香港醫療儀器額外標籤要求：理解 TR-005

Under the current MDACS framework, you have flexibility. Option II allows the "Special Listing Information" (HKMD No. and LRP info) to be provided on a separate document (like a delivery note or a 'Dear Customer' letter) provided with the shipment. However, for HA tenders in 2026, the HA often demands that the listing info be physically present on the outer sales unit. You can apply these stickers locally at a 3PL in Hong Kong, provided your Local Responsible Person (LRP) has a documented QMS procedure for over-labelling and assumes responsibility for the label's integrity.

This is a critical distinction. While the MDACS (Technical Reference) allows a 6-month grace period for label updates, the Hospital Authority (HA) and Department of Health (DH) procurement rules for 2026 are separate. To win a tender under Stage C3, you must show that your device is listed. Most HA contracts now include a "Special Condition" that requires the HKMD number to be visible on the packaging at the time of delivery, effectively nullifying the 6-month grace period for public sector sales.

The 2mm rule is strictly enforced for the Special Listing Information. For very small devices where physical space makes a 2mm font impossible on the primary label, the MDD allows the information to appear on the secondary packaging (outer box) or a package insert. Using a QR code to link to an e-IFU is encouraged in 2026, but it cannot replace the physical presence of the LRP’s name and local telephone number on the sales unit or the accompanying delivery document.

Yes, the requirement holds. Even for professional-use SaMD, the Medical Device Division (MDD) requires that the fact that an English-only IFU is used must be clearly communicated. For software, this is handled via Digital Labelling. You must display the Listing Number and a warning statement (e.g., "沒有中文版使用說明" - No Chinese version of IFU) should be shown on the landing page or the digital "Help" menu. In 2026, with the establishment of the CMPR, there is an increased push for at least a Chinese-language "Quick Start Guide" to be available for all devices.