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The Regulatory Challenge of Allografts in Peru – medical professionals working in a laboratory

The Regulatory Challenge of Allografts in Peru

An allograft is human tissue donated by one person for implantation into another genetically distinct individual. Its processing is carried out by tissue banks or biotechnology companies in strict compliance with procedures designed to ensure its quality, safety, preservation, and traceability prior to implantation into another person through a surgical procedure.

Due to its unique biological nature, an allograft does not conform to a predetermined design and does not have a manufacturer in the traditional sense. However, in Peru, in the absence of a specific legal classification, allografts are subject to regulatory requirements designed for manufactured products. They are assessed under the regulatory framework applicable to medical devices and are therefore subject to the regime established by Law No. 29459, the Law on Pharmaceutical Products, Medical Devices, and Sanitary Products, and its implementing regulations approved by Supreme Decree No. 016-2011-SA, as amended.

In practice, this means that applicants seeking marketing authorizations for allografts in Peru must comply with the local documentary requirements applicable to medical devices, even when the documentation accompanying these products from abroad has been issued in jurisdictions with a distinct regulatory classification, where assessment and control requirements differ from those established for conventional medical devices.

This is not a matter of insufficient oversight, but rather a mismatch between the regulatory framework and the specific nature of these products.

What measures should the health sector adopt to ensure a coherent regulatory framework for allografts?

  • Establish a specific category and authorization pathway for allografts, based on tissue type, processing methods, and intended use, aligned with regulations governing human tissue donation and transplantation.
  • Implement technical standards to ensure traceability of human tissue from donation to implantation in the patient, strengthening donor assessment, processing and preservation controls, and post-implantation surveillance.
  • Promote awareness and the appropriate, informed use of allografts among healthcare professionals and patients, in accordance with their indications and the available evidence regarding their benefits and risks.

We believe that improving the regulatory framework for allografts requires recognizing their distinctive nature and their social, ethical, and medical dimensions by establishing a specific category and an authorization pathway tailored to their characteristics and risks. This would help make administrative procedures more predictable and facilitate timely access to this treatment option, while maintaining the necessary quality and safety safeguards.