Medical devices On the first day of the New Year in 2024, what I want to share with you the most is the medical device registrant system, which has become more and more mature at the institutional level and operational level after years of pilot and promotion. This article will talk about the requirements for commissioned production by medical device registrants.
The requirements for commissioned production by medical device registrants are mainly in the following nine aspects:
1. Requirements for medical device quality management system
Under the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Measures for the Administration of Medical Device Registration and Filing, the entrusted parties shall establish the entrusted production management system documents and organize and manage the activities related to the entrusted production.
2. Personnel requirements
The entrusting party shall be equipped with full-time quality management personnel, who are familiar with the key quality control and key production operation requirements of the product, and can evaluate, audit and supervise the quality management system of the registrant and the entrusted production enterprise.
The entrusted production enterprise shall have the person in charge of production, the person in charge of quality, and the auditor of production release, and these key personnel shall be familiar with the key quality control and key production operation requirements of the entrusted products.
3. Quality Assurance Agreement
The agreement shall at least include the production conditions of the entrusted production enterprise, the transfer of technical documents, the control of material procurement, the control of production process and process, the inspection of finished products, the control of product release, the control of documents and records, the control of changes, the audit of the quality management system, etc., to ensure that the entrusted production enterprises organize production in accordance with laws and regulations, medical device production quality management practices, mandatory standards, and product technical requirements.
Fourth, the system review
There are two requirements for system audit, one is the first audit before the commissioned production, and the other is the regular audit in the commissioned production process.
Requirements for the first audit: Before entrusting production, the quality management system of the entrusted production enterprise shall be assessed and audited on an on-site basis, and the audit content shall at least include institutions and personnel, plant and facilities, equipment, production management, quality control capabilities, etc., to ensure that the entrusted production enterprise has a quality management system suitable for the entrusted production products.
Regular audit requirements: The applicant shall regularly review the entrusted production management and related records of the entrusted production enterprise, and keep the audit records. The entrusted production enterprise shall keep all production records related to the entrusted production, and may provide them to the applicant at any time for future reference.
5. Medical device design, development and conversion activities
Both parties shall jointly plan and complete the design conversion activities to ensure that the product technical requirements, production processes, raw material requirements, and product technical documents such as instructions and labels can be effectively transferred to the entrusted production enterprise.
6. Production process management
The two parties have clear monitoring methods and standards for the production process such as product process flow, process parameters, outsourcing processing process (such as: irradiation sterilization, ethylene oxide sterilization, anodizing, spraying process, etc.), material flow, batch number and identification management, production record traceability, etc., designate authorized monitoring personnel, and keep monitoring records.
7. Document management
The documents jointly held by both parties shall at least include: the entrustment agreement, the product technical requirements, raw material requirements, production process and inspection procedures, product instructions and labels, and product release procedures implemented by the entrusted manufacturer.
8. Product release management
The two parties establish product release review and approval procedures, and ensure that both parties release registered inspection products, clinical trial products and marketed products in accordance with their respective responsibilities. The entrusted production enterprise shall formulate production release review procedures, and shall ensure that the entrusted production products meet the applicant's acceptance standards and keep release records.
9. Communication mechanism and information flow
The two sides shall establish an effective communication mechanism, and any design changes and procurement changes shall be notified to the entrusted production enterprise in a timely manner and the implementation shall be supervised. Changes to the quality management system of the entrusted production enterprise that may affect the quality of the product.