On March 16, 2026, the Taiwan Food and Drug Administration (TFDA) issued three new guidance documents setting out pre-clinical testing requirements for Bone Anchors, Liquid Chemical Sterilants/High-Level Disinfectants, and Repetitive Transcranial Magnetic Stimulation (rTMS) Systems. These guidance documents establish standardized frameworks for evaluating product safety and performance and are intended to support more consistent regulatory submissions and technical review.
Key Highlights:
- Guidance for Pre-clinical Testing of Bone Anchor
- Scope
This guideline covers orthopedic bone anchor systems used to reattach soft tissue (tendons and ligaments) to bone. The system consists of an Anchor and a Suture, made from metal or polymers such as absorbable (PLLA) or non-absorbable (PEEK) materials. This scope includes All suture anchor systems but excludes bone-to-bone internal fixation devices and artificial ligaments or tendons. - Regulation number and Identification:
- N.3030, Single/multiple component metallic bone fixation appliance and accessories
- N.3040, Smooth or threaded metallic bone fixation fastener
- Pre-clinical Information and Data Required:
- Product description and specification, including components, dimensions, material composition, assembly, operation, and additional specifications (e.g., surface treatments such as Coating, Etch).
- Safety and performance data, including biocompatibility, sterilization, suture property evaluation, performance (mechanical and physicochemical properties), shelf-life, stability, and magnetic resonance compatibility.
- Scope
- Guidance for Pre-clinical Testing of Liquid Chemical Sterilants/High Level Disinfectants
- Scope
This guideline applies to liquid chemical sterilants and high-level disinfectants used for critical and semicritical medical devices. Critical devices are those that contact sterile body tissues or areas, while semicritical devices contact mucous membranes or non-intact skin. This Scope excludes sterilants used with sterilization systems and chemical disinfectants for contact lenses. - Regulation number and Identification
J.6885, Liquid chemical sterilants/ high level disinfectants - Pre-clinical Information and Data Required:
- Product Configuration and Composition Description
- Mechanism and Efficacy
- Operation and Compatibility
- Safety and performance data, including safety, biocompatibility, performance, effective concentration tests, stability and compatibility tests.
- Scope
- Guidance for Pre-clinical Testing of Repetitive Transcranial Magnetic Stimulation (rTMS) Systems
- Scope
Applies to medical devices that utilize alternating magnetic fields to non-invasively stimulate specific areas of the brain for therapeutic purposes (e.g., treatment of depression). - Regulation number and Identification
K.5805, Repetitive transcranial magnetic stimulation system - Pre-clinical Information and Data Required:
- System Components and Structure,
- Stimulation Parameters and Magnetic Characteristics,
- Safety Functions and Thermal Limits,
- Treatment Procedures and Indications, and
- Safety and performance data, including biocompatibility, electrical safety, performance, magnetic field validation, safety functions, device compatibility, and clinical risk assessment.
- Scope
For further details, please refer to the official TFDA announcement and guidance documents below.
- TFDA Announcement No. 1151601807 (Traditional Chinese only)
- Guidance for Pre-clinical Testing of Bone Anchor
- Guidance for Pre-clinical Testing of Liquid Chemical Sterilants/High Level Disinfectants
- Guidance for Pre-clinical Testing of Repetitive Transcranial Magnetic Stimulation (rTMS) Systems
Implications to Clients
- Harmonization with International Standards: These TFDA guidance documents are closely aligned with international standards (such as ISO and US FDA guidance). We strongly encourage clients to read the full text of the TFDA announcements and the reference documents in detail. Leveraging these resources will ensure that the product’s safety and efficacy data are robust enough to meet both clinical needs and regulatory compliance.
- Immediate Compliance Alignment: As these guidelines take effect immediately, manufacturers must ensure that all new registration applications for bone anchors, liquid sterilants, and rTMS systems adhere to the newly standardized testing frameworks and documentation requirements.
- Gap Analysis for Ongoing Projects: For products currently in the development or clinical trial phase, a gap analysis is recommended to identify any missing pre-clinical data, such as magnetic resonance compatibility for bone anchors or magnetic field spatial distribution for rTMS, to avoid potential delays during the technical review.
Effectivity Date
The guidance documents took effect immediately upon issuance.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Taiwan, please contact info@nordpacificmed.com