CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
Generally, a wholesale drug distributor must maintain a drug distribution licence, with an exception for drug MAHs that sell their drugs as a wholesaler without obtaining a drug distribution licence. The licence is valid for five years and can be renewed two to six months before expiry. The relevant provincial MPA will review the application, conduct on-site examinations and decide whether to approve it. An application for changes to licensed matters of a drug distribution licence must be submitted to the issuing authority, which will make its decision within 15 working days from the date of receiving the change application. Violations of the GSP requirement for drugs may lead to the revocation of the drug distribution licence. If a wholesale drug distributor (including a MAH) is an online seller, it must report to the competent MPA by filing an information report form. Medical Devices The wholesale distribution of Class I devices does not require authorisation. For Class II devices, a distribu- tor should maintain a distribution filing receipt from the provincial MPA, which will grant receipt if all the required documents are submitted. The wholesale distribution of Class III devices requires a distribution licence from the provincial MPA, which will review the application, conduct examinations when necessary and decide whether to approve the application. A filing receipt for Class II devices does not specify a validity period, while a distribution licence for Class III devices is valid for five years and can be renewed for another five years, subject to an application for renewal within 30 to 90 working days before expiry. Violations of the GSP requirements for medical devic- es may lead to the revocation of the wholesale medi- cal devices distribution licence. If a medical device distributor (including a MAH) is an online seller, it must report to the competent MPA by filing an information report form.
In recent years, the NMPA has issued detailed require- ments for online sales of medical devices, aiming to strengthen on-site inspection and standardise rele- vant quality management. 6.2 Different Classifications Applicable to Pharmaceuticals For the different classifications that apply to pharma- ceuticals (such as “available only on prescription”), see 1.3 Categories of Pharmaceuticals and Medical Devices . Additionally, a drug retailer will not offer free prescription drugs or Class A OTC drugs for purchase or commodity. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The importation and exportation of pharmaceuticals and medical devices are subject to the Customs Law of the PRC, the Foreign Trade Law of the PRC, the DAL and various relevant regulations. In 2025, China con- sistently implemented policies to support enterprises in expanding overseas and to promote international co-operation by fostering a dual circulation dynam- ic, namely to drive growth through robust domestic demand while maintaining international openness, offering Chinese firms a more resilient home market and foreign companies greater access to China’s vast consumer base and collaborative opportunities. For instance, in 2025, the NHSA established the China- Association of Southeast Asian Nations (ASEAN) medical procurement platform to promote transna- tional communication and regulatory alignment and to ease access into the ASEAN market. At the point of entry of pharmaceuticals and medi- cal devices, the NMPA and its designated drug test institutions, the Ministry of Commerce of the PRC (MOFCOM) and China Customs all have the power to enforce relevant laws and regulations as well as to conduct continued supervision in subsequent stages. After pharmaceuticals and medical devices enter the domestic market for circulation and clinical use, the NHC, the NMPA and other departments under the
70 CHAMBERS.COM
Powered by FlippingBook