CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
An application for imported medical devices is required to be submitted to the NMPA for the filing (Class I) or application for review (Class II and Class III). Sup- porting documents are also important when submit- ting the application to prove that competent authori- ties permit the marketing of these medical devices. In terms of the timeframe for acceptance, technical review, verification and approval of registration, there is no specific process for accelerated approval for the filing/registration of imported medical devices. Overseas research information and clinical trial data could be used to support the marketing authorisa- tion applications for drugs and medical devices in the PRC if the sources, research institutions or laboratory conditions, quality system requirements, and other management conditions relating to such information and data are in line with the regulatory requirements in the PRC. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Pharmaceuticals Pharmaceutical manufacturing enterprises are required to obtain drug manufacturing licences, even for MAHs that lack manufacturing capacity and out- source manufacturing work to other manufacturers (CMO). In the event of CMO and/or sub-packaging, the manufacturing enterprise that carries out the manufacture and/or sub-packaging also has to obtain the corresponding manufacturing licence. The manu- facturing enterprise must submit an application and relevant materials to the provincial MPA where it is located. The authority will organise technical review and evaluation of the application materials and on- site inspection, and will then decide whether to grant approval for the licence or not. The manufacturing licence is valid for five years. The licence holder may apply for renewal six months prior to the expiry date, and the renewed licence shall remain valid for another five years. In recent years, the NMPA has imposed more strin- gent and detailed requirements on CMO, including
strengthening the responsibility of MAHs, standard- ising the process of CMO, and formulating on-site inspection guidelines. Medical Devices In line with the Measures for the Supervision and Administration of Medical Device Production (2022 revision), the types of authorisation for medical device manufacturers differ depending on the classification of devices: • Class I devices – the manufacturer will conduct a filing with the municipal MPA for the manufacturing of Class I devices; and • Class II and III devices – a manufacturing licence will be granted by the provincial MPA following the result of the review and on-site examination. The authority will conduct a review of the application materials and an on-site inspection. A filing for Class I devices does not specify the duration of authorisa- tion, while a manufacturing licence for Class II and III devices is valid for five years and can be renewed for another five years within 30 to 90 working days prior to expiry. In recent years, the NMPA has revised the medical device GMP to enhance risk management, quality assurance systems and supervision of contract manu- facturing, and to promote digital-intelligent transfor- mation in manufacturing. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and In support of the revised DAL (2019), the SAMR offi- cially implemented the Measures for the Supervision and Administration of Drug Quality in Operation and Usage in January 2024, and the NMPA issued the Announcement on Further Improving the Supervision and Administration of Pharmaceutical Distribution in April 2024. These measures further clarify the condi- tions, procedures and quality management require- ments for obtaining a drug distribution licence. Medical Devices Pharmaceuticals
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