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EU CE certification

2025-11-13

In the EU market, the "CE" mark is a mandatory certification mark. Whether it is a product produced by internal enterprises in the EU or products produced in other countries, in order to circulate freely in the EU market, it is necessary to attach the "CE" mark to indicate that the product meets the basic requirements of the EU's "New Methods for Technical Coordination and Standardization" directive. This is a mandatory requirement of EU law for products.EU CE certification refers to basic safety requirements that are limited to products that do not pose a threat to human, animal, and goods safety, rather than general quality requirements. Coordinated directives only specify primary requirements, while general directive requirements are standard tasks. Therefore, the accurate meaning is that the EU CE certification CE mark is a safety conformity mark rather than a quality conformity mark. It is the "main requirement" that constitutes the core of the European Directive.The "CE" mark is a safety certification mark that is considered a passport for manufacturers to open and enter the European market. CE stands for Unification of Europe.More than 1200 certification bodies have obtained EU CE certification, the vast majority of which are located within the borders of EU member states. Normally, an NB is only authorized by the European Union to carry out certification in one or several modes for a certain category or categories of products. In other words, an EU authorized certification body may not be able to certify all product categories, and even for the authorized product categories, it is usually not authorized for all models. For each EU product directive, there is usually an authorized certification body NB directory for that product directive.(1) The Declaration of Conformity/Declaration of Compliance independently issued by the enterprise is a self declaration document and should not be issued by third-party organizations (intermediaries or testing and certification bodies). Therefore, the EU format enterprise Declaration of Conformity can be used as a substitute.(2) Certificate of Compliance is a declaration of conformity issued by a third-party organization (intermediary or testing certification body), which must be accompanied by technical information such as test reports and TCF. At the same time, the enterprise must also sign a Declaration of Conformity.(3) EC Attestation of Conformity is a certificate issued by the notified body (NB) of the European Union. According to EU regulations, only NB is eligible to issue EC Type CE declarations.

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Medical device registration

2025-11-13

Basic information editingMedical device registration is a process in which the food and drug regulatory authorities, based on the application of the applicant for medical device registration, systematically evaluate the safety and effectiveness research and results of the medical device intended for sale in accordance with legal procedures, in order to decide whether to approve their application.Regulatory Regulation Editing1. The Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) were issued on March 7, 20142. The Measures for the Administration of Medical Device Registration (Order No. 4 of the State Food and Drug Administration) were issued on July 30, 20143. The Measures for the Administration of Registration of In Vitro Diagnostic Reagents (Order No. 5 of the State Food and Drug Administration) were issued on July 30, 2014Certificate number codeThe medical device registration number consists of six parts, and the basic arrangement is: X (X) 1 Food and Drug Administration (X2) XXXX3 No. X4XX5XXXX6.X1 is the abbreviation for the location of the registration and approval department. Domestic Class III medical devices, overseas medical devices, and medical devices in Taiwan, Hong Kong, and Macau are referred to as "national". The second category of medical devices within the territory is the abbreviation of the province, autonomous region, or municipality directly under the central government where the registration and approval department is located. The first category of medical devices within the territory refers to the abbreviation of the province, autonomous region, or municipality directly under the central government where the registration and approval department is located, as well as the abbreviation of the city level administrative region where it is located. When there is no corresponding district for a city level administrative region in XX1, it is only the abbreviation of a province, autonomous region, or municipality directly under the central government. X2 is the registration form (approved, advanced, approved). The word "quasi" applies to domestic medical devices, the word "jin" applies to overseas medical devices, and the word "xu" applies to medical devices in Taiwan, Hong Kong, and Macau. XXXX3 is the year of approval for registration, X4 is the product management category, and XX5 is the product variety code. XXXX6 is the registration serial number.On October 1, 2014, the new version of the Medical Device Registration Management Measures came into effect, and the Medical Device Registration Management Measures (formerly Order No. 16 of the State Food and Drug Administration) announced on August 9, 2004 were simultaneously abolished. The new version of the Medical Device Registration Management Measures has redefined the method of writing certificate numbers:The arrangement of registration certificate numbers is as follows:* 1 machine injection * 2 * * * * 3 * 4 * * 5 * * * 6. Among them:1 is the abbreviation for the location of the registration and approval department:Domestic Class III medical devices, imported Class II and Class III medical devices are referred to as "national";The second category of medical devices within the territory refers to the abbreviation of the province, autonomous region, or municipality where the registration and approval department is located;× 2 is the registration form:The word "accurate" is applicable to domestic medical devices;The word "jin" is applicable to imported medical devices;The word "Xu" is applicable to medical devices in Hong Kong, Macau, and Taiwan;XXXXXXXX is the year of first registration;× 4 is the product management category;XXXX5 is the product classification code;XXXXXXX 6 is the first registration serial number.If the registration is continued, the digits of XXXXXX 3 and XXXXXX 6 remain unchanged. If the product management category is adjusted, it should be renumbered.The arrangement of the number of the first type of medical device registration certificate is as follows:Equipment No. 1:.Among them:1 is the abbreviation for the location of the filing department:The first category of imported medical devices is referred to as "national";The first category of medical devices within the territory refers to the abbreviation of the province, autonomous region, or municipality directly under the central government where the filing department is located, plus the abbreviation of the city level administrative region with corresponding districts (when there is no corresponding district level administrative region, only the abbreviation of the province, autonomous region, or municipality directly under the central government);XXXXXX is the year of filing;XXXXXXXX3 is the filing serial number.

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Reanny Medical Devices Management Consulting Co., Ltd.

EU CE certification

Medical device registration