The NMPA National Institutes for Food and Drug Control released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process” on August 21, 2025 for feedback. Feedbacks need to be submitted by September 20, 2025.
This draft represents the Chinese adoption of ISO/FDIS 10993-1:2025, aligning with internationally recognized framework for biological safety evaluation of medical devices.
The main theme of the update is to avoid unnecessary biological testing and instead to evaluate safety using a risk management approach that incorporates multiple types of evidence, including chemical characterization, toxicological risk assessment, and scientific comparison with existing products.
For key points to navigate the biological evaluation of Class III medical devices, please click HERE
Alignment with ISO Standards
One of the most notable aspects of this update is its timing. Typically, Chinese GB/T or YY medical device standards are revised after ISO standards are officially published, often with a delay of one to several years. For example, the 2022 version of GB/T 16886.1 lagged behind the corresponding ISO revisions.
This time, however, the GB/T standard is being revised in parallel with ISO. ISO 10993-1:2025 entered the “Under Publication” stage on July 18, 2025, meaning it would be formally released by October 5, 2025. The official project plan for GB/T 16886.1-2025 also targets October 2025 for final review, ensuring that the Chinese standard and the ISO version will be issued simultaneously.
This represents a significant policy shift. By maintaining alignment with ISO timelines, China demonstrates commitment to global harmonization of medical device regulations. For multinational manufacturers, this reduces the regulatory gap between global and Chinese requirements, streamlining product development and submission strategies.
A New Evaluation Pathway: Biological Equivalence
The 2025 draft introduces a new formal concept: biological equivalence.
Traditionally, biological evaluation relied heavily on direct testing — cytotoxicity, irritation, sensitization, systemic toxicity, and so on. While alternative approaches such as chemical characterization were gradually recognized, there was no structured pathway to waive testing.
The new draft fully embeds the ISO 14971 risk management process into biological evaluation. Instead of passive reliance on tests, manufacturers are encouraged to proactively control risks. Within this framework, biological equivalence becomes a legitimate pathway to demonstrate safety.
Biological equivalence requires evidence of:
- Material equivalence — the same type and grade of material.
- Contact equivalence — the same tissue/organ contact and duration of exposure.
- Process equivalence — the same manufacturing, processing, and sterilization methods.
If equivalence can be scientifically demonstrated, part or all of the biological testing may be waived.
Example: An orthopedic implant made of titanium alloy (ASTM F136), with the same surface treatment and ethylene oxide sterilization as an existing marketed device, and used in the same anatomical site (bone) with the same exposure duration (permanent implantation), can claim biological equivalence.
This approach mirrors global practices, such as FDA’s exemption pathways for certain dental and orthopedic implants. It encourages scientific reasoning over repetitive testing, reducing animal use and accelerating innovation.
Major Conceptual Adjustments
- Systemic Toxicity
In the 2022 version, “systemic toxicity” referred specifically to acute systemic toxicity. The new draft broadens the definition to cover acute, sub-acute, sub-chronic, and chronic systemic toxicity, collectively called comprehensive systemic toxicity.
At first glance, this expansion may appear confusing: manufacturers may wonder which type of toxicity they must evaluate. However, the intent is not to create more mandatory tests, but to provide flexibility. The draft explicitly states that it is not necessary to conduct separate studies for each toxicity category.
Importantly, for the first time, the standard clarifies that toxicological risk assessment using chemical characterization data may be used to evaluate systemic toxicity. This means that if chemical analysis shows that leachable substances are below toxicologically relevant thresholds, systemic toxicity testing may be waived.
This shift reflects modern regulatory science: a move away from blanket animal testing toward a science-based, risk-informed evaluation.
- Nature of Contact
The current standard categorizes device–body contact into eight types. The 2025 draft simplifies this to four “contact natures”, and reorganizes the biological evaluation matrix accordingly.
Rather than using a single comprehensive evaluation table, the draft provides separate smaller tables aligned with each contact nature. This restructuring makes classification clearer, reduces redundancy, and helps manufacturers better match devices to appropriate evaluation requirements.
Testing Requirement Updates
- Intact Skin — Irritation
For short-term intact skin contact devices (e.g., disposable examination pads), the requirement is now stricter. Previously, only two biological tests were required, and irritation testing could be omitted. The new draft mandates irritation evaluation, aligning Chinese requirements with ISO’s “three core tests” (cytotoxicity, sensitization, irritation).
- Intact Mucosa — Genotoxicity
For devices with non-short-term mucosal contact, genotoxicity testing is now required. This ensures that long-term mucosal contact devices undergo a deeper safety assessment, given the sensitivity of mucosal tissues.
- Blood — Implantation Response
For devices in short-term blood contact, the requirement to evaluate implantation response has been removed. The reasoning is that current provisions already address externally communicating devices such as guidewires and catheters. The update streamlines requirements and eliminates the outdated concept of “externally communicating devices.”
Implications for Industry
The GB/T 16886.1-2025 draft reflects several broader trends in medical device regulation:
- NMPA emphasizes more on risk management and toxicological reasoning, reducing reliance on mechanical testing
- Alignment with ISO makes global regulatory submissions more consistent
- By promoting chemical characterization and equivalence arguments, the standard supports the global “3Rs” principle (replacement, reduction, refinement of animal testing) and reduces animal testing
- Manufacturers can better plan biological evaluation strategies, knowing that China’s requirements will not lag significantly behind ISO, which increases regulatory predictability.