Medical network February 11 hearing recently held in the 'Second Food and Drug Review and Evaluation Technology Summit' Medical Devices Summit ', the relevant speakers on the topic of medical device inspection conducted a speech, the main contents of the following :
Since January 1 this year, the flight inspection work is normalized.
Drug Administration medical instruments The current inspection methods are three kinds, the first is the registration quality system verification, registration of new products before the registration system of quality verification.
The second follow-up inspection, refers to the new product after the listing of a year after the permit enterprise Checked.
The third is a flight inspection, the main is to allow all enterprises to maintain the stability of the production process, the normalization of quality control, product quality is produced, not with a name, name to ensure product quality, which reflects the regulatory concept The shift - pay more attention to process regulation.
The main purpose of flight inspection is to allow enterprises to have a deep understanding of the norms. It is not an objective to deal with enterprises. The purpose is to enable enterprises to jointly improve the management level and enhance the quality level of the entire industry. This is our goal.
Especially for SMEs that do not have the ability to do these things, we would like to help you improve your understanding and control of the code by flying tests.
One of the items that we focused on when examining was key processes and special projects. The key processes and special projects were unique to national norms. There was no such concept in the FDA and ISO 13485, which generally referred to the process that required control.
The key processes and special processes are defined in the specification, but many companies do not have a deep understanding of this definition.
Second, we found blood-related problems in companies doing diagnostic reagents because of the high risk of blood and the potential risk of blood-borne diseases, so we are doing blood-related business and we must pay attention to your management.
There is a situation, many companies in the purchase When faced with the problem is not signed with the supplier quality agreement. Regulations The main raw material is required to sign quality agreements with suppliers, but many companies ignore the quality agreement, because many companies mistaken for the contract, the contract as a quality agreement.
There are differences between the contract and the quality agreement, the main provisions of the contract is some of the price, transport aspects, the quality of the agreement signed mainly your quality requirements for raw materials.
There is also a concept of nonconforming product, many companies have different understanding of nonconforming products, flying problems we found more.
Unqualified products, according to the law, is a product at any stage of the production process is to be in accordance with the management of nonconforming products to be managed.
The management of nonconforming products, such as raw materials, raw materials you purchase after passing the inspection before they can be put into operation. You have put into operation without the risk of relatively large. Another is that you have tested, nonconforming products Expected to use, which is also right product quality A place of great influence.
