: Domestic Registration of Non-active Medical Devices: Required Submission Materials Covering Six Core Areas Including Enterprise Qualifications, Product Technology, Quality Systems, Clinical Evaluation, Packaging and Labeling, and After-sales Service. Specific Content and Regulatory Requirements Are as Follows: I. Enterprise Qualification Documents Basic Certificates: Provide a copy of the business license (stamped with the official seal and valid), organization code certificate, and tax registration certificate (some regions have merged these into a unified social credit code). If the enterprise already holds a Medical Device Business License, this must also be submitted. Personnel Qualifications: Include identity proofs, academic or professional title certificates for the legal representative, enterprise leader, and quality supervisor, along with work resumes of quality management personnel. Additionally, provide a list of professional and technical personnel with their qualifications (e.g., copies of ID cards, academic certificates, and professional title certificates). Special Qualifications: If the product involves innovative medical ...
- Source: drugdu
- 66
- December 17, 2025

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