Regulatory Open Forum

I'm wondering if any of you may be aware of the appropriate regulations related to importing/exporting human tissues to/from Brazil for the purposes of a commercial tissue bank? Thanks for any pointers to regulations on this topic within ANVISA or elsewhere for Brazil/US commercial collaborations.
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Hi, ANVISA and MoH have equal role in regulating the import/export of human tissues to/from Brazil. The commercial tissue bank must obtain authorization, must obtain permits and other required documentation for the import or export of human tissues from the appropriate Brazilian authorities, such as the Brazilian Customs and the Brazilian Federal Police. The commercial tissue bank must ensure the traceability of human tissues from the donor to the recipient, using appropriate labeling and documentation procedures. The commercial tissue bank must comply with ANVISA and MoH standards for the quality and safety of human tissues intended for transplantation, including standards for tissue processing, storage, and testing. The commercial tissue bank must adhere to ethical and legal standards for tissue donation and transplantation, including obtaining informed consent from donors and ensuring that tissues are not procured through coercion or financial incentives. The human tissues must be cleared through Brazilian Customs, which may involve inspections and additional documentation requirements. The commercial tissue bank is subject to monitoring and inspection by ANVISA and the MoH to ensure compliance with all applicable regulations and requirements.

I'm wondering if any of you may be aware of the appropriate regulations related to importing/exporting human tissues to/from Brazil for the purposes of a commercial tissue bank? Thanks for any pointers to regulations on this topic within ANVISA or elsewhere for Brazil/US commercial collaborations.
<o:p></o:p>

I'm wondering if any of you may be aware of the appropriate regulations related to importing/exporting human tissues to/from Brazil for the purposes of a commercial tissue bank? Thanks for any pointers to regulations on this topic within ANVISA or elsewhere for Brazil/US commercial collaborations.
<o:p></o:p>

The Blood, Tissues, Cells and Organs Management of the National Health Surveillance Agency (GSTCO/Anvisa), in partnership with the General Coordination of the National Transplant System of the Ministry da Saúde (CGSNT/MS), provides 4 (four) forms for Tissue Banks to inform their production data, complying with the provisions of art. 165 of the Resolution of the Collegiate Board - RDC Anvisa # 55/2015, which provides for Good Practices in human tissues for therapeutic use. Imports of tissue banks regulation is RDC 81/08  https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2008/rdc0081_05_11_2008.pdf (in portuguese). I hope this helps.

I'm wondering if any of you may be aware of the appropriate regulations related to importing/exporting human tissues to/from Brazil for the purposes of a commercial tissue bank? Thanks for any pointers to regulations on this topic within ANVISA or elsewhere for Brazil/US commercial collaborations.
<o:p></o:p>