MOH Interaction and Regulatory Liaison Support

Establishing proficient and efficient communication with region-specific Ministries of Health (MOHs) or equivalent health agencies is essential while navigating medical device approvals. Each country has its own set of mandated documents, communication, and language protocols. If not managed compliantly, there is a risk of delay in approvals and it in turn impacts the device’s time-to-market.

Vigilare’s regulatory team is spread across nations, which gives us a competitive edge in understanding local nuances for MOH interactions and regulatory liaison support. Leveraging our experience in managing regulatory agency communications, from pre-market consultations to audit responses and post-market commitments, we ensure effective and timely engagement with health authorities worldwide. We support device manufacturers with in-person meetings with MOH, decoding submission feedback and queries, and labeling and technical file translations.

Vigilare’s MOH Interaction and Regulatory Liaison Expertise

Liaison with MOH / Agency for Approvals

We support and represent our clientele across the MOH approval process. We ensure that required regulatory steps are precisely followed and assist with:

End-to-end engagement with MOH officials
Monitoring and follow-up of device submissions

Unparallel support for review cycles

MoH Interaction in Local Language for Communication Ease

With Vigilare, communication in the local language is never a barrier to dealing with local MOHs or health authorities. We ensure 100% accuracy in translation with:

Bilingual or multilingual support provision
Translation of regulatory information in native language

Submission clarifications

Local Presence for In-Person MOH Meetings & Feedback Handling

Without direct representation in person, few regulatory reviews will be challenging. Vigilare has a presence across 100+ countries, and is equipped for:

Local regulatory representation for MOH meetings
In-person follow-ups for submissions or responses to queries
Preparation for regulatory hearings

Assistance during agency audits or site inspections

Support for Labelling & Technical File Translations

Vigilare representatives assist device manufacturers with accurate information translations, especially for labeling documentation and technical files. We aim to avoid regulatory delays with accurate interpretations. Our translation services include:

Translation of Instructions for Use (IFUs), packaging, and safety labels
Technical documentation conversion as per MOH standards

Compliance with local labeling templates

Facts to Focus

Device Applications

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Testimonials

Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.

We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.

Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.

We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.

Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.