A classmedical devices often in direct contact with the patient's body, medical equipment products with a high security risk, strengthen a class of medical equipment management without delay. Recently, Nanjing, Jiangsu Province, in order to be treated in strict supervision of a class of medical device products, the Municipal Food and Drug Administration forward regulatory checkpoints to the registration review process, rigorous review of the medical equipment manufacturer data, comprehensive supervision and management of the enterprise specification do from the source, qualified to ensure product safety and effective.
Review of registration data, do the following: First, review product standards, focusing on the safety and efficacy of the terms of the audit, to ensure technical quality requirements to develop in line with national standards, industrial standards and product safety and efficacy; Second is the based on the review of the performance test report, the increase in factory inspection report format and the verification of test items, to avoid the enterprise certified normal production factory inspection does not meet the regulatory requirements; Third, to test the ability to review, put an end to the test conditions do not have issued false inspection reports; Fourth, for a class of medical device companies, weak awareness of laws and regulations, the PUC check registration certificate, perform the interview system publicize relevant laws and regulations, the main person in charge of the enterprise, the enterprise prone to do in advance to remind; Fifth registration data authenticity verification, further confirmation of the authenticity of the business conditions, forward regulatory checkpoints strict access, reducing the card after the day-to-day supervision of the difficulty, and conserve supervisory resources, and improve regulatory efficiency.
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Author : Fiona |
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