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 management system. The quality assurance system needs to ensure that the design and development, production management, and quality control activities of medical devices comply with regulations; management responsibilities are clearly defined; the purchased and used raw materials are correct; intermediate products are effectively controlled; verification and confirmation activities meet requirements; production and inspection are carried out strictly in accordance with procedures; each batch (unit) of products is released after review and approval; measures are in place to ensure product quality during storage, transportation, and installation; and commissioned research and development, commissioned production, outsourced processing, and commissioned inspection activities are under control.

Risk Management

Throughout the entire process: Enterprises should integrate the risk management concept throughout the entire operation of the quality management system, and the control measures taken should be commensurate with the risks associated with the products.

Risk management system and review: Establish a quality risk management system. Based on laws, regulations, rules, standards, scientific knowledge, and experience, assess the quality risks throughout the product realization process, verify and implement quality risk control measures to ensure that product quality risks are effectively controlled. At the same time, collect quality risk information throughout the product lifecycle and regularly conduct quality risk management reviews to ensure the continuous effectiveness of quality risk management measures.

Personnel Requirements

Provide sufficient resources: Enterprises should equip themselves with sufficient and qualified personnel, factory facilities, and equipment to achieve quality objectives. Personnel at all levels should jointly participate in activities aimed at achieving quality objectives and assume corresponding responsibilities.

Qualifications and responsibilities of key positions:

Legal representative and principal responsible person of the enterprise: They are fully responsible for the production of medical devices and are responsible for organizing the formulation of the enterprise's quality policy and quality objectives; ensuring the availability of human resources, infrastructure, and work environment required for the effective operation of the quality management system; organizing and implementing management reviews, regularly assessing the operation of the quality management system, and continuously improving it; ensuring that the management representative, the head of the quality management department, and the product release reviewer can perform their duties independently without interference from internal factors of the enterprise; and organizing production in accordance with relevant laws, regulations, rules, mandatory standards, and the registered or filed product technical requirements.

Management representative: Enterprises should appoint a management representative from among their senior management personnel. The management representative of Class II and Class III medical device enterprises should have a bachelor's degree or above in a medical device-related major or an intermediate or higher technical title; the management representative of Class I medical device enterprises should have a junior college degree or above in a medical device-related major. In principle, the management representative should have three or more years of work experience in medical device quality management or production and technical management, be familiar with product production and quality management situations, and have good performance capabilities. Their responsibilities include implementing relevant laws, regulations, rules, mandatory standards, and registered or filed product technical requirements; establishing and maintaining the effective operation of a quality management system compatible with the produced products; ensuring that products meet release requirements and organizing the collection of post-market product quality information; organizing quality management system self-inspections, adverse event monitoring, and recalls, and regularly reporting the operation of the quality management system and improvement needs to the legal representative and principal responsible person of the enterprise; cooperating with drug regulatory authorities in inspections and organizing relevant departments of the enterprise to make timely rectifications in accordance with requirements for identified issues.

Head of the quality management department: The head of the quality management department of Class II and Class III medical device enterprises should have a bachelor's degree or above in a medical device-related major or an intermediate or higher professional technical title; the head of the quality management department of Class I medical device enterprises should have a junior college degree or above in a medical device-related major. The head of the quality management department should have three or more years of experience in medical device production or quality management. Their responsibilities include ensuring that the production and inspection of raw materials and products comply with relevant laws, regulations, rules, mandatory standards, and registered or filed product technical requirements; organizing product release reviews; ensuring that all major deviations and non-conformities during the production process are investigated and handled in a timely and effective manner; organizing post-market product quality management activities to ensure that all product-related returns, complaints, and adverse events are investigated and handled in a timely and effective manner; ensuring the completion of product quality annual review analyses; ensuring that personnel in the department have received relevant training and master relevant regulations, theoretical knowledge, and practical operation skills; and being responsible for other activities related to product quality.

Head of the production management department: They should have a junior college degree or above in a medical device-related major and three or more years of experience in medical device production or quality management. Their responsibilities include ensuring that production is carried out in accordance with production process procedures and work instructions; ensuring that production records are true, accurate, complete, timely, and traceable; organizing the maintenance and upkeep of factory facilities and equipment to ensure their good operating condition; ensuring that employees in the department have received training and possess the knowledge and practical operation skills appropriate for their job requirements; and being responsible for other activities related to product production.

Release reviewer: They should be personnel from the quality management department or higher-level quality management personnel, have received training related to product release, possess product release review capabilities, and be able to independently assume product release review responsibilities.

Other personnel: Enterprises should be equipped with a sufficient number of professional technicians, management personnel, production operators, and full-time inspection personnel with corresponding qualifications (including educational background, training, and practical experience). The responsibilities of each position should be clearly defined, with no omissions, and overlapping responsibilities should be clearly specified. All personnel engaged in work that affects product quality should receive training appropriate for their job requirements in terms of regulations, job responsibilities, and practical operation skills to ensure that they clearly understand and comprehend their responsibilities, are familiar with requirements related to their responsibilities, and possess relevant theoretical knowledge and practical operation skills. Enterprises should designate a department or a dedicated person to be responsible for training management, establish a training system, formulate training plans, retain training records, and evaluate the actual effectiveness of training. For personnel engaged in work that affects product quality, enterprises should manage their health according to the characteristics of the products produced and establish health records.

Change Control

Enterprises should establish a change control procedure, determine the type of change management according to the risk level of the impact of the change on the safety, effectiveness, and quality controllability of medical devices and relevant regulatory requirements, review the change, and obtain approval before implementation. When necessary, verification and confirmation of the change should be carried out to ensure that the change does not have an adverse impact on the safety, effectiveness, and quality controllability of the product.

Continuous Improvement

Enterprises should achieve continuous improvement of the quality management system, processes, and product quality through methods such as quality data monitoring, change management, adverse event monitoring, quality risk management reviews, corrective and preventive actions, internal audits, and management reviews.