Medical Devices
Medical device manufacturers in Australia seeking to enter the Serbia market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Medicines and Medical Devices Agency of Serbia (ALIMS) oversees medical device regulation in Serbia, 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 Serbia. 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 Serbia medical device regulations, conformity assessment pathway determination, and regulatory strategy development.
Complete registration process with Medicines and Medical Devices Agency of Serbia (ALIMS), including dossier preparation, technical documentation, submission management, and authority liaison for approval.
We act as your authorized representative in Serbia, 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 Serbia.
ISO 13485 quality management system verification, manufacturing evidence compilation, GMP compliance documentation, and quality assurance systems for Serbia approval.
Conformity certificates, import licenses, market authorization applications, and ongoing post-market surveillance requirements for successful Serbia market entry.
