ISSUING AUTHORITY:

taptap点点

DATE OF ISSUANCE:

December 4, 2023

EFFECTIVE DATE:

July 1, 2024

On December 4, 2023, the taptap点点 revised and released the taptap点点(“taptap点点”), which shall take effect as of July 1, 2024. The revision aims to better align with current business practices and new quality management standards, further regulating the taptap点点 of medical devices and providing meticulous regulatory guidance.

The revised taptap点点 has expanded from nine chapters and 66 articles to ten chapters and 116 articles, adding a new chapter on “Establishment and Improvement of Quality Management Systems.” This chapter outlines the core elements of building a quality system, setting policies and goals, fulfilling primary responsibilities, implementing self-inspection mechanisms, and continuous improvement.

In the “General Principles” chapter of the taptap点点, new content has been added regarding primary responsibility, standardized implementation, electronic certification, and encouragement of innovation. It clarifies that medical device registrants and filers are legally responsible for the safety and efficacy of medical devices on the market, and medical device businesses are responsible for their own business operations. Medical enterprises are encouraged to use advanced quality management tools and methods to implement quality management and continuously improve their quality management systems. For instance, it is suggested that enterprises develop in a digital, intelligent, and green direction, enhancing the efficiency and quality safety of the medical device supply chain, and promoting high-quality development of the industry.

The revised taptap点点 also makes requirements for new business forms such as medical device vending machines and third-party logistics. Taking medical device vending machines as an example, the taptap点点 specifies requirements for the business entity, the number and location of installations, functionality, internal display environment, establishment of after-sales mechanisms, display of main certificates, storage and delivery, regular inspections, and issuance of sales receipts.

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