The Chinese medical device industry has experienced significant growth, with reported revenues of RMB 1,171 billion in 2022, up from RMB 530 billion in 2018 (see Figure 1). The industry saw a rapid surge in demand for various medical devices in the last three years due to its rapidly aging population and increasing healthcare spending.
The medical device market in China presents a significant opportunity for manufacturers, but it is essential to understand and navigate the complex requirements and multi-step process. Familiarity with the process can streamline the submission process and improve the efficiency of bringing products to market. In this regard, we discuss some requirements which should be considered when submitting a device to the National Medical Product Administration in China.
Figure1: Size of the medical device market in China from 2018 to 2022 with an estimate for 2023 (Adapted from Statista.com: Published by Wenyi Zhang,Dec 1, 2023)
NMPA and the basic law for Medical Devices in China
The National Medical Product Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA), is the regulatory body responsible for overseeing medical devices in China. Before medical devices can be sold or distributed in China, manufacturers are required to register their products with the NMPA. Manufacturers must follow the current Provisions for Medical Device Registration and Filing (Decree No. 47, issued on August 26, 2021 and gone into effect as of October 1, 2021), which were formulated in accordance with the Regulations on Supervision and Administration of Medical Devices. The purpose of the Provisions is to standardize the registration and filing processes for medical devices, as well as ensure the safety, effectiveness, and quality of medical devices. The Provisions apply to the registration, filing, supervision, and administration of medical devices within the territory of the People’s Republic of China.
Determination of Medical Device Classification
In the “Rules for Classification of Medical Devices” published by the NMPA, medical devices are divided into class I, II and III based on their risk levels as outlined in following Tables 1 and 2. One criterion that differs substantively from the European Classification is the duration of contact. Those durations are similar to those stipulated in ISO 10993-1 and therefore temporary use means up to 24 hours instead of only 60 minutes.
Table 1 Rules for Classification of body-contacting Medical Devices
Table 2 Rules for Classification of non- body-contacting Medical Devices
Guidance to the tables 1and 2:
- “I”, “II” and “III” herein respectively refer to class I, II and III medical devices.
- “-” herein means the situation is inapplicable to any class of medical devices.
- Those tables originate from the NMPA website.
Procedures for Approvals of Imported Medical Devices in China
Pursuant to Articles 2 and 5 of the Provisions for Medical Device Registration, any medical devices intended for sale and use within China must undergo either a registration or filing process. According to Article 5, the NMPA’s Center for Medical Device Evaluation (CMDE) is responsible for overseeing technical evaluation of registration applications, change registrations, and renewal applications for domestic Class III and imported Class II and III devices as well as the clinical trial approval process for devices requiring clinical trials.
Class I medical devices are subject to a filing requirement, as outlined in Article 6.4. In contrast, Class II and III medical devices necessitate full registration, along with an inspection of the manufacturer’s quality management system, as detailed in Articles 3.1 and 6.2. For imported medical devices, applications must be submitted directly to the NMPA. Foreign applicants are required to designate a Chinese agent to handle communications with the NMPA and fulfill other regulatory obligations, as stipulated in Article 14. Additionally, Article 17 of the Provisions mandates that all submission materials be in the Chinese language. If original documents are in a foreign language, both the original and Chinese translated versions must be provided.
In the following table 3, procedures for approvals of imported medical devices in China are summarized:
Table 3 Procedures for approvals of imported medical devices in China
Application requirements in China as per Medical Device Class
Applying for a medical device license in China in general requires involvement of a Chinese agent that must be mandated as per Article 14.
In addition, applicants should make sure that their products conform to applicable mandatory standards in China as per Article 19 of the provisions. Especially drafting the product technical requirements is a tough task for a lot of manufacturers when it comes to preparing the application. As per article 26 of the provisions “Product technical requirements mainly include the functional and safety indicators and test methods that can be objectively determined for the finished medical devices.” and products need to comply with those requirements over the whole period of registration validity. This aspect differs from the European approach of “State of the art” and can cause problems when re-registering.
In general, the following documentation needs to be submitted depending on the medical device class:
Class I:
According to Article 14 of Chapter II Registration and Filing of Medical Device Products of “Regulations for the Supervision and Administration of Medical Devices”, the following documentation should be submitted for the filing of class I medical devices:
- risk assessment documentation;
- product technical requirement;
- product test report;
- clinical evaluation documentation;
- product IFU and label sample;
- quality system documentation related to product development and manufacture;
- other data to demonstrate the product safety and efficacy.
Class II and III
Manufacturers are required to submit an application file for medical devices classified as II and III. This application file must include the following sections:
- Application form
- Qualification files
- Basic requirement list for the safety and efficacy
- Summary information:
- Overview
- Product description
- Models and specifications
- Packaging description
- Intended use and contraindications
- Equivalent product
- Others
- Research data
- Performance
- Biocompatibility
- Biological safety
- Disinfection and sterilization process
- Shelf life and packaging
- Animal studies
- Software
- Others
- Manufacturing information
- Manufacturing process
- Manufacturing sites
- Clinical evaluation
- Product risk assessment
- Product technical requirement
- Registration test report
- Test report
- Pre-evaluation conclusion
- IFU and labels
- IFU
- Label samples of units for sale
- Declaration of conformity.
Especially in case of Class II and class III applications, the requirements should not be underestimated when it comes to product testing / type testing in China. Having to perform product testing / type testing requires establishment of the product technical requirements and submitting product samples to an NMPA acknowledged test center. Results of these test may have an impact on the overall timeline and content of the application submission. One should also consider that type testing is also necessary in case of re-registrations, especially if the mandatory Chinese standard had been revised in between.
Upon receiving approval from NMPA, the registration for Class II and Class III products is valid for 5 years.
Registration renewal should be started in a timely manner, keeping all the requirements in mind. In addition, manufacturers should assure that changes that cannot be submitted within re-registration files are submitted separate. This may for example include changes to the technical requirements or component and structure of the device.
Clinical Evaluation and Investigation
According to Article 34 of the current “Provisions for Medical Device Registration”, clinical evaluation has to be performed for all medical devices, unless the product is on the exemption list, or it applies one of the following criteria:
- Where the functional mechanism of the device is definite, the design is finalized, the manufacturing process is well-established, the marketed predicate device has been in clinical use for years and no serious adverse events (SAEs) are recorded, and its regular intended use is not changed.
- Where the safety and effectiveness of the medical device can be proven through non-clinical evaluation.
The NMPA maintains a catalogue of medical devices that are exempt from the clinical evaluation requirement. As per Article 35, clinical evaluation for a medical device can be satisfied by either conducting a clinical trial tailored to the product’s characteristics and risks, or by analyzing relevant clinical literature and data from predicate devices.
In cases where the existing clinical literature data and clinical data are insufficient to validate the safety and effectiveness of the products clinical trials are mandated. Any such trials must adhere to the Good Clinical Practice (GCP) standards and be carried out at a qualified clinical trial institution that has been properly registered. Clinical trials for High-risk devices within China are subject to NMPA approval and must be conducted within qualified tertiary A medical institution. The manufacturing of medical devices used in clinical trials must comply with the relevant Good Manufacturing Practice (GMP) requirements for medical devices. Clinical trials conducted abroad may be subject to additional domestic review.
Have you already familiarised yourself with Chinese requirements and would like to find out more about this interesting market? We are happy to accompany you on this exciting journey, both for the preparation of the submission documentation and for overcoming cultural misunderstandings or differences.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
