On 18Mar2021, from NMPA published the final version of “Regulations on the Supervision and Administration of Medical Devices” (i.e., State Council Order #739) and will come into force on June 1, 2021.
The results of the reform of “decentralization, regulation and service” encourage the innovation and development of the industry and release the innovative vitality of the market. The “Regulations” clearly set up a number of important systems for medical device registrants, such as the filing person, clinical evaluation, conditional approval, emergency use, unique identification traceability, professional and professional inspectors, responsibility interviews, and punishment to people, etc., focusing on encouraging innovation Development, full life cycle quality supervision requirements, comprehensive regulations on medical device registration and filing, production, operation and use, handling and recall of adverse events, supervision and inspection, and legal responsibilities.
When the draft version of this regulatory update was published in June 2018 from the existing existing Order No. 650.that the changes were intended to streamline Chinese market access for foreign manufacturers, crack down on non-compliance, and establish a unique device identification (UDI) system for medical devices. Since that time, new UDI requirements have been separately announced by the NMPA; their rollout was subsequently postponed until the beginning of this year in response to the COVID-19 pandemic.
The Chinese government main objective reflected in issued draft changes to the country’s medical device regulatory framework that would allow easier market access for foreign manufacturers.
Drafted version was how different from Order No.650:
- China Food and Drug Administration (CFDA) registrants may submit either self-test reports or test reports obtained from qualified organizations..
- Class II medical devices would not be required in principle to provide CERs in their CFDA premarket applications.
- The official definition of medical device legal manufacturer would be changed to that of marketing authorization holder.
- Innovative medical devices imported into China would not require home-country approval certificates.
- CFDA plans to roll out a UDI system for the Chinese medical device market in the near future.
- Importing or distributing used medical devices in China would be forbidden.
- Proposed changes would affect product test reports, clinical evaluation report (CER) requirements, importing of innovative devices, and more.
- The Marketing Authorization Holder (MAH) system will be rolled out nationwide. Except for certain high-risk medical devices, contract manufacturing of medical devices will be permitted.
- Opens to self-testing reports: the new Regulations allow self-test reports as well as test reports issued by an in-country qualified testing lab.
- Conditional approvals will be made available for devices treating rare diseases, critical diseases that do not have an effective treatment method or responding to abrupt public health incidents. Re-positioning local legal agents: Foreign device MAHs will still need to appoint a Chinese legal entity to submit regulatory applications and correspond with regulatory authorities. Nevertheless, these local appointees will only play a secondary role to assist the foreign device MAHs in the performance of compliance obligations.
On 18Mar2021, the final document of this regulatory update differs in some logical ways from the draft version published in 2018. The major alterations which are worthy to be noted are as follows:
- For all Class II and III device registrations,In-country testing may no longer be strictly required (Article 14).
- For Innovative Device applications the requirement for home-country approval has been eliminated (Article 15).
- Clinical evaluation exemption criteria may be expanded (i.e., not necessarily limited to the Exemption Catalogue) (Article 24).
- In the case of online sales, new requirements have been introduced (Article 46).
Penalties directed at companies in violation of the Regulations have been strengthened (Chapter 7).The NMPA is expected to release guidance documents and further sub-regulations to support this round of regulatory changes.