International Approval of Medical Devices

While requirements differ from country to country, the core information needed by authorities is often very similar. To streamline approvals, your Technical Documentation should be prepared in a format that is widely accepted internationally.

One proven approach is the STED File (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices). This structure, defined by the Global Harmonization Task Force (GHTF), helps manufacturers demonstrate compliance with the essential safety and performance principles recognized in many jurisdictions.

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).