Article 41 The production enterprise shall establish and document procedures for procurement control to ensure that the products procured meet the prescribed procurement requirements.
Article 42 A production enterprise shall determine the manner and degree of control to be exercised over the supplier and the purchased products in accordance with the impact of the purchased products on the subsequent product realization and the final product. When the products are commissioned, the commissioning party and the entrusted party as the supplier shall meet the requirements of the relevant regulations on the supervision and management of the production of medical devices.
The manufacturer shall evaluate the ability of the supplier to meet its purchasing requirements and establish guidelines for the selection, evaluation and re-evaluation of the supplier.
Producers shall maintain records of the evaluation results and the evaluation process.
If the purchased product is related to the safety performance of the final product, the manufacturing enterprise shall maintain records of all controls exercised over the supplier, which shall be sufficient to confirm that the purchased product ensures the safety of the product.
Article 43 Procurement information shall clearly express the requirements of the procured products, including the category of procured products, specifications and models, specifications, drawings, process requirements, personnel qualifications, quality management system and acceptance guidelines.
Producers should maintain relevant procurement information according to the scope and extent of traceability requirements.
Article 44 The production enterprise shall carry out inspection or verification of the procured products to ensure that they meet the specified procurement requirements and maintain records.
When the inspection or verification is carried out at the site of the supplier, the production enterprise shall stipulate the verification arrangement and the method of product release in the procurement information.
The manufacturer shall inspect the purchased medical device raw materials by batch or verify the inspection report of the supplier.
Article 45 of the animal origin medical devices and allogeneic medical devices manufacturers of the required donor procurement should be strictly controlled, the qualification of the supplier to evaluate, should be procured from legitimate and quality assurance of the supplier, and the supplier signed a procurement agreement, and have a detailed record of the procurement information.
Article 46 of animal origin medical device manufacturers should be used for medical device production of animal origin donor risk analysis and management, the required donor may be infected with viruses and infectious pathogens for safety control and preservation of information, should be formulated to inactivate or remove viruses and other infectious pathogens process documentation, validation and retention of verification reports.
Article 47 of the animal source medical device manufacturers shall sign a long-term supply agreement with the designated supply of animals, in the agreement should be set out in the quality of the donor requirements, and save the relevant qualifications of the supply unit, animal quarantine certificates, animal disease prevention certificates, the implementation of quarantine standards and other information. The production enterprise shall keep the traceability documents and records of the donor.
Article 48 of the allogeneic medical device manufacturers should be required for strict screening of the donor, should be established to screen the technical requirements of the donor, and save the donor pathogens and the necessary serological test reports.
Article 49 The allogeneic medical device manufacturer shall save the donor voluntary donation book. In the voluntary donation book, it should be clear that the donor's actual use of donated tissue, and the donor himself or his legal representative or his immediate family members to sign the confirmation. For allogeneic raw materials used in the production of medical devices, the manufacturer should keep the legitimacy certificate provided by the cooperating medical institutions or the confirmation document of their ethical committees.
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