GMA – Type Approval Certification Services

UM offers efficient Global Market Access & Certification Services

When a manufacturer of electronics or electrical equipment decide to market their products globally, there are many unknowns. What international 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 prior to 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.

UM provides targeted direction on meeting labeling requirements, packaging requirements, shipping form entry, and user manual requirements. Our guidance help 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. UM can manage all aspects of Global Market Access including coordinating testing to specific country requirements, providing local representation for customers that have no presence within the respective countries, create the technical compliance files and work 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

• Testing coordination and scheduling services for test the mitigated items

• Preparation of a new technical dossier and approval forms

• Application package submission to Authorities

• International standards identification