Taiwan Adds a Conditional Rework Route for Recalled Imported Devices

Taiwan has added a supervised rework route for certain recalled imported medical devices whose Chinese labelling was applied domestically. The Ministry of Health and Welfare's order of 10 September 2026, 衛授食字第1151604557號, amends Articles 4 and 14 of the Regulations for Medical Device Recalls.

The change is limited to the disposition of recalled products meeting the new conditions. It does not give every importer a choice between rework and re-export.

Publication and legal effect are different dates

The final ministerial order was published on 10 September 2026. Amended Article 14 uses the commencement wording “from the date of promulgation”. Under Article 13 of the Central Regulation Standard Act, that wording makes a regulation effective on the third day counted from publication. Judicial Yuan Interpretation No. 161 confirms that the publication day is included.

Applying that rule gives 12 September 2026 as the date the amendment takes legal effect: 10 September is day 1, 11 September day 2, and 12 September day 3. The order provides no separate transition period. Any deadline for completing rework is set by the competent authority in the individual case.

Which imported devices qualify?

The new proviso in Article 4(2)(2) applies where:

• the device violates Article 32 or Article 33 of the Medical Devices Act; and
• a manufacturer complying with Article 22 of that Act applied the Chinese label or packaging, or attached Chinese instructions, in Taiwan.

The official amendment explanation and comparison table explain the reason: the relevant labelling violation arises from the domestic manufacturer's operation rather than being directly attributable to the original overseas manufacturer.

The Medical Devices Act supplies the conditions. Article 32 addresses Chinese labels on the smallest sales package and Chinese instructions, subject to its stated exceptions. Article 33 governs the particulars on labels, instructions or packaging, with specified exceptions and provision for electronic instructions for designated devices.

Article 22 covers the quality management system and manufacturing-permission framework. It expressly exempts designated product items from obtaining a manufacturing permit. Eligibility should therefore be described as compliance with Article 22, not as an unconditional requirement that every domestic labelling manufacturer hold a permit.

How the disposition route changes

The proviso does not authorize unilateral relabelling and resale. Article 4(1)'s stop-import, manufacture and sale-related restrictions remain unchanged. The order also does not amend the recall reporting provisions or remove the existing penalties for labelling violations. The official explanation expressly preserves penalties under Article 70; Article 70(1)(9) addresses breaches of the relevant labelling provisions.

What importers should establish

Pure Global analysis: the useful preparation is an evidence trail, not an assumed entitlement to rework. Identify who performed the domestic Chinese labelling operation, document that entity's Article 22 compliance basis, and retain the approved labelling and relevant batch records. If a recall occurs, establish whether the violation falls within Article 32 or 33 and present the facts to the competent authority before relying on the proviso.

Even when the eligibility conditions are met, the product must be suitable for rework and the authority's supervision and deadline still govern. A recall on another ground does not gain this route merely because the product also carries a label applied in Taiwan.

See Taiwan medical device registration for the wider market framework.