July 13, 2018
In order for clients to understand the key factors affecting the registration situation of medical devices in China in the last three years (2015-2017), Qualtech has provided an overview and analysis of the medical device registration data (as provided in the following sections of this article), which was released from the CNDA official website. From these data, it’s clear to see that the regulations play a crucial role in influencing the product registration. The abrupt changes in the regulations since the revision of Medical Device Supervision and Management Regulations in 2014 has greatly affected the registration processes of medical devices in China.
In this issue, Qualtech provides an unbiased interpretation of these changes from a regulatory perspective, along with our professional advice in order to aid our clients face China’s rapidly changing market and at the same time, to help them create a distinct place in China’s medical device industry at the soonest possible time.
The Application Number of Imported and Domestic Medical Device from 2015-2017
Figure 1. Number of Applications for Class II and III Imported Medical Devices and IVDs from 2015 to 2017
Figure 2. Number of Medical Device and IVD applications from 2015 to 2016.
From 2015 to 2017, the number of applications of imported medical devices/IVD devices was 5475, 7150, and 4,820 units, respectively, while the application number of domestic medical devices/IVD devices was 3,921, 300, and 2,457 units. From the above data, a significant decrease in the total number of applications per year can be observed as a result of the increased registration fee for imported medical devices which started in May 2015. Nonetheless, slight adjustments have been made on the registration fee for domestic medical device applications leaving the overall numbers unaffected at some point.
The Number of Initial/Renewal/Amendment Application of Imported and Domestic Medical Device from 2015 to 2017
Further analysis on the status of the initial, renewal and amendment applications was made to understand these changes to a greater extent. (CNDA only published the registration information of Class II and Class III imported devices and IVDs)
Figure 3. The number of initial/renewal/Amendment application from 2015 to 2017
The above information visibly reflects the increased number of amendment applications in the year 2016. The possible reason for this is that foreign manufacturers might have tried to bind multiple product models into one registration certificate in order to avoid the preparation of complex technical documents and high registration fee for the initial application.
Secondly, the number of renewal applications for Class II and Class III imported devices has also dropped significantly in the year 2017. This abrupt decrease might be due to the revision of the Medical Device Supervision and Management Regulations which was promulgated in 2014. One section of this guidance has mentioned changes in the validity period of the registration certificate from 4 years (previous regulations) to 5 years which then pushed manufacturers to prepare for the renewal application in advance in order to avoid the expiration of the registration certificates.
Furthermore, with the gradual development of IVD technology in domestic companies, CNDA has issued a number of relevant guidance documents in order for them to regulate the large IVD market and to raise the threshold for IVD registration. This has caused a profound effect on the initial and renewal application of IVD devices/reagents.
Qualtech's interpretation: Increasing model diversity in the market might be a strategic way of changing the scope of registration certificate, however, this solution may not work for all devices. Most manufacturers often oversee the limitations of the scope mentioned in the national guidance, which then leads to the rejection of the amendment application. This further creates a problem as it increases the cost of application and, eventually a lot of market opportunities are missed. In addition, with the increase in the cost of initial application, the manufacturers need to pay more attention on the renewal application and the release of the new guidance/ national standards. If there is any new guidance/ national standards suitable for your devices, then you shall arrange the type testing as early as possible to avoid problems related to these rapid regulatory changes that might possibly hamper the process of renewal application.
Local agents play a key role in medical device registrations with the CNDA. Qualtech provides high-quality representation (agent) service and viable solutions for your product registration. With our real time and up-to-date knowledge on the regulations covering a wide range of medical devices and efficient tracking systems to follow through the renewal status of your registration certificates, you can be rest assured and have full confidence in us that we would handle your product licenses with ease. Please don't hesitate to contact us for further information regarding our services.
The Approval Number of Imported and Domestic Medical Device from 2015 to 2017
In year 2016-2017, the number of imported medical device/IVD device approval were 6440 and 5623 units, respectively, while the number of domestic medical device/IVD devices approved were 2902 and 3300 units.
Figure 4. Number of CNDA Medical Device and IVD approvals from 2015 to 2017
Figure 5. Number of Domestic Medical Device and IVD approvals from 2015 to 2017
The Approval Number of Initial/Renewal/Amendment Application of Imported and Domestic Medical Device from 2015 to 2017
The above information shows the approval status of the initial, renewal and amendment applications. Here, CNDA only published the registration data of imported Class II and Class III medical devices and IVDs.
Figure 6. Number of initial/renewal/amendment approvals for imported medical devices from 2015 to 2017
As the threshold of approval and number of officially implemented guidance documents increases, the number of approvals for import and domestic products also changes. In 2016, the number of guidance documents for official implementation was 52 items and this has significantly affected a wide range of products as well as the registration and approval status in 2017.
Qualtech Interpretation: For both imported and domestic medical devices alike, it is highly mandatory to meet the requirements of guidance documents and national standards. Since 2016, the number of issued guidance documents has exceeded 50 every year, and it is predictable that there will be more and more medical devices to be included within the scope of each document. We recommend all manufacturers planning to enter the China market to take the guidance and national standards into consideration even from the earliest stages of product development and regulatory framework conceptualization. This will not only speed up the time for registration process and increase the approval rate, but also increase efficiency and reduce costs related to the production process.
Qualtech offers professional regulatory research and translation services. Please be welcomed to contact us for more information on these services.
Types of Imported and Domestic Medical Devices in China from 2015 to 2017
Table 1. Product Types of Class II & III Imported Devices Registration
Table 1 lists the top 5 categories of the imported class II and class III devices which have gotten approvals from 2015 to 2017. In the last three years, the main categories were "medical polymer materials and products", "medical electronic equipment", "implant materials and artificial organs", "medical optical instruments, instruments and endoscope equipment", "the equipment and instruments in the operating room or emergency room”, and "oral materials".
Table 2 shows the number of approvals for domestic devices (CNDA only releases data of Class III devices).
Table 2. Product Types of Class III Domestic Device Registration
In the past three years, the main categories were "medical polymer materials and products", "injection device", "implant materials and artificial organs", "medical optical instruments, instruments and endoscope equipment", and "the equipment and instruments in the operating room or emergency room”.
Foreign Countries with the highest frequency of submission applications in the last 3 years
In the last three years, the main countries highly involved in the submission of applications in China are USA, Germany, Japan, UK, and Korea.
Figure 7. Foreign countries with the highest CNDA applications from 2015 to 2017
Although the regulation updates are not as fast-changing as the market news, every update has a profound impact on product launches for each and every country. China has started its regulatory stringency a few years later than other advanced countries, however, China government’s speed in catching up with advanced regulatory strategies can never be underestimated. CNDA also actively participates in the international regulatory organizations. In fact, this year is China’s turn to be the host Chairman of IMDRF. China government has a comprehensive improvement in the global regulatory setting, which shall accelerate the speed of reform of domestic regulations.
Since October 2017, suggestions on having an in-depth evaluation and approval reform has been put into place, along with the FY2018 standard development plan issued in the early 2018 and the revision of the medical device supervision and management which was issued in June. All of the above reforms has made a significant impact in medical device registration. As long as your company plans to enter the China market, close monitoring of dynamic China regulations will be an indispensable work.
Qualtech has established its Beijing office in 2008, and has received the national GCP in 2016 and 2017. We offer one-stop services, including clinical trial services, registration of foreign medical device, and license holding services. We intend to provide you not only professional and efficient medical device regulatory consultations but also strategic solutions by serving as your local authorized representative. We are ready to be your best partner to enter China market and to help you grow your business. Are you ready?
1. The registration report in 2015
2. The registration report in 2016
3. The registration report in 2017