NMPA Facilitates The Usage Of Medical Device Master Files
The NMPA issued a notice on further clarifying matters related to the registration and use of the master files of medical devices on January 18, 2023.
Combined with the registration and use of medical device master files, the following matters are clarified:
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Medical device master file is a form of technical data, such data is submitted directly by its owner to the medical device regulator, used to authorize the applicant for registration of medical device products in the declaration of medical device registration and other matters. The registration of medical device master file is a voluntary act.
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Medical device master file registration is mainly related to medical device raw materials. Medical device master file system applies to the medical device registration applicant in China’s imports of Class II, Class III and domestic Class III medical devices (including in vitro diagnostic reagents) registration, changes, clinical trial approval and other applications referenced in the registration of the master file. According to the actual situation, local NMPA can carry out the main file registration items of domestic Class II medical devices by referring to this announcement.
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The medical device master file system focuses on the goal of scientific supervision, solves the bottleneck problem of registration and application, improves the efficiency of review and approval, provides a positive solution to the current problems faced by the medical device industry and is in line with international standards, facilitates the selection of raw materials and key components for medical device manufacturers, and simplifies registration and application. At the same time, the principle of voluntary and confidential registration of the master file has the characteristics of being suitable for China’s national conditions and strong operability, and can well protect the intellectual property rights of the master file owner. The master file registration system also serves the major strategic needs of the country, helps solve the “bottleneck” problem, stimulates the innovation vitality of medical devices and related fields, and enables the innovation results to benefit the people.
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The medical device registration applicant shall guide and assist the master file owner to establish the master file in accordance with the relevant requirements of the medical device registration application data, and take full responsibility for the medical device declared. The owner of the master file can submit the master file registration information through the registration platform according to the requirements of this announcement, and obtain the master file registration number after registration. NMPA CMDE will review the master file information after the registration submission of related medical device. Therefore, the public announcement of the relevant master file registration information only means that the content of the relevant medical device master file has been registered, and does not mean that the relevant content of the medical device master file, including the name of the master file, has undergone technical review or the relevant raw materials have been applied in the listed medical devices.
