September 17, 2018
The requirement for NMPA (formerly CFDA) registration documentation was derived from No. 43 directive. It is divided into 12 distinct parts, wherein the 3rd to 11th parts include technical documentations with the following main sections (a) the safety& effectiveness checklist (b) summary of the device (c) research study (d) manufacturing process, (e) clinical evaluation study (f) risk management report (g) technical requirements (h) test reports, and (i) IFU and labels.
For this issue, we will be introducing the concept of NMPA’s technical documentation and a short overview of each of its major parts. NMPA regulates the medical device in a strict and conservative manner. In fact, NMPA has released a number of guidelines and standards (from the previous big topic in the July issue, it has been mentioned that NMPA has been publishing more and more product guideline from 2015, which cover for over more than 200 products). Taking No.43 directive as an exception, the applicant is responsible for the close monitoring of each and every requirement in the published guidelines and standards related to the device being applied.
I. “Safety and effectiveness checklist” should provide a summary table for the evaluation of the device in question. The manufacturer shall fill in the required information as specified in the checklist and shall supply the corresponding documentary evidences. For some items that are not applicable, the applicant shall justify why this item is not applicable.
II. “Summary of device” is an overview of the applied device, which shall focus on the introduction of the device, and description of similar (predicate) device to let the reviewer understand the device being applied for. This document is very important as the content of document would provide reviewer the main focal points for device evaluation.
III. “Research study” comprises a major component of the documentation and includes several test reports providing evidences of the device’s overall functionality. This also contains a summary of each performance report. This document contains several parts, namely: 1) Product performance, 2) Biocompatibility, 3) The safety of animal-derived material, 4) Sterilization and disinfection, 5) Stability and package, 6) Software, 7) Pre-clinical animal studies, 8) Others.
IV. “Manufacturing process” describes how the applied device is being produced. Its content shall include the whole processing, outsourcing, and key processing.
V. “Clinical evaluation study”. There are 3 main routes followed for the clinical evidence report: 1) the device exempted for clinical trial, 2) the clinical evaluation report (CER), and 3) clinical trial study. NMPA has published four (4) notices, each containing a list of specific medical devices that are exempted from the clinical trial. If you don’t intend to conduct clinical trials in China, and the device you would like to apply has a predicate device registered in the same, maybe CER is an applicable pathway. However, since it’s China’s turn to be the host chairman of the IMDRF and they begin focusing on the evaluation of clinical evaluation reports, then it should be expected that the product guideline would also be including CER as a requirement for device registration. If your device does not qualify in either of these two pathways, then clinical trial shall be required. Before proceeding with registration in China, it’s better to know in advance which route shall be deemed applicable for your device.
VI. For “risk management report”, every medical device has its own risk and benefit. Every manufacturer shall make a thorough analysis and management for all risks associated with the medical device. The risk management report is required in NMPA technical documents. With its highly developed post-market surveillance protocols, NMPA has obtained many adverse event reports on several medical devices. NMPA will take all the root causes of the adverse event into consideration and will ask the applicant to include these into the risk management report as well. It’s better to follow the recall situation of similar devices in China.
VII. There is a unique document which covers a description of all performance parameters of the applied device. This document is referred to as the “technical requirement”. The technical requirement contains all the performance requirements of device, including the test methods used, which is another critical part of the next document – the Test report. NMPA has published numerous national and industry standards, some of which were derived from international standard, and some were originally drafted by NMPA. If your device has to follow the original standards formulated by NMPA, then you have to take this standard as reference, otherwise, the test item in this standard might affect your registration progress.
VIII. “The instruction for use (IFU)” is a key point for NMPA. NMPA has also issued the No. 6 Directive which is a directive aimed at regulating the IFU and labelling. The IFU shall include relevant information on the basic safety and effectiveness for the intended users. In addition, IFU shall offer technical information pertaining to device, such as installation, calibration, operation, usage, and maintenance.
Comparison of STED and NMPA
The NMPA’s technical documentation is similar to STED however, some notable differences lie on the content required for each document. These differences are summarized in the following table:
How to harmonize the STED into CSDT and NMPA documentation?
From the above comparison table, it’s quite noticeable that the structure of these three types of documentation are similar, but the detailed requirements are different. The STED is the basic requirement on every document, and ASEAN and NMPA refers to STED to build up their registration submission documentation. When your company decides to access either ASEAN or China or both markets, it’s a better way to use STED as the internal structure and incorporate the local regulation/ directive/ guideline/ standard into the structure. This action helps you understand the local requirement, and caters for easy management of your registration documents. Further, you may also check if there are any special requirements in the local countries. If yes, then you should take these as priority.
The concept of harmonizing regulatory requirements is becoming a trend. From STED and MDR to the current AMDD and MDSAP, the harmonization scope covers almost all aspects of the registration system and manufacturing system. How to catch up with the core regulation is an important issue. You have to understand the core requirement, then comply with the local requirements based on the market strategy of your company.
More and more countries use and modify the STED and incorporate them into their respective national regulatory systems. STED shall be the core structure in every company’s registration system.
In this article, we have introduced the STED, CSDT and NMPA’s technical documentation. Furthermore, we have outlined the major differences among these three systems. We hope that this article would be of help for our clients in organizing their internal documentation in order for them to efficiently process their registration applications in ASEAN and China.
We cater to offer our clients with “single documentation service for multiple country registration” in order to assist you in registering your device and eventually access Asia market in the same time. Qualtech has established offices in China, Japan, Malaysia, Philippine, Indonesia, Vietnam, Singapore, HongKong, Taiwan. With our thorough understanding of the local regulations for General medical devices and IVDs in the aforementioned countries, we also take pride in our capability to harmonize each of the local regulations and incorporate them to our internal process. With excellent trainings and effective teamwork, you can put your confidence in us that your registration progress for each country is efficiently carried out and easily followed up.
Feel free to contact us to know more about this service.
1. NMPA directive No.4,
2. NMPA directive NO.6,
3. NMPA directive NO.43