Pudong New Area in Shanghai has significantly improved the efficiency of adding Chinese labels to imported medical devices, with 40 enterprises taking advantage within six months of the implementation of the new regulations.

Following the State Council's 2023 directive to align the China (Shanghai) Pilot Free Trade Zone with international trade standards, the Pudong market supervision administration introduced trial regulations on Jan 1, 2025. These expanded the scope of labeling eligibility beyond three initial bonded zones to include all Shanghai FTZ-based agents of overseas medical device registrants.

The reform integrates international trade rules with domestic medical device regulations, enabling faster market entry while maintaining safety standards. Monthly labeling volume now exceeds 600,000 units in the Waigaoqiao Free Trade Zone alone.

Domestic agents handle labeling, reducing errors caused by overseas operators' limited Chinese proficiency and cutting compliance costs compared to international procedures.

Bard Healthcare Science (Shanghai) Co Ltd, a subsidiary of global medical technology leader BD, reports enhanced supply chain agility through localized labeling, enabling quicker response to regulatory changes and market demands.

Pudong authorities have launched an electronic reporting system to monitor compliance, conducting remote and on-site inspections of labeling quality and regulatory adherence.

The streamlined process facilitates the entry of medical devices into the Chinese market, accelerates customs clearance, and ensures product safety for Chinese consumers, creating a win-win situation for international medical device companies and domestic healthcare systems.