2023.01.30 ZHOU, Feng (Frank)、Beth Sun
Medical software is commonly used in the life sciences and healthcare industry. This article answers the most frequently asked questions regarding the way China regulates medical software.
1: Is medical software regulated as a medical device in China?
If the software is standalone software used to achieve a medical purpose, it will fall under the definition of a medical device under PRC law and will need to be registered as a medical device with the National Medical Products Administration (“NMPA”, which is China’s equivalent of the FDA). If it is not standalone software but is dependent on hardware to achieve its purpose, the software will be deemed as an integral part of the hardware, and the hardware may need to be registered as a medical device.
If the medical software does not serve a medical purpose, it will not be treated as a medical device. A “medical purpose” under PRC law includes the following: (1) the diagnosis, prevention, monitoring, and treatment or relief of diseases; (2) the diagnosis, monitoring, treatment, relief or functional compensation of injuries; (3) the inspection, substitution, adjustment or support of physiological structures or physiological processes; (4) the support or maintenance of life; (5) the control of pregnancy; and (6) the provision of information for the purpose of medical treatment or diagnosis through the examination of a sample from a human body 1.
Sometimes it will not be clear whether the software serves a “medical purpose”. For example, wearable devices such as Apple Watches and Xiaomi Watches are able to collect the daily heath data of a user, such as the user’s body temperature, heart rate and blood oxygen levels. If an app installed on a wearable device uses the data to monitor and inform the user’s general health conditions, it does not usually need to be registered as a medical device in China, although we advise to add proper disclaimers in the product manual that the data and/or application shall not serve any medical purpose. If the application does serve a medical purpose, registration will be required. According to public information, the ECG applications of various brands have been registered as Class II medical devices in China. It is advisable to consult with legal advisors and the NMPA to determine if particular software should be regarded as serving a “medical purpose”.
2: If medical software needs to be registered as a medical device in China, which class will it fall under?
China classifies medical devices as Class I, Class II and Class III according to the risk level of the device and Class III devices are subject to the most stringent regulation. Medical software is usually registered as a Class II or Class III device. When assessing the risk level of medical software, the NMPA will assess not only the purpose of the medical software, but also the maturity and robustness of the underlying algorithms and data. If the medical software generates diagnostic recommendations and conclusions rather than reference data for healthcare professionals, it will be deemed to have a higher risk level.
3：What is the process and timeline for medical device registration with the NMPA? Is there an expedited process?
If medical software falls under the classification of a medical device under PRC law, it must obtain registration from the NMPA before it can be imported and sold in China. This process typically takes at least six months. Except for statutory exemptions, medical software must first pass clinical evaluation. The applicant shall then submit the requisite application documents together with the clinical evaluation materials to a competent NMPA authority. Lastly, the NMPA will conduct a technical review and where needed, inspect the applicant’s quality management systems for R&D and production, and grant registration if the application documents are satisfactory.
In statutory circumstances, the registration process for medical software may be expedited or prioritized:
(1)Special Registration Process for Innovative Products: If the technical features of the medical software are of a pioneering nature in China and demonstrates fundamental improvements against existing products in terms of safety and effectiveness, and the development and patent status of the medical software meets NMPA requirements, the product will enjoy special treatment by the NMPA, such as early consultation and special support from a dedicated team.
(2)Priority Registration Process: If the medical software satisfies one of the following conditions, it will enjoy priority registration: (i) it is used for the diagnosis or treatment of rare diseases, oncology, geriatric or pediatric diseases, with obvious clinical advantages, or (ii) it is a pioneering product with pressing clinical need, or (iii) it is enlisted as one of the key research programs of the state.
(3)Emergency Registration Process: Medical software needed during public health emergencies can enjoy emergency registration with the NMPA.
(4)Combined Registration Procedures: If the medical software cannot work independently without other software, it may be incorporated into the modules of other medical software for combined registration.
4: Is a clinical trial mandatory for the registration of medical software as a medical device?
Under PRC law, clinical evaluation is required for the registration of medical devices unless otherwise exempted. The NMPA has published a catalogue of medical software which is exempt from clinical evaluation. This software includes trace analysis software, clinical management software, radiotherapy recordings and verification system software, radiotherapy contouring software, medical image storage and transmission system software, medical image processing software, and data processing software.
Even if the software is not exempt from clinical evaluation, clinical trials are not the only route for clinical evaluation. Under PRC law, to prove the safety and effectiveness of a medical device, the applicant may conduct clinical evaluation through either clinical trials, or the analysis and evaluation of the clinical literature and data of comparable devices. The NMPA has published guidelines on which route should be used during the registration.
5: In contrast to hardware devices, are there any special regulatory requirements for medical software?
Yes. Due to its digital nature, medical software is subject to various special regulatory requirements during its registration, manufacturing, and commercialization, to list a few:
(1)Registration. During the registration process, medical software will be subject to special requirements on cybersecurity. The NMPA has also clarified the regulatory requirements for software upgrades after the registration of the medical software. According to the applicable guidelines, software upgrades are divided into “major” and “minor” upgrades. Major upgrades refer to those that affect the safety and effectiveness of a medical device, while others are regarded as minor upgrades. A major upgrade is subject to change registration with the NMPA, which requires more data and is more time-consuming. Minor upgrades are not subject to change registration, and the applicant can file all minor upgrades in the next change registration.
(2)Manufacturing. In 2019, the NMPA promulgated the manufacturing practice for standalone medical software, which lays out the special requirements on the manufacturing of medical software. To list a few:
Personnel: for black-box testing, it is a requirement that the personnel for software development shall not concurrently serve as the personnel for software testing; and
Documentation: the protocol for the maintenance, verification, and upgrade of software development and the testing environment and the release of the product shall be documented; and records should be kept.
(3)Commercialization. In addition to general compliance requirements during commercialization (such as permit requirements, promotion compliance, anti-corruption and competition law compliance), medical software is subject to higher compliance requirements regarding the use and transfer of data, personal information and privacy.
Conclusion:
Medical software backed by digital and AI technologies is re-shaping the landscape of the life sciences and healthcare industry. Investors, industrial players and regulatory authorities are all closely monitoring its development, albeit from different perspectives. Like the rest of the world, China is interested in the best practice to explore the full potential of medical software, while preserving public interests and health. The laws and practice around medical software is continuously evolving, and we will monitor and report all the latest developments.
1.See Article 103 of the Medical Devices Supervision and Administrative Regulations.
