Global Market Access

The CE Marking Authority offers efficient Technical Regulations and Standards Services

When a manufacturer of mechanical, electronics or electrical equipment decide to market their products globally, there are many unknowns. What international regulations and standards apply? Will their products need to be redesigned to comply with specific country requirements? What exactly is needed to legally import and sell their products? Failure to answer these questions before product launch can leave a company with delays and loss of revenue. Furthermore, shipping products into countries without the correct certifications may lead to shipments being impounded, equipment being denied commercialization by the regulatory authorities and open the manufacturer up for substantial legal consequences.

The CE Marking Authority provides targeted direction on meeting product safety standards, labelling requirements,  and user manual requirements. Our guidance helps our clients’ products pass through customs quickly, assuring products meet time-to-market deadlines.

We will represent your company as an extension of your compliance team. Our professional regulatory engineers will create a roadmap for global compliance, including a strategy for each country that has unique requirements. The CE Marking Authority can advise on all aspects of Global Market Access including establishing the testing to specific country requirements, creating the technical compliance files and working with local regulatory authorities to get you the required certifications to import your equipment legally.

Services Include:

  • Confirm the Technical Construction File has all the required documents.

  • Review and validate all regulatory & device documents

  • Assessment/Confirmation if appropriate Test Standards & Directives were applied

  • International standards identification