On January 28, 2026, the Taiwan Food and Drug Administration (TFDA) announced the issuance of the Safety Evaluation Reference Documents for Medical Devices Containing Materials Derived from Animal Sources, together with related Frequently Asked Questions (FAQ). This guidance establishes safety evaluation principles and documentation expectations for medical devices that incorporate non-viable animal tissues or their derivatives as raw materials.
Scope
The guidance applies to medical devices that contain, or are manufactured using, non-viable animal tissues and their derivatives (e.g., bovine bone, porcine collagen).
The scope excludes:
- In Vitro Diagnostic Medical Devices (IVDs)
- Materials derived from human sources
Background
To strengthen the control of potential zoonotic and transmissible spongiform encephalopathy (TSE) risks associated with animal-derived materials, TFDA has issued this reference document to clarify:
- Safety evaluation principles for animal-derived raw materials
- Risk management expectations aligned with international standards
- Regulatory submission documentation requirements
The guidance aligns with internationally recognized standards, including ISO 14971 and the ISO 22442 series, and aims to ensure manufacturers can demonstrate acceptable residual risk throughout the device lifecycle.
Keypoints
- Manufacturers must conduct comprehensive risk management for animal-derived materials used in medical devices.
- Risk identification and control shall consider tissue characteristics, animal species, geographical origin, sourcing controls, and contamination risks.
- Safety evaluations must address risks related to pathogens, pyrogenicity, immunogenicity, toxicity, TSE, and cross-contamination.
- Residual risks must be justified against the intended benefits of the medical device; alternative materials should be considered if risks are unacceptable.
- Additional and more stringent requirements apply to TSE-risk species, including bovine, ovine, and caprine sources.
Risk Management Requirements
Manufacturers are expected to:
- Identify safety features, hazards, and hazardous situations associated with:
- Device–body contact characteristics
- Animal species and tissue type
- Country and region of origin
- Device supply status
- Collection, processing, storage, and transport conditions
- Evaluate risks of:
- Viral and bacterial pathogens
- Pyrogenicity and immunogenicity
- Toxicity and cross-contamination
- TSE transmission
- Apply relevant international standards, including:
- ISO 14971 (Risk Management)
- ISO 22442 series (Animal Tissues and Their Derivatives)
- Applicable ISO sterilization and ISO 10993 biocompatibility standards
Data System Requirements
Manufacturers must establish and maintain systems to:
- Track zoonotic disease status and epidemiological changes
- Maintain historical records of animal raw material sourcing
- Monitor and document changes in sourcing, processing, or risk profiles over time
TSE-Specific Requirements
For materials derived from bovine, ovine, or caprine sources, manufacturers must additionally:
- Evaluate:
- Country BSE status
- Animal age and herd management practices
- Feed history and tissue infectivity
- Prevent cross-contamination during:
- Slaughter
- Collection
- Processing
- Transport
- Validate TSE inactivation or elimination processes in accordance with ISO 22442-3
Required Submission Documents
Regulatory submissions to TFDA should include, as applicable:
- Risk analysis and risk control report
- Animal sourcing and origin evidence
- Records of collection, processing, storage, and transport
- Validation data for pathogen and virus inactivation
- Additional TSE-related documentation for bovine/ovine/caprine materials, including:
- BSE status
- Animal age and herd history
- Slaughter and processing procedures
- Traceability documentation
- TSE Elimination/Inactivation verification
Implications to Clients
Manufacturers using animal-derived materials should ensure compliance with this guidance. Key considerations include:
- Implementing robust risk management systems aligned with ISO 14971 and ISO 22442
- Strengthening supplier qualification, traceability, and sourcing controls
- Conducting validated virus and TSE inactivation studies or providing well-justified literature-based evidence
- Maintaining comprehensive and well-organized documentation for TFDA regulatory submissions
Manufacturers utilizing bovine, ovine, or caprine materials will face heightened compliance requirements, particularly related to BSE risk controls and traceability. Early compliance during R&D stage is critical to avoid delays in TFDA review and approval.
Effective Date
This guidance takes immediate effect.
References
TFDA Announcement No. 1151600422 (Traditional Chinese only)
For the official TFDA announcement and legal notice, please refer to this document: TFDA Announcement No. 1151600422 (Traditional Chinese only)
Safety Evaluation Reference Documents for Medical Devices Containing Materials Derived from Animal Sources
For detailed safety evaluation requirements, risk management principles, and documentation expectations, please refer to this document: Safety Evaluation Reference Documents for Medical Devices Containing Materials Derived from Animal Sources
FAQ on Safety Evaluation for Animal-Derived Materials For clarifications on scope, interpretation of requirements, and common implementation questions, please refer to this document: FAQ
Next Steps
Should you require assistance in assessing compliance, preparing risk management documentation, or supporting TFDA submissions, our regulatory team is available to assist.
Contact us at info@nordpacificmed.com or click the button below for more details.