Regulatory Update: Taiwan

Strengthening Compliance: Taiwan Releases Preclinical Testing Standards for Key Medical Devices

In a move to enhance regulatory clarity and support medical innovation, Taiwan’s Medical Devices and Cosmetics Group announced the release of preclinical testing standards for two device categories: assisted reproductive catheters and fixed diagnostic X-ray systems. The announcement, made on April 10, 2025, under Article 165 of the Administrative Procedure Act, provides manufacturers with essential guidance to navigate the country’s evolving regulatory landscape.

Key Highlights of the New Standards

The newly published standards outline critical preclinical testing parameters that manufacturers must consider when developing these devices and preparing regulatory submissions. By defining expectations for safety and performance, the guidance ensures consistency across evaluations and supports timely and efficient product approvals.

These standards serve as an official reference point for:

• Ensuring device safety and efficacy through structured preclinical evaluation

• Supporting the preparation of technical documentation for regulatory submissions

• Reducing ambiguity and enhancing predictability in the approval process

Why This Matters for Medical Device Manufacturers

As Taiwan continues to strengthen its regulatory framework, the publication of device-specific testing standards marks a strategic step toward aligning with global best practices. For international manufacturers aiming to access the Taiwanese market, these guidelines provide a valuable roadmap for aligning product development with local compliance expectations.

Staying ahead of evolving standards is crucial. Understanding the technical and procedural implications of such updates can significantly impact your device’s time to market and regulatory success.

Arazy Group: Your Trusted Partner for Taiwan Market Access

Successfully registering medical devices in Taiwan requires more than product quality—it demands regulatory precision. With over 25 years of experience supporting manufacturers in over 140 countries, Arazy Group offers tailored solutions to help you navigate Taiwan’s medical device registration process with confidence.

Our expertise includes:

• Strategic guidance on documentation aligned with Taiwan’s new testing standards
• Comprehensive support for preclinical evaluation planning
• Management of end-to-end registration submissions

Accelerate Your Entry into the Taiwanese Market

If your company is preparing to register assisted reproductive catheters or diagnostic X-ray systems in Taiwan, Arazy Group is here to support your regulatory journey. Let us help you ensure full compliance and smooth market entry in one of Asia’s most promising healthcare markets.

Connect with us today to learn how our global regulatory expertise can drive your success in Taiwan and beyond.

For further details, you can access the full guideline here: FDA Guideline.