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On August 22nd, Ms. Christie Tarija, General Manager of the European Diagnostic Manufacturers Association (EDMA), was invited to Beijing to give a detailed introduction to the regulations of the European Union's in vitro diagnostic reagents. The EU In Vitro Diagnostic Reagents Regulation Seminar was hosted by the State Food and Drug Administration (SFDA). More than 20 people from the Medical Device Evaluation Center, industry associations and some business representatives attended the meeting.
In vitro diagnostic reagents are diagnostic reagents prepared by the principles or methods of immunology, microbiology, molecular biology, etc., used in vitro for the diagnosis, detection and epidemiological investigation of human diseases, including microbial antigens, human genetic testing. , tumor markers, and so on. In China, in vitro biodiagnostic reagents are managed according to drugs, and other types of reagents such as in vitro chemical and biochemical diagnostic reagents are managed according to medical devices.
This classification management model brings some problems: in accordance with the requirements of the Drug Administration Law and the GMP certification of drugs, in vitro diagnostic reagent manufacturers that manage drugs must pass GMP certification. Due to the low output value of some enterprises, the scale of enterprise development is limited, and it is unable to declare GMP certification.
Chang Yongheng, assistant inspector of the SFDA Medical Devices Division, said that since 2005, SFDA has taken the supervision of in vitro diagnostic reagents as a key point. It is exploring a new management model and has begun to draft new management methods. Publicly solicit opinions from all walks of life. The invitation to EU experts to come to China is also to learn from international experience, to achieve scientific supervision and promote the healthy development of the industry.
According to Christie Tarija, the United States, Canada and other countries and the European Union have always classified in vitro diagnostic reagents into device management. The European Commission officially adopted the 98/79/EC In Vitro Diagnostic Device Directive (IVDD Directive) on October 27, 1998, and published it on the European Union Gazette No. L331 of December 7, 1998. According to the contents of the communique, EU member states must complete the relevant regulations and regulations required for the implementation of this Directive by June 7, 2000. Since December 2003, all in vitro diagnostics sold in EU member states. All instruments must be completed in accordance with this Directive in accordance with the conformity assessment procedures and affixed with the CE mark in order to be listed in the EU.
According to the EU's IVDD Directive, in vitro diagnostic reagents are managed separately as a special type of product. In Appendix II of the Directive, the varieties on Catalog A and Catalog B are relatively strict in management due to their high risk level. In addition, the EU self-manages most of the other products with lower risk levels, that is, manufacturers establish quality management systems, retain technical documents, and make self-guaranteed statements, usually without government approval.
Although the specific regulations for the management of in vitro diagnostic reagents in different countries are slightly different, they are generally based on the principle of risk management, and their identification of high risks is also consistent, because after all, unlike drugs and medical devices, they are mainly used in vitro. Most of the in vitro diagnostic reagents are products with a low degree of risk, and about 80% of the products are not at a high risk level. Therefore, this management mode in the EU is relatively easy and the management cost is low.
Shanghai Medical Device Network
