CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
ing the change application. In addition, a whole- sale drug distributor must have a self-operated warehouse that is appropriate for its range of products and scale of operations. If a wholesale drug distributor (including a MAH) is an online seller, it will report to the provincial 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 distributor should maintain a distribu- tion 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 applica- tion, 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, sub- ject to an application for renewal within 30 to 90 working days before expiry. Any violations of the Quality Management Stand- ards for the Operation of Medical Devices may lead to the revocation of the wholesale medical devices distribution licence due to the impact on product safety and effectiveness. A whole- sale medical device distributor is therefore also required to comply with the revised Quality Man- agement Standards for the Operation of Medi- cal Devices, which officially came into effect on 1 July 2024. This includes new requirements related to the establishment and improvement of the distribution quality management system.
If a medical device distributor (including a MAH) is an online seller, it will complete the medical device online sales information form. This form requires pre-filing with the relevant provincial MPA, providing information such as the medi- cal device manufacturing licence, the medical device distribution licence or medical device fil- ing certificate number, etc. Any changes to the filed information should be promptly notified. 6.2 Different Classifications Applicable to Pharmaceuticals For the different classifications that apply to pharmaceuticals (such as “available only on prescription” ), see 1.3 Different Categories of Pharmaceuticals and Medical Devices . Addi- tionally, a drug retailer will not offer free prescrip- tion drugs or Class A OTC drugs for purchase or commodity. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The import and export of pharmaceuticals and medical devices are subject to the Customs Law of the PRC, the DAL and various relevant regula- tions. The SAMR, the NMPA, the NMPA’s designated drug test institutions, the Ministry of Commerce of the PRC (the “MOFCOM” ) and China Cus- toms all have the power to enforce relevant laws and regulations. The NMPA and its local coun- terparts govern the administration of the use of imported pharmaceuticals and medical devices.
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