Global Representation & Registration Services

Medical device market access is broader than a single regulatory submission. It can include intended-use and classification analysis, regulatory strategy, evidence-gap review, quality-system readiness, dossier preparation, local representation, authority submission, labeling and translation, commercial import planning, and post-market maintenance. The applicable work depends on the device, manufacturer, target country, and route. Our global registration service focuses on executing registrations within that wider program.

Start with the product's intended use, claims, technology, risk class, manufacturer and site information, quality-system status, existing approvals, technical and clinical evidence, software or cybersecurity scope, labeling, and supply chain. Then confirm the local applicant or representative model, authority pathway, government fees, translations, testing, review sequence, renewal cycle, and post-market duties. Pure Global records these decisions in a market-specific plan rather than assuming one pathway fits every country.

Not automatically. Some regulators offer reliance, recognition, verification, or abridged routes that can use a prior authorization or assessment as supporting evidence. Eligibility, reference authorities, device scope, certificate status, local testing, labeling, representation, and review depth still vary. A prior approval may reduce duplication, but it does not replace the target country's legal requirements. Our market guides explain the current route for each jurisdiction.

Many markets require a locally established representative, applicant, sponsor, registration holder, or agent when the manufacturer is based abroad, but the legal role and trigger are jurisdiction-specific. The appointment can affect registration ownership, authority communications, labeling, vigilance, renewals, and transfer options. We confirm the eligible entity and responsibility matrix before appointment; see our in-country representation service for how these roles are managed.

There is no single global timeline or fee. The result depends on qualification and classification, authority workload, submission route, dossier readiness, local testing, translations, quality-system or inspection requirements, representative fees, government charges, and the number of review rounds. We separate professional fees from authority and third-party costs and confirm a planning range after the pathway and evidence gaps are known. See service pricing for the current commercial model.

Authorization begins an ongoing lifecycle. Manufacturers may need to maintain establishment and device listings, renew certificates, control product and manufacturing changes, keep labels and representative details current, monitor regulatory updates, handle complaints and vigilance, report serious incidents, coordinate field actions, and preserve distribution traceability. The exact duties remain market-specific, and the legal manufacturer retains responsibilities that cannot be transferred to a consultant or representative.