China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on June 1, 2021. While the 2021 RSAMD largely follows the structure of the 2014 version, it does introduce a few important changes of which medtech companies interested in marketing in China should be aware.
NATIONWIDE ROLLOUT OF MARKETING AUTHORIZATION HOLDER (MAH) SYSTEM
Device companies focused on research and development will now be able to more easily contract the manufacturing of the devices out to third-party contract manufacturers.
An MAH located overseas (including those in Hong Kong, Macau, and Taiwan) is required to appoint a local entity incorporated in mainland China to act as its regulatory agent, which shall be responsible for submitting applications for clinical trials and/or marketing authorizations with the National Medical Products Administration (NMPA), and shall assume joint and several liability with the overseas MAH in terms of product quality and after-sales services.
Some medical devices (such as invasive medical devices with high risk, the catalogue of which is issued by the NMPA and subject to the NMPA’s adjustment from time to time) are still not permitted to be produced by contract manufacturers.
It is unclear yet whether foreign MAHs will be allowed to contract the manufacturing to Chinese local contract manufacturers while they intend to register the products as imported medical devices.
INCREASED LEGAL LIABILITY FOR MAHS
MAHs must establish and implement an effective quality management system, a post-approval study and risk control plan, and a product tracing and recall system, and conduct adverse event monitoring and reevaluation.
MAHs will be subject to a fine of 15–30 times the sales revenue for manufacturing and distribution of unapproved Class II and Class III medical devices, and a fine of 5–20 times the sales revenue for manufacturing and distribution of medical devices that do not conform to mandatory standards or technical requirements.
The 2021 RSAMD also introduces personal liability on the legal representatives, main responsible persons, and directly responsible supervisors or other personnel of MAHs. The income of these individuals during any period of noncompliance can be confiscated. They will also receive an administrative fine up to three times their income and a permanent debarment from engaging in the manufacturing or distribution of medical devices under serious circumstances.
NEW PATHWAYS AND EXEMPTIONS
- Exemption from clinical evaluation: Mature products of which safety and effectiveness can be proven by nonclinical evaluation are now exempt from clinical evaluation.
- Exemption from submitting COO approval: Foreign manufacturers seeking approval for innovative imported medical devices that will be launched first in China will be exempt from the country of origin (COO) approval at the time of marketing authorization application, while the same COO approval will still be required for noninnovative devices.
- Conditional approval of marketing authorization: Medical devices urgently needed for the treatment of rare diseases and critical life-threatening diseases without existing effective treatment measures, as well as in response to public health emergencies, etc., shall be subject to condition approval of marketing authorization, and conditions to such approval shall be indicated in the registration certificate thereof.
- Emergency use authorization: Devices to be used within a designated scope for a limited period of time treating rare diseases or critical diseases that do not have an effective treatment method or responding to significant abrupt public health incidents or other emergencies that may impose a severe threat to public health shall be eligible for emergency use authorization.
- Unauthorized in vitro diagnostics (IVDs) used in laboratory-developed testing (LDT): Qualified medical institutions are allowed to develop IVDs by themselves and to use such self-developed unauthorized IVDs within their own premises under the guidance of licensed physicians, if there is no same type of such self-developed IVDs available in China. However, detailed rules in relation to this regulation (e.g., the standards for “qualified medical institutions,” the scope of “own premises,” and the extent of permitted use) are unclear yet, as they await the authorities’ further clarification.
- Use of investigational devices in clinical trial sites: Investigational medical devices undergoing clinical trials and used for critical, life-threatening diseases without an effective treatment method can be made available for patients with the same condition (other than the trial subjects) in the clinical trial sites, provided that the devices can confer clinical benefits on patients based on medical judgment. The usage must obtain ethics committee approval and the patients’ informed consent. Safety-related data collected from aforesaid extended clinical trials can be used for further application of marketing authorization for that medical device.