On April 22, 2025, with the joint approval of the Ministry of Ecology and Environment, the Ministry of Agriculture and Rural Affairs, and the National Medical Products Administration, GACC issued the "Announcement on Clarification on Certain Goods and Articles No Longer Subject to Supervision as Entry-Exit Special Articles"(Announcement [2025] No. 65, hereinafter referred to as the "Announcement"), which specifies that the Customs will no longer supervise goods and articles managed under regulations for pharmaceuticals, veterinary drugs and medical devices, as well as imported and exported environmentally-purposed microbial agents as entry-exit special articles.
I. Adjusting the supervision scope for entry-exit special articles represents a concrete step in implementing the newly revised "Frontier Health and Quarantine Law of the People's Republic of China"
The newly revised "Frontier Health and Quarantine Law of the People's Republic of China" adheres to the principles of risk management, evidence-based policy implementation, and efficient response. It effectively integrates epidemic prevention and control with economic and social development while thoroughly addressing the objectives of safeguarding public health, ensuring the well-being of the people, and promoting seamless international communication and trade exchanges. Article 22 of the Law introduces new stipulations regarding the health quarantine of entry-exit special articles. Staying true to the legislative purpose of frontier health quarantine, it redefines the supervision scope to include "blood and other human tissues, pathogenic microorganisms, biological products, and other items posing risks to public health safety" while explicitly excluding "items managed under regulations for pharmaceuticals, veterinary drugs, and medical devices" from this scope.
II. Detailed changes in customs health quarantine supervision requirements following the adjustment of the supervision scope for entry-exit special articles
Following this adjustment, goods and articles managed under regulations for pharmaceuticals, veterinary drugs, and medical devices, will no longer require customs health quarantine approval for entry-exit special articles. Customs will also cease conducting health quarantine inspections based on the identification of these as entry-exit special articles. If an enterprise has obtained certification documents approved by the competent authorities for pharmaceuticals, veterinary drugs, and medical devices in China, the goods submitted to customs for import can be deemed as falling under the management of pharmaceuticals, veterinary drugs, and medical devices. If an enterprise has obtained certification documents approved by the competent authorities for pharmaceuticals, veterinary drugs, and medical devices in China or internationally, the goods submitted to customs for export can be deemed as falling under the management of pharmaceuticals, veterinary drugs, and medical devices.
Following this adjustment, the import and export of environmentally-purposed microbial agents will no longer require health quarantine approval as entry-exit special articles. Customs will also discontinue health quarantine sampling and testing for such environmentally-purposed microbial agents.
III. Goods and articles that are no longer subject to health quarantine supervision as special items must still comply with other customs regulatory requirements
Following this adjustment, goods and articles regulated as pharmaceuticals, veterinary drugs,and medical devices, as well as imported or exported environmentally-purposed microbial agents, will be subject to health and quarantine inspection by Customs in accordance with the procedures for general entry-exit goods and articles. Requirements for other customs supervision remain unchanged.
(Contributed by: Department of Health Quarantine, Research Center of GACC for International Inspection and Quarantine Standards and Technical Regulations, Shenzhen Customs, Beijing Customs, Kunming Customs)
Disclaimer：The above content is translated from Chinese version of GACC. The GACC version shall prevail.