Human Tissue Authority

The regulator for human tissue and organs

This document is designed to provide you with information about the Human Tissue Authority (HTA) inspection process, so that you and your staff can prepare for an HTA inspection.• There is a first part of this guidance, covering general inspection information• The appendix - applicable to both parts one and two - can be downloaded here• The whole document - parts one and two, plus the appendix -...
The standards that establishments licensed under an HTA anatomy licence should meet
  • HTA standards
  • Licensing
Guidance on paragraphs 194-196 of the HTA’s Code of Practice on the Human Transplantation (Wales) Act 2013 - Persons who Lack Capacity to Consent
  • Deceased donation
  • Wales
Consent
  • Codes of practice
  • Licensing
The standards that establishments licensed under an HTA post mortem licence should meet
  • HTA standards
  • Licensing
New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.The scope of the MDR now includes certain products manufactured utilising derivatives of tissues or cells of...
  • Advanced Therapy Medicinal Products
  • EU tissue and cells directive
  • Human application
  • Public display
What satellite premises are and who is responsible for managing any HTA-licensed satellite premises.
  • General licensing
  • Licensing
This page provides background information on the implementation of the EU Tissue and Cells Directive via the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
  • EU tissue and cells directive
This document is designed to provide you with information about the Human Tissue Authority (HTA) inspection process, so that you and your staff can prepare for an HTA inspection.• There is a second part of this guidance, covering site visits• The appendix - applicable to both parts one and two - can be downloaded here• The whole document - parts one and two, plus the appendix - can be downloaded...

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