On June 12, 2023, Shanghai Municipal Commission of Commerce, Shanghai Medical Products Administration, Shanghai Customs District, and the Administrative Committee of Lingang New Area of China (Shanghai) Pilot Free Trade Zone jointly launched a pilot program for importing drugs and medical devices through cross-border e-commerce (CBEC).1 The pilot program will be operational until June 11, 2024.
1. Medical Products Permitted/Prohibited to be Sold via Shanghai’s CBEC Program
According to Shanghai’s CBEC pilot program, 23 categories of foreign drug and medical devices in the List of Imported Retail Goods for Cross-border E-commerce (also known as China’s CBEC positive list) are allowed to be imported to Yangshan Free Trade Zone. The specific permitted products can be found at Appendix A at the end of this article.
However, the following products are forbidden to be sold via CBEC:
Anesthetics;
Psychotropics;
Toxic drugs for medical use;
Radiopharmaceuticals;
Detoxification drugs;
Chemical precursors.
2. Requirements and Responsibilities for Companies Enrolled in Shanghai’s CBEC Pilot Program
The companies participating in Shanghai’s CBEC pilot program consist of two categories:
CBEC platform companies;
Foreign drug supply companies.
The CBEC platform companies must fulfill the conditions and obligations, including:
Company registration: registered in Yangshan Free Trade Zone.
Drug storage: having a warehouse ≧ 2,000 m2 in the zone for the storge of drugs and medical devices.
Drug traceability: establishing a traceability system for tracking the products with codes.
Sales management: reviewing the names, models, strengths, indications or application scopes, foreign marketing authorization license number, manufacturers, and contraindications; verifying the product information regularly to ensure the authenticity of the information…
Foreign drug supply companies are solely allowed to provide products to individual customers, rather than organizations, in China. As part of their participation in the program, these foreign companies are obligated to sign agreements with the CBEC platform companies. Additionally, they are required to provide Chinese translations of product information and quality control requirements to the platform companies.
3. Other CBEC Pilot Program in China
Prior to the city of Shanghai, China’s capital city Beijing and northern province of Henan had launched the first two CBEC pilot programs for the import of medical products. All three offer pathways for specific foreign medical products to enter the Chinese market. The three programs’ information as encapsulated as below:
Table 1: Cross-border E-commerce Pilot Programs in China
Beijing mode2 | Henan mode3 | Shanghai mode | |
Start | 30/12/2019 | 12/05/2021 | 12/06/2023 |
Implementation period | Not stipulated | 3 years | 1 year |
Applicable products | Medical products in the CBEC positive list (Appendix A) | 13 categories of OTC products (Appendix B) | Medical products in the CBEC positive list (Appendix A) |
Related: How to Sell OTC Drugs to China via Cross-Border E-Commerce
Appendix A: Medical products in China’s cross-border e-commerce positive list4&5
No. | Tariff code | Medical products | Notes |
1 | 30049051 | Traditional Chinese medicinal liquor (mixed or non-mixed; for preventing or treating diseases; with prescribed dose or retail packages) | Except the products that are listed in the Catalog of Wild Fauna and Flora Commodities for Import/Export and without the certificates issued by the Endangered Species Import and Export Management Office of the PRC to prove the products are not listed in the aforementioned catalog |
2 | 30049054 | Cooling Balm (Qing Liang You) (mixed or non-mixed; for preventing or treating diseases; with prescribed dose or retail packages) | / |
3 | 30051010 | Plaster bandage (having been immersed in or applied with drugs, with retail packages for medical use in surgery/ dentistry, or by veterinarian) | / |
4 | 30051090 | Other adhesive dressings, or objects with adhesive coating (having been immersed in or applied with drugs, with retail packages for medical use in surgery/dentistry, or by veterinarian) | / |
5 | 30059010 | Absorbent cotton, gauze, and bandage (having been immersed in or applied with drugs, with retail packages for medical use in surgery/dentistry, or by veterinarian) | / |
6 | 30059090 | Other soft medical filler or similar objects (having been immersed in or applied with drugs, with retail packages for medical use in surgery/dentistry, or by veterinarian) | Except the products regulated as medical devices |
7 | 30061000 | Sterile surgical catgut; sterile ecklonia kurome, sterile adhesive plaster, sterile absorbent hemostatic material, sterile anti-adhesion barrier material for surgery or dentistry use, or other similar sterile materials | Except the products regulated as medical devices |
8 | 30067000 | Gel products for human use or veterinary medicines (as an emollient between different body parts during surgery or physical examination, or as a coupling agent between body and medical device) | Except the products regulated as medical devices |
9 | 40149000 | Other sanitary and medical products made of vulcanized rubber | / |
10 | 84211990 | Other centrifuges | Except the products regulated as medical devices |
11 | 84212990 | Other machines and devices for liquid filtration and purification | Except the products regulated as medical devices |
12 | 90184990 | Other instruments and appliances for dental use | Except the products regulated as medical devices |
13 | 90189020 | Instruments and devices for measuring blood pressure | / |
14 | 90191010 | Massage equipment | / |
15 | 90191090 | Mechanical therapy equipment and psychological function testing equipment | Except the products regulated as medical devices |
16 | 90192000 | Ozone therapy devices, oxygen therapy devices, and other equipment | Except the products regulated as medical devices |
17 | 90202000 | Breathing apparatus and gas masks | / |
18 | 90211000 | Orthopedic or fracture appliances | Except the products regulated as medical devices |
19 | 90251100 | Direct-reading liquid thermometer | / |
20 | 90251990 | Other non-liquid thermometers and pyrometers | / |
21 | 90258000 | Other thermometers, hydrometers, hygrometers, and other instruments | / |
22 | 90259000 | Parts of hydrometers, thermometers, and other similar instruments | / |
23 | 96020010 | Capsules for packaging medicines | / |
Appendix B: OTC drugs permitted to be imported via Henan’s cross-border e-commerce program
No. | OTC Drug | Country/region | Manufacturer |
1 | Anti-diarrhea Pills (Kangfu Zhixie Pian) | Japan | Taiko Pharma |
2 | Lee Buan SOA Pills for Abdominal Pain (Hewei Zhengchang Wan) | Thailand | Lee Buan Soa Dispensary (Fishing Brand) |
3 | Gold Medal Medicated Oil (Jinpai Fengyoujing) | Singapore | Leung Kai Fook |
4 | Tiger Balm (Zhangbo Yuxiang Ruangao) | Singapore | Haw Par Corporation Limited. |
5 | Wood Lock Medicated Balm (Huoluo You) | Hong Kong, China | Ying Kut Lee Medicine Factory Ltd. |
6 | Po Chai Pills (Puji Wan) | Hong Kong, China | Li Chung Shing Tong |
7 | Female Health Capsules (Jianfu Jiaonang) | Hong Kong, China | Grand Pharmaceutical Group Limited |
8 | Mint Huoluo Paste (Bohe Huoluo Gao) | Hong Kong, China | Ling Nam Medicine Factory (H.K.) Co., Ltd. |
9 | Mint Hubiao Oil (Bohe Hubiao You) | Hong Kong, China | PO SUM ON Medicine Factory Limited. |
10 | Lingnan Zhenghonghua Oil (Lingnan Zhenghonghua You) | Hong Kong, China | Ling Nam Medicine Factory (H.K.) Co., Ltd. |
11 | Lingnan Heigui Oil (Lingnan Heigei You) | Hong Kong, China | Ling Nam Medicine Factory (H.K.) Co., Ltd. |
12 | Pills for Abdominal Pain and Stomach Health (Dutong Jianwei Zhengchang Wan) | Hong Kong, China | HK Lee Man Shan Medicine Manufacturing Ltd. |
13 | Four Season Ping’an Oil (Siji Ping’an You) | Hong Kong, China | Luen Wan (H.K.) Medicine Ltd. |
