Medical Device Submissions and Medical Device Registrations

The regulatory submissions landscape for devices is being reshaped. FDA has introduced mandatory electronic submissions and developed an eSTAR program demanding all submission data in a structured, and standardized electronic format. EU also mandated electronic submissions. In addition, there exists a lot of variability in classification systems, global submission formats, and timelines. Once the documents are compiled, device manufacturers need to get into strategic submission planning across the regions.

At Vigilare, we extend support for medical device registrations including dossier preparation for technical files. In addition, we assist manufacturers in understanding the product classification and gap analysis of the technical documentation and support them in conformance to local regulatory requirements, especially for CE marking (MDR/IVDR), 510(k), PMA, MHRA DeNovo, and TGA approvals. We optimize the data for each jurisdiction’s unique submission formats, hence to streamline medical device registrations.

Vigilares Medical Device Submissions and Registration Expertise

Medical Device Classification & Gap Analysis of Technical Documentation

Medical device classification is a primary prerequisite for a compliant submission. Any misclassification or improper documentation cause delays, and may attract additional reviews or rejections. To ensure device manufacturers go for a compliant submission, Vigilare offers:

Accurate device classification for FDA, EU MDR, CDSCO, ANVISA, etc.
Assess current technical files for gaps
Mapping the regulatory pathways for compliant medical device registrations

Compilation & Submission of Technical Files to Regulatory Agencies

Each health authority has unique submission requirements. Compiling current technical files requires a proper understanding of each of them for completeness and compliance. At Vigilare, we support device submissions for major regulated health authorities. We are specialized in:

Preparing, and formatting CE Technical Files and FDA 510(k)/PMA dossiers
FDA eSTAR for De Novo submissions
EU MDR and IVDR-compliant submissions
SaMD applications
eSubmissions/eCTD preparation

Optimization of Data for Submission in Multiple Markets

At given scenarios, device manufacturers can adapt the technical data submitted for one health authority to simultaneous submissions aimed at other health authority approvals. In such scenarios, Vigilare offers:

Data and document harmonization to match up with multiple country formats
Localization of clinical data, IFUs, and labels for regional requirements
Tailored and tiered regulatory strategy development for medical device registration

Timeline management and country filing prioritization

Support for Conformance to Local Regulatory Requirements

Starting from device classification to performance testing, each country defines its own regulatory expectations. To assist device manufacturers in meeting those expectations, Vigilare ensures:

Preparation of Country-specific checklist
Conformance with region-specific requirements of EMA, MHRA, TGA (Australia), HSA (Singapore), COFEPRIS (Mexico), and more
Localization and translation of regulatory content
Deficiency responses post-submission

Support for Import Permits / Licenses

A device holder requires regulatory approvals, not only while launching a device in a specific market, but while importing a device from another market too. Either a finished device or a specific component to be imported, regulatory approvals are a must. In such scenarios, Vigilare assists with:

Coordinating for new import license applications and renewals
Dossier preparation as per local health authority guidelines
Communicating with In-country regulatory agents
Medical device registration linkage with authorized importers

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.