At your request, we will also take care of International Approval and Registration. With the help of our worldwide partners, we can register, approve or certify Medical Devices in almost every country in the world. So far, we have been able to support MedTech companies in the following countries/regions:
The requirements for International Approval vary in many countries. However, in the end, the same information is required by the respective approval authorities. To take this into account, your Technical Documentation should be structured in such a way that it is recognized in most countries. The so-called STED File (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices) is helpful. A document published by the Global Harmonization Task Force exists for this purpose.
The STED is intended to be used as evidence of the conformity assessment. The manufacturer creates this file to demonstrate to a regulatory authority that the Medical Device in question complies with the Essential Requirements. For all products, the manufacturer is obliged to carry out a conformity assessment in accordance with the Essential Requirements before placing the product on the market. In certain cases (which mostly depend on the risk class of the product), the STED may need to be reviewed/approved by the regulatory authority or a conformity assessment body before the product in question can be placed on the market. ((c) GHTF-2011).
Contact us for a customized offer for the registration of Medical Devices in the international market.
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
Copyright 2024 WQS Management Consultants GmbH