The full English name of SRN is single registration number, which refers to the unique identification of each economic operator on the EU medical device database eudamed and relevant official documents and reports. Generally speaking, SRN is the unique ID number of the manufacturer or importer in the eudamed system, which can realize various identification and traceability effects.

Grzan medical is about to launch the new crown variant Omicron ba 1. Ba 2. Solutions for clinical experimental research of Xe mutant strain. The number of places is limited. Enterprises that need to carry out the experiment can make an appointment in advance.

Canada implements the quality system review of government registration combined with the third party. The third party mentioned here refers to the third party organizations recognized by the Canadian Standards Committee (SCC) that can conduct the audit of the Canadian medical devices conformity assessment system (cmdcas), such as TUV PS, BSI, and other certification companies, hereinafter referred to as the cmdcas accreditation bodies.

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of the medical devices to be marketed and used in accordance with legal procedures, so as to decide whether to agree to their sale and use.

ASEAN CSDT recommended the format of ASEAN CSDT in Annex 4 of the Southeast Asian Medical Device Directive (AMDD), which was signed by ten countries in Southeast Asia: the Philippines, Malaysia, Singapore, Thailand, Brunei, Vietnam, Myanmar, Laos, Cambodia and Timor Leste.

In order to gain access to the Australian market, medical device and IVD manufacturers will need to include their products in the Australian therapeutic drug register (ARTG) regulated by the therapeutic drug administration (TGA). If you have obtained the European CE mark, the TGA approval process will be easier as Australia recognizes the CE mark.

Coronavirus test device approvals, or CTDA for short, is a regulation issued by the British government for the new crown test reagent, which was implemented in July 2021. From November 1, 2021, the new crown detection IVD products that have not applied for and / or passed the CTDA review will not be legally sold in the UK market.

The full English name of mdsap is medical device single audit program. The full Chinese name is a single audit procedure for medical devices. It is one of the coordination projects of imdrf. Imdrf (international medical device regulator Forum) is an international coordinating organization for medical device regulation established in 2012 by the medical device regulators of the United States, the European Union, Australia, Brazil, Canada and Japan on the basis of the original gthf (global medical device regulation coordination organization).

SO9001 quality management system certification standard is a summary of the development of management theory and management practice in many countries, especially developed countries. It embodies a management philosophy and quality management method and mode, and has been adopted by more than 100 countries and regions in the world.

ISO13485 medical device quality management system certification is an important basis for medical devices to meet the requirements of most national laws and regulations, and it is also the embodiment of your commitment to meet customer requirements.

The content of the free sale certificate is usually to prove that the corresponding product is a legally produced and / or sold product that meets the requirements of local laws and regulations in the issuing country. At the same time, the regulatory authority of the destination country accepts the validity of the certificate issued by the issuing country to determine that it also meets the regulatory requirements of the destination country, or as one of its evidences.

Manufacturers of class I medical devices and in vitro diagnostic equipment must obtain a medical device enterprise license (mdel) if they sell the equipment directly to Canada instead of through distributors. However, if it is sold to Canada through a distributor, your distributor must obtain mdel. Distributors and importers of medical devices and in vitro diagnostic equipment, regardless of the classification of medical devices, must obtain mdel.