Before entering the market, medical products must pass regulatory review. The technical documentation required for certification—such as test reports—must be produced by impartial, professional third-party laboratories to demonstrate product safety and effectiveness.

Shen Hsin-Wei, Senior Manager of Medical Affairs, BE Health Ventures

Third-party laboratories themselves must obtain accreditation and undergo regular audits to ensure quality—for example, ILAC, TAF, A2LA, GLP, depending on the laboratory’s scope. According to the International Organization for Standardization (ISO), laboratory accreditation is a formal recognition that a laboratory is competent to carry out specific tests or calibrations. When selecting a third-party lab, you should ask for proof of accreditation to verify that its workflows, personnel, and equipment are properly controlled and that it is competent to perform the claimed testing activities.

TAF — Taiwan Accreditation Foundation

In Taiwan, TAF accreditation is the most common for electrical safety laboratories, aligned with the conformity standard ISO/IEC 17025. TAF (Taiwan Accreditation Foundation) accredits testing laboratories as an impartial body. Reports issued by TAF-accredited labs are recognized as meeting conformity requirements and are broadly accepted domestically and internationally. ISO/IEC 17025 covers competence for testing and calibration laboratories, governing operational capability and test validity to ensure credibility of results.

Eurofins E&E — MET Safety Laboratories

Eurofins E&E–MET provides testing for medical products, laboratory and measurement equipment, IT products, outdoor equipment (IP & NEMA), primary and secondary lithium and NiMH batteries, North American appliances and luminaires, and reliability tests (temperature, salt spray, vibration, shock, etc.).
For medical products, the lab offers a wide range of evaluations—including general medical electrical equipment, home healthcare environment devices, EMS (emergency medical services environment) equipment, IVD, endoscopes, ECG devices, laser/optical medical equipment, TENS devices, blood pressure monitors, pulse oximeters, blood glucose monitoring systems, operating tables, surgical/diagnostic luminaires, and medical beds—and holds TAF accreditation for these scopes. For the U.S. market, MET also supports the FDA’s ASCA Program, which is less common in Taiwan.

FDA ASCA Program

The ASCA (Accreditation Scheme for Conformity Assessment) is an FDA initiative to expedite premarket review. Based on international consensus standards and FDA-recognized ASCA program specifications, the FDA grants ASCA recognition to qualified testing laboratories. Manufacturers may choose ASCA-recognized labs to test products intended for FDA submissions; such testing is conducted in accordance with ASCA procedures. As noted above, Eurofins E&E (MET) has obtained FDA ASCA recognition and can help medical device manufacturers targeting the U.S. market streamline FDA application timelines.

For investors and startup teams in biomedical products, independent third-party laboratories provide objective, critical information that builds confidence in a product’s safety and effectiveness, and clarifies whether its regulatory pathway is well-planned.

For more information, please contact: Joseph.Shen@be.tworg.app