Legal Manufacturer as a Service: Your legal manufacturer for medical devices in over 30 countries
As an experienced legal manufacturer, BAYOOCARE assumes full manufacturer responsibility for your medical device – from classification and CE marking to post-market surveillance. You concentrate on development and marketing, we take overall regulatory responsibility.
Strategic market access instead of a regulatory patchwork
Manufacturers of medical devices face particular challenges when expanding internationally. Each market defines risk classes differently, requires its own formats for technical documentation and has specific requirements for product testing. What is considered Class IIa in Europe may have a completely different classification in the USA or China – with corresponding effects on timelines, budgets and study requirements.
There are also practical hurdles: Many countries require a local representative or registration agent on site. Communication with authorities is often exclusively in the local language, technical standards deviate from international standards, and even the labeling requirements for UDI or instructions for use vary considerably. Companies also report unclear requirements that only become clear during the approval process, as well as high ongoing costs for re-registrations and change notifications.
BAYOOCARE meets these challenges with structured processes, detailed preliminary research and an international network of qualified partners. This allows you to avoid costly delays and keep control of the schedule and budget.
Market analysis and approval strategy
We analyze the regulatory situation in your target markets: Is your product classified as a medical device there? Which risk class is likely to apply and which approval route is most suitable? We realistically estimate initial and follow-up costs and develop a concrete approval roadmap with milestones, responsibilities and timeframes.
Regulatory intelligence per target country
We systematically identify all relevant laws, regulations and standards for each target country and determine the specific documentation, format and language requirements of the relevant authorities. We clarify country-specific features – such as cybersecurity, radio modules or country-specific testing requirements – at an early stage. This regulatory intelligence forms the basis for all further steps.
Local representatives and approval partners
In most markets – from the USA and Australia to Saudi Arabia and South Korea – a local representative is required by law. We support you in selecting suitable partners, clarify contractual regulations on document access and market surveillance obligations and ensure that you as a manufacturer retain control over your approvals.
Long-term registration maintenance and post-market support
After successful initial registration, we organize the systematic maintenance of your registrations: Re-registrations, certificate renewals and change notifications for product modifications. We support the implementation of vigilance notifications and recall processes in accordance with the respective country-specific requirements. Through continuous regulatory intelligence, we keep you up to date on relevant changes in your target markets.
Technical documentation and submission to authorities
We create your technical documentation in internationally recognized formats – STED, CSTD or IMDRF Table of Contents – and use a modular approach to reuse core documents for multiple markets. We coordinate translations of critical content with validation to avoid misinterpretation by authorities. We take full responsibility for submissions to the FDA, TGA, Health Canada, NMPA and other national regulatory authorities – including query management and audit preparation. Where possible, we use existing certificates – CE, FDA clearance or MDSAP – as the basis for shortened procedures.
We work with you to develop an individual launch strategy and create a concept with trend analyses and correct classification of the product classification. The classification of software medical devices according to Rule 11 of the MDR is particularly critical, as the risk class determines which conformity assessment procedure must be undergone. We analyze your intended purpose, evaluate the risk profile and define the optimal MDR compliance strategy for your target markets.
We specialize in regulatory, clinical and quality requirements in the MedTech environment – with a clear focus on international market access. What sets us apart is speed: thanks to structured processes, reusable documentation formats and close coordination with authorities, we realize approvals significantly faster than the industry average. Precise preliminary research and consistent frontloading of all critical points prevent months of delays due to incomplete documents or unclear requirements. Where other service providers only come across country-specific peculiarities during the ongoing process, we have already identified and addressed these in the planning phase.
We have in-depth experience with approval strategies and technical documentation for several target regions – from EU MDR and IVDR to FDA procedures and Asian, Latin American and Middle Eastern markets. We rely on an established network of international experts, accredited test laboratories and local representatives.
Our approach is geared towards sustainability: We don’t just look at the initial registration, but at the entire product life cycle – including post-market surveillance, re-registrations and ongoing compliance. This protects your investment in market access in the long term.
