On July 22, 2021, the China State Administration for Market Regulation has released a new version of the "Administrative Measures for the Registration and Filing of Medical Devices", which will be executed and come into effect on October 1, 2021. In addition, the “New Regulation for Supervision and Administration of Medical Devices” (RSAMD) via decree No.739 had recently become effective on June 1st, 2021.
Given the significant changes and major impacts to the registration processes in China by these two new implementations, the Qualtech team would like to update our clients thoroughly on this important matter. The regulatory amendments are thereby not only interesting for those who are already operating in China, but also those, who are planning to tap into the Chinese Medical Device Market in the future:
1. Decree No. 739 - China’s New Regulation for Supervision and Administration of Medical Devices (RSAMD):
The new RSAMD had been issued by China’s PRC State Council as State Council Order Number 739 on February 9, 2021. The order subsequently has taken effect 4 months later, on June 1st, 2021. Bringing along several important updates, which include, China NMPA’s newly implemented measures to specifically encourage innovative medical devices. That is, by allowing for simplified and priority review pathways and approval procedures. Besides the former, NMPA further added conditional approval pathways as well as emergency use regulations for selected urgently needed medical devices.
Another novelty stemming from the new RSAMD is that NMPA will also start to accept self-testing reports for products other than Class I Medical Devices under certain conditions. Thus, extending the limitation previously set by the old RSAMD Decree No. 680. Manufacturers may therefore be able to save a significant amount of time and cost for type testing, in case their self-testing report is considered eligible.
1.1. Marketing Authorization Holder (“MAH”) System – New Obligations for Product Registrants:
An essential part of the RSAMD are the new obligations for product registrants under the nationwide adopted marketing authorization holder (“MAH”) system in China. Henceforth, enterprises or medical device development institutions, which hold a medical device registration certificate for Class II or Class III products, or a filing notifications for Class I products, are required to fulfill the new MAH obligations:
● Registrants are obligated to establish a quality management system suitable for the product and shall further formulate post-market research and risk control plans.
● In addition, registrants shall also launch adverse event monitoring and re-evaluation according to the China regulations.
● Furthermore, product traceability and a recall system shall be established and implemented.
● MAHs who sell medical devices registered or filed at their respective domicile or production address, shall not need to apply for a medical device distribution license. Instead, the MAH shall meet the prescribed operating conditions. However, where Class II and Class III products are stored or sold in other places, the MAH shall apply for the related medical device distribution license.
● Generally, it is thereby essential to remember that the MAH/Registrant is now responsible for the safety, quality, and efficacy of the medical device throughout its entire life cycle.
1.2. Clinical Evaluation Requirements and Exemption:
The new RSAMD also brought reforms in the clinical evaluation requirements along with broader exemption from clinical evaluations. Clinical evaluation can now be exempted in case one of the following two criteria are fulfilled:
● (I) A medical device with a clear-cut functioning mechanism, an established design, a matured manufacturing process, the on-market substantial equivalent medical device has no record for serious adverse events and has been marketed and clinically applied for multiple years, while at the same time not having changed its conventional purpose.
● (II) The safety and effectiveness of the medical device can be proven by non-clinical evaluation.
1.3. Enhanced Supervision System and Penalties:
A last key aspect is represented by the strongly enhanced supervision system, which is being further supported by a sharp increase in penalties for committed violations. For medical device violations that occurred before June 1, 2021, the old regulations shall apply. That is, unless they are no longer considered illegal under the new regulations, or are less severely punished under the new regulation, in which case the new RSAMD shall apply. Naturally, for all offenses and violations committed after the implementation date of the new RSAMD (June 1st, 2021), the new regulation applies.
- 2. Decree No. 47 - Administrative Measures for the Registration and Filing of Medical Devices:
The Administrative Measures for the Registration and Filing of Medical Devices was adopted earlier this year on July 22nd, 2021. It will further officially come into force on October 1st, 2021. Decree No. 47 is thereby established in accordance with the above discussed RSAMD, aiming to further regulate the registration and filing of medical devices in China.
Following the RSAMD’s emphasis on making product registration easier for innovative devices, Decree No. 47 further highlights the concept by stating that the NMPA shall give priority to the review and approval of clinically urgently-needed medical devices, while also implementing special review and approval pathways for innovative medical devices (Article 10).
2.1. Special Registration Procedures - Registration Procedures for Innovative Products:
For certain medical devices that meet the following requirements and conditions, the applicant may be eligible to apply for NMPA’s “special innovative product registration procedures” (Article 68). In order to decide whether an applicant qualifies for the special procedure, NMPA will organize experts to review the application. The following requirements shall be fulfilled:
● (I) The applicant legally owns the patent for invention of core technology of the product through its dominant technical innovation activities in China, or obtains the patent for innovation in China, or the right of use through legal transfer.
● (II) The applicant has completed the preliminary study on the product, and the product is basically finalized, while the study process is true and controlled.
● (III) The product and its main working principle is the first of its kind in China, and/or the product performance or safety entails a radical improvement compared to similar products.
2.2. Priority Registration Procedures:
Medical devices that meet one of the following conditions may apply for NMPA’s “priority registration procedures” (Article 73):
● (I) Diagnosis or treatment of rare diseases and malignant tumors with obvious clinical advantages. In addition, products for diagnosis or treatment of unique and multiple diseases of the elderly, while there is no effective diagnosis or treatment method at present. Alternatively, also products used for children with obvious clinical advantages further qualify. Or in cases there is a clinical urgent-need and there is no medical device approved for registration of the same product in China.
● (II) Medical devices that have been listed in the National Science and Technology Major Project, or National Key Research and Development Project.
● (III) Products that are on the priority registration list as stipulated by NMPA.
Parties eligible for the priority registration procedure shall submit the respective application, and NMPA will organize experts to conduct a review. In case the applicant’s request for the priority registration procedure is approved, then during the technical review, the CMDE shall actively communicate with the applicant and may arrange special exchanges when necessary in order to facilitate smooth and quick registration (Article 75).
2.3. Emergency Registration Procedures:
NMPA may implement emergency registration for medical devices that are required for public health emergencies, and that have no similar products marketed in China. Alternatively, also products that have similar products, but whose supply cannot meet the needs for emergency treatment of public health emergencies qualify for emergency registration (Article 76).
Parties eligible for the China emergency registration procedure shall apply to NMPA, and if granted, NMPA shall immediately handle the application for registration. This shall further include early intervention, on-call review, and scientific review and approval. NMPA shall moreover carry out medical device product inspection, system verification and technical review in parallel.
2.4. Change of Registration and Renewal Registration:
In case there are any substantial changes to a registered Class II or Class III product with regards to the designs, raw materials, production process, scopes of application or use methods (which may affect the safety and effectiveness of the product), the registrant shall apply to the original registration department for a change of registration. The applicant shall apply for a change of registration within 30 days from the date of the change (Article 79).
Regarding registration renewals, the applicant shall apply for registration renewal to the original registration department 6 months before the validity period of the Medical Device Registration Certificate has ended (Article 82).
Upon receipt of the renewal application, the Chinese authorities shall make a decision on the registration renewal prior to the validity expiration. If no decision has been made by the time of expiry, the renewal application shall be deemed as having been approved. However, this shall not hold true in the following cases:
● (I) The applicant failed to apply for registration renewal within the specified time limit.
● (II) The new mandatory standards for medical devices have been issued and implemented and the medical devices applying for renewal application cannot comply with the new requirements.
● (III) For the medical device with conditional approval, the items specified in the Medical Device Registration Certificate have not been completed within the specified time limit.
Shall you have any questions regarding the new RSAMD and Decree No. 47, do not hesitate to approach the Qualtech team. We may provide you with further information and an English version of the new Decree No .47 for your review. Furthermore, in case you are interested in registering your products on the Chinese market, please feel free to contact us at your earliest convenience via firstname.lastname@example.org
China’s New Regulation for Supervision and Administration of Medical Devices (RSAMD) – For the moment only available in the original Chinese language version