Medical Devices
Medical device manufacturers in Australia seeking to enter the Liechtenstein market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Office of Public Health oversees medical device regulation in Liechtenstein, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.
Taylored Consultancy provides complete medical device regulatory support for Australia companies expanding to Liechtenstein. Our services include device classification, technical file preparation, clinical evaluation, UK Responsible Person (UKRP) or EC Representative (EC-REP) services, and ongoing post-market surveillance to ensure full compliance throughout your product lifecycle.
Comprehensive risk classification under Liechtenstein medical device regulations, conformity assessment pathway determination, and regulatory strategy development.
Complete registration process with Office of Public Health, including dossier preparation, technical documentation, submission management, and authority liaison for approval.
We act as your authorized representative in Liechtenstein, handling regulatory communications, maintaining compliance documentation, and managing authority interactions.
Complete technical file preparation including device description, design verification, risk management, clinical evaluation, and manufacturing documentation for Liechtenstein.
ISO 13485 quality management system verification, manufacturing evidence compilation, GMP compliance documentation, and quality assurance systems for Liechtenstein approval.
Conformity certificates, import licenses, market authorization applications, and ongoing post-market surveillance requirements for successful Liechtenstein market entry.
