Regulatory Affairs & Registration
Requirements for the registration and marketing of cosmetics and medical devices vary from market to market and are becoming increasingly complex. With extensive experience and an international customer base, MEDENA understands the diverse regulatory requirements worldwide and supports you in meeting them reliably and correctly. We assist with the preparation, management and provision of the required documentation, helping you bring your products to market efficiently and in compliance with applicable regulations.
Our Service Portfolio
MEDENA supports customers with regulatory matters relating to cosmetics, medical devices and certifications. You benefit from close collaboration between development, quality management, manufacturing and regulatory affairs.
Cosmetic Products
For cosmetic products, we support the preparation, management and provision of all relevant documentation for product registration and marketing.
Our services include:
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Preparation and maintenance of Product Information Files (PIFs / cosmetic dossiers)
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Compilation of product documentation relevant to registration
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Support for cosmetics GMP-compliant manufacturing in accordance with ISO 22716:2007
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Organisation of stability testing
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Support for dermatological efficacy and tolerance testing
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Management of product-specific documentation for national and international markets
Medical Devices
For non-sterile medical devices, we support the preparation of the required technical documentation in accordance with applicable regulatory requirements.
This includes:
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Advice on product classification and categorisation
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Support in preparing technical documentation
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Risk analyses
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Labelling requirements
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Documentation requirements in accordance with ISO 13485:2016
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Support for product-specific testing and evidence
Labelling & Claims Review
Legally compliant product labelling is essential for a successful market launch.
MEDENA provides support with:
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Review of INCI declarations
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Review of packaging artwork
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Assessment of product claims
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Review of statutory labelling requirements
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Advice on product claims and advertising statements
International Registrations
For distribution in international markets, we support the preparation and provision of the necessary documents and evidence.
These include:
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Certificates of Free Sale
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Manufacturer declarations
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Product documentation
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Notarial certifications
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Apostilles
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Market-specific registration documents
Your Partner for Regulatory Requirements
From product documentation and certifications to international registrations, MEDENA supports customers with regulatory requirements throughout the product lifecycle.
Our experience in development, quality management and manufacturing provides a solid foundation for efficient, compliant and successful market launches, both nationally and internationally.
