China continuously promotes new policies to facilitate customs clearance of imported medical devices

With the recent Global Conference on Health Industry Cooperation and the China-CEEC Summit on Innovation and Development in Medicine and Health, cooperation between China and CEECs in the fields of bio-pharmaceuticals, medical devices, vaccine research and development, and health services has been further strengthened.

In order to promote trade and investment liberalization and facilitation, the Ministry of Commerce supports Ningbo, Zhejiang Province and other places in the construction of demonstration zones and industrial cooperation parks with high standards for economic and trade cooperation between China and CEEC countries, so as to further promote customs clearance and  attract more CEEC enterprises to invest in China.In the field of medical devices, what favorable measures are there to promote the import of medical devices and bring convenience to the customs clearance of foreign trade?

Ⅰ.Tax reduction reform to reduce the customs clearance burden on enterprises

i.Lowering tax rates on some medical devices

According to the Import and Export tariff of the people’s Republic of China, China dynamically adjusts the tax rates of imported commodities every year.On January 1, 2021, the tariff Adjustment Plan for 2021 issued by the tariff Commission of the State Council has been formally implemented, which proposes to impose provisional import tariff rates lower than the most-favoured-nation rate on 883 commodities, including reducing import tariffs on medical devices such as artificial heart valves and hearing aids.

The Boao Lecheng International Medical Tourism pilot Zone in Hainan, preferential policies have also been formulated to enjoy medical technology access for clinical application and research, examination and approval of large-scale medical equipment, allowing overseas capital to set up medical institutions, and reducing import tariffs on medical devices and drugs.

ii.Optimization of import customs clearance mode

In July last year, the General Office of the State Council has issued the implementation opinions on further optimizing the business environment and better serving the main body of the market, which called for further improving the efficiency of import and export customs clearance and promoting the “advance declaration” of import and export goods, that is, enterprises go through the declaration formalities in advance, and the customs go through the formalities of inspection and release of the goods immediately after the goods arrive at the customs supervision workplace.After the enterprise makes a “summary declaration” and the customs completes the risk investigation and disposal, the enterprise is allowed to lift the goods away immediately.Pilot projects of “direct lifting of imported goods by ship” and “direct loading of export goods  upon arrival at ports” can be carried out in regulatory workplaces that meet the requirements.

 iii.The simplification of customs clearance process and “single window” transaction are in the promotion

In April 2021, the General Office of the State Council has clearly requested that the “single window” of international trade be connected with information platforms such as ports, railways, and civil aviation, as well as banks, insurance and other institutions, so as to improve the level of cross-border facilitation.

In addition, according to the work deployment of the General Administration of Customs, in 2021, the General Administration of Customs will further sort out the current supervision documents for import and export links, and continue to streamline it in conjunction with relevant state departments. Up to now, the number has been streamlined by more than half.

Ⅱ.The increase in convenience to improve quality and efficiency for import customs clearance

i.Approval for the import of special clinically needed and special medical devices has been accelerated

In early 2020, China issued a notice on “Ten measures to Deal with the Impact of the Epidemic and Promote the Steady Growth of Foreign Trade”, which proposed to simplify the quarantine examination and approval of imported special medical items.For vaccines, blood products, reagents and other special medical articles imported for the purpose of epidemic prevention and control for the treatment, prevention and diagnosis of COVID-19, under the premise that the risk can be controlled, the port customs shall directly check and release on the strength of the certificate of the competent department.

In fact, as early as December 2019, the State Drug Administration has issued“ The Guidelines for Conditional Listed Approval of Medical Devices, which clearly points out that in order to address the clinical quality requirements of seriously life-threatening diseases, the review and approval of related medical devices should be accelerated.

In March 2021, the State Drug Administration has announced“ The Emergency Examination and Approval Procedure for Medical Devices (Revised draft for comment).” Based on the experience summarized by COVID-19, the version issued by the State Drug Administration in 2009 has been revised in order to effectively prevent, control and eliminate the harm of public health emergencies.

 ii.The improvement of the level of informationization and intelligence in customs clearance

At the China-CEEC Summit held in February 2021, national leaders put forward the major initiative of deepening cooperation on customs trade security and customs clearance facilitation, and launching pilot cooperation on smart customs, smart borders and connectivity for all.

In recent years, local customs have achieved certain results in intelligent supervision. Starting from 2020, under the mobile remote supervision of Guangzhou Customs, enterprises do not need to wait for customs personnel to come to the door, and on the premise of meeting the requirements of customs supervision, they make an “online reservation” in advance and cooperate with the customs to complete the remote supervision work online.Guangzhou Customs actively docks with medical institutions and carries out remote operations to supervise the operation process and check the key links, so as to achieve “non-contact” rapid customs clearance and service to ensure the stability of the supply chain.

 iii.Hierarchical management on imported medical devices

On March 17, 2020, the Suzhou Free Trade Zone “Measures for the Classification Management of Imported R&D (Testing) Unregistered Medical Devices” has been formally implemented.

The so-called hierarchical management, that is, the entry enterprise shall carry out the import reporting procedures and formulate independent management plans, and the functional departments shall strengthen supervision during and after the event. The customs department shall carry out customs clearance procedures in accordance with the relevant provisions according to the explanatory letters issued by the Economic Development Committee of Suzhou Industrial Park, the Bureau of Science and Technology Informatization, and the Market Regulatory Administration, so as to improve the efficiency of import customs clearance and the degree of facilitation.

According to the new management measures, scientific research institutions, R & D or production enterprises in Suzhou Free Trade Zone can apply for the import of testing unregistered medical devices or spare parts (non-diagnostic reagents) for R & D (testing) by general trade.The management department carry out hierarchical  management of the imported key points and general medical devices or parts according to the relevant catalogues, so as to facilitate product  customs clearance and speed up the development and listing of medical device .

For more information about China’s medical device registration，contact info@inspirativemed.com