According to the "supervision and management of medical devices business approach" Article 32: the purchase inspection records and sales records should be kept until two years after the expiration date of the medical device; no expiration date, not less than five years. Implantable medical devices purchase inspection records and sales records should be kept permanently.
Medical device business enterprises shall establish and implement the purchase inspection records system. Engaged in the second and third class medical device wholesale business and the third class medical device retail business enterprises shall establish a sales record system. Incoming inspection records and sales records information should be true, accurate and complete.
Enterprises engaged in the wholesale business of medical devices, its purchase, storage, sales and other records should meet the traceability requirements.
Encourage other medical device business enterprises to establish sales record system.
Expanded:
The Good Manufacturing Practice for Medical Devices came into effect on March 1, 2015, according to the Code of Good Manufacturing Practice for Medical Devices. According to the norms, medical device companies should establish a product traceability program that specifies the scope, extent, labeling and necessary records for product traceability.
The introduction of the norms is aimed at strengthening the supervision and management of medical device production, standardizing the quality management of medical device production, and further safeguarding the safety and effectiveness of public use of devices. The revised specification provides for equipment, procurement, production management, quality control, sales and after-sales, control of nonconforming products, adverse event monitoring, analysis and improvement.
The specification requires that enterprises should carry out production in accordance with the established quality management system to ensure that the products comply with the mandatory standards and the technical requirements of the products that have been registered or filed, and to establish procedures for the traceability of the products.
In terms of quality control, the specification specifies that enterprises should be based on mandatory standards and registered or filed by the technical requirements of the product to develop product testing procedures, and issue the appropriate inspection reports or certificates. Each batch (Taiwan) products should have inspection records, and to meet the requirements of traceability. Inspection records should include incoming inspection, process inspection and finished product inspection records, inspection reports or certificates.
For sales and after-sales service, the specification requires that enterprises should establish product sales records, and to meet the requirements of traceability. Sales records include at least the name of the medical device, specifications, models, quantities; production lot number, expiration date, date of sale, purchase unit name, address, contact information.
The specification also points out that enterprises should establish a medical device adverse event monitoring system in accordance with the requirements of the relevant laws and regulations, carry out adverse event monitoring and re-evaluation work, and maintain relevant records. For the existence of potential safety hazards of medical devices, should be in accordance with the requirements of relevant regulations to take measures such as recall, and report to the relevant departments as required.
Baidu Encyclopedia - Medical Device Business Supervision and Management Measures