Challenges
Many Swiss companies need their own regulatory team to manage the various market entry barriers in Asia
How do we ensure that we work in accordance with the dynamic local legislation? Who continuously ensures that we adapt our labeling obligations to legal updates?
Our Regulatory Services – Your added value
With ADMELIORA®, you benefit from a well-coordinated team of regulatory affairs professionals with strong relationships to the Chinese government
We guarantee you smooth processes and thorough assessments with multiple second opinions. Thanks to the collaboration with ADMELIORA®, you benefit from:
Clinical Studies and Tests
Conduct high-quality clinical studies and tests in China at affordable prices
Biocompatibility Testing according to ISO 10993
Testing the biological compatibility of materials, e.g., cytotoxicity, sensitization, irritation.
Complex, costly tests that require animal studies and specialized laboratory equipment.
Sterility Testing according to ISO 11135 and ISO 11137
Validation of sterilization methods (e.g., EO, gamma), sterility testing, endotoxin testing (LAL).
Need for special cleanrooms and long-term validations.
Packaging Testing according to ISO 11607
Testing of medical device packaging, e.g., seal integrity, stability under storage conditions.
Requirement for specific testing methods and machines (e.g., for seal integrity, aging).
EMC Testing according to IEC 60601-1-2
Testing the electromagnetic compatibility of devices (emissions and immunity).
Need for EMC chambers and certified testing facilities, which are expensive and highly specialized.
Toxicological Testing according to ISO 10993 and USP
Testing the toxicity of materials and products.
Required laboratory equipment and animal studies that must be conducted externally.
Storage Tests / Accelerated Aging according to ASTM F1980 and ISO 11607
Aging tests under accelerated conditions to assess shelf life and stability.
Long testing durations and specialized test benches needed, expensive.
Material Analysis (Extractables & Leachables) according to ISO 10993-18
Testing for extractable substances and potential toxic leachables from materials.
Required chemical laboratory technologies such as GC-MS or LC-MS.
Implantation Testing according to ISO 10993-6
Long-term testing of implantable medical devices to assess tissue compatibility.
Requires animal studies and specialized laboratories.
Certification and Consulting for Quality Management according to ISO 13485
Consulting and support for the implementation of quality management systems (QMS).
External expertise needed to meet regulatory requirements and certify QMS.
Mechanical Testing according to ISO 60601 and ISO 11607
Tensile, bending, torsion tests, accelerated aging, and transportation simulation.
High costs for specialized tests and test benches, expensive infrastructure (climate chambers, vibration testing).
