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Research on International Market Regulations and Registration Policies:
For the target markets designated by the company (such as the EU, the US, and various countries in Asia), systematically sort out the registration regulations, technical standards (such as FDA, MDR quality management system requirements, IEC 60601-2-1 product requirements, etc.), approval processes, and timelines for radiotherapy products. Analyze the dynamics and trends of registration policies in target markets, identify potential regulatory risks (such as upgrades in technical review requirements, changes in compliance inspection frequency, etc.), and provide risk response recommendations.
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Registration Strategy and Path Planning:
Based on the company's product technical characteristics, target market competition landscape, and customer needs, develop a differentiated international registration layout plan, clarifying registration priorities, timelines, and resource allocation plans for each market.
For multi-market simultaneous registration scenarios, provide suggestions for optimizing registration process coordination, avoiding duplicate work, and improving overall registration efficiency (such as sharing some technical documents and coordinating testing and certification timelines).
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Registration Document Preparation and Technical Support:
Guide or assist the company in preparing registration documents required for target markets, including but not limited to technical documents (such as product specifications, risk management reports, clinical evaluation reports), quality management system documents, application forms, etc., ensuring documents comply with local regulatory requirements and format standards.
Assist in technical communication during the registration process, such as providing professional response plans for review opinions raised by regulatory authorities; assist in organizing technical review meetings and answering questions during the review process.
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Registration Implementation and Problem Solving:
Track the registration progress in each target market in real time, regularly submit progress reports to the company, and promptly feedback abnormal situations during the registration process.
Provide professional solutions for problems encountered during registration (such as document corrections, supplementary testing items, adjustments to clinical data requirements, etc.) to promote smooth registration progress.
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Subsequent Compliance Support:
After registration is completed, provide suggestions for subsequent compliance maintenance in target markets, including product change registration, annual report submission, and compliance adjustments after regulatory updates.
Assist the company in conducting employee training related to registration, enhancing the internal team's understanding of international registration regulations and processes.
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