According to the risks connected with placing medical devices and in-vitro diagnostics on the market worldwide requires the compliance with the respective regulations. These may differ considerably from country to country based on their respective risk class even if GHTF/IMDRF did make strong efforts for a more consistent regulation. Basis for the application for market access usually is the technical documentation, for which GHTF/IMDRF developped the STED format. Nevertheless, product registration e.g. in the US and in China may require a considerable timely and financial effort.  

Apart from some special national requirements in the EU consistent regulations apply. This underlines the importance of MDR/IVDR which is recognized in the EFTA countries (apart from Switzerland) and Turkey as well. In the EU medical devices have to pass a conformity assessment procedure before they can access the market. For products of a medium and higher risk class the participation of a Notified Body is required in this procedure. Finally, the manufacturer declares conformity of the product with the respective regulation/directive and applies the CE mark to the product.

In most other regions powerful administrations are responsible for the registrations of medical devices like the FDA in the US and the NMPA (former CFDA) in China. Frequently, the respective ministry of health is assigned with their registration like e.g. Health Canada or the Japanese MHLW (Ministry of Health, Labour and Welfare).

I am most willing to support you in getting access to the respective markets for your products! In particular, I did hold a leading position with an EU Notifiied Body and have experience with successful 510(k) and DeNovo submissions to the FDA (incl. clinical trial in the US). But I have also been in charge of bringing an extensive product with hardware, softare, biological and chemical components to market in China (incl. product testing in China) and negotiated with Health Canada in various projects.