Supervising tissue establishments
- Permit or other obligation
- Nationwide
- Public service
Fimea directs and supervises the activities of tissue establishments in Finland (Act 101/2001 on the Medical Use of Human Organs and Tissues ("Tissue Act"), Section 20 j) and collaborates with the relevant international authorities.
The purpose of tissue legislation is to ensure the quality and safety of human tissues and cells intended for use in humans. Implementation of quality and safety requ ...
Do the following
The requirements relating to the activities of tissue establishments include the following:
• Tissue establishments must be licensed by Fimea.
• Tissue establishments must have an appointed responsible person to see that the activities comply with the applicable laws.
• The personnel of tissue establishments must be appropriately qualified, and regular training must be arranged.
• Tissue establishments must have an up-to-date quality system that is based on Good Practice.
• Tissue establishments must have a system to implement the traceability of cells and tissues.
• Tissue establishments must keep a registry of adverse effects and hazardous situations related to tissues and cells. However, the duty to report to Fimea only applies to serious adverse effects and hazardous situations.
• If a tissue establishment commissions with Fimea's permission a third party for individual tasks, the tissue establishment must have a written contract with the party in question.
• The tissue establishment must keep a registry of its activities and store any data necessary for traceability requirements for at least 30 years after clinical use.
Fimea provides on request guidance and advice on how to apply regulations concerning tissue establishment activities.
To whom and on what terms
The requirements relating to the activities of tissue establishments include the following:
• Tissue establishments must be licensed by Fimea.
• Tissue establishments must have an appointed responsible person to see that the activities comply with the applicable laws.
• The personnel of tissue establishments must be appropriately qualified, and regular training must be arranged.
• Tissue establishments must have an up-to-date quality system that is based on Good Practice.
• Tissue establishments must have a system to implement the traceability of cells and tissues.
• Tissue establishments must keep a registry of adverse effects and hazardous situations related to tissues and cells. However, the duty to report to Fimea only applies to serious adverse effects and hazardous situations.
• If a tissue establishment commissions with Fimea's permission a third party for individual tasks, the tissue establishment must have a written contract with the party in question.
• The tissue establishment must keep a registry of its activities and store any data necessary for traceability requirements for at least 30 years after clinical use.
Fimea provides on request guidance and advice on how to apply regulations concerning tissue establishment activities.