If you are a manufacturer interested in accessing the Chinese medical device market, Asia Actual has an active list of devices exempt from Clinical Trials along with experienced professionals that can help you determine whether your product will require a trial.
Predicate Device Identification in China
Predicate Devices, also sometimes referred to as ‘Same-Type’ in China, are an important aspect of NMPA applications. Products unable to successfully identify and show similarity to an already approved device will often require expensive in country clinical trials as part of the approval process. While the NMPA releases annual updates to their Clinical Trial Exemption list, manufacturers can also sometimes avoid clinical trials by providing a sufficient comparison to a similar product along with a robust Clinical Evaluation Report. This aspect of the application process in China has long plagued medical device manufacturers as the requirements often remained unclear until reviewers actually began their review process. As this lack of transparency was causing significant issues for manufacturers trying to enter the lucrative Chinese market on a budget, the NMPA has become more diligent in releasing clinical trial exemption lists and has even opened up an online pre-submission process for borderline products to help clarify expectation.
“SAME TYPE DEVICE” AND CLINICAL REQUIREMENTS
In recent years, some foreign manufacturers have become frustrated with China’s regulatory requirements due to their inability to understand, and plan for, what will be needed during the application process. One of the primary uncertainties is whether a device will require local clinical trials. Previously, the NMPA (CFDA at the time) were more lenient with clinical requirements and would accept Clinical Evaluation Reports (CERs) in lieu of clinical trials, thus reducing the registration costs significantly. However, as the Chinese medical device industry continues to rapidly expand, the NMPA has sought more oversight. When combined with their very narrow definition of a predicate, or locally known as “same type device,” it can be difficult for foreign manufacturers to determine ahead of time how their product will be evaluated.
In order to alleviate some of the uncertainty facing manufacturers of same type devices, the NMPA published a notification (link in Chinese) in the summer of 2019 outlining the formal process for seeking the performance parameters the NMPA would expect during the product’s application process. While there previously had been a mechanism for asking the CFDA about this issue, the new process is more transparent and is expected to cut the turnaround time from about 6 months to 2 months. Depending on the NMPA’s feedback, manufacturers can then compile a Clinical Evaluation Report (CER) in lieu of a Clinical Trial to support their same type device claim.
How to Identify a Predicate Device in China
In order to identify a predicate device in a country, the manufacturer must first identify similar products. These products will need to use similar technology and have the same indications for use. For example, a drug eluting coronary stent cannot use an ordinary coronary stent since the product doesn’t use a drug. Furthermore, for a drug eluting stent to use another as a predicate, it would also need to use the same drug in similar quantities. Furthermore, the indications for use must also be similar. They don’t have to be exact but the predicate’s indications for use must cover the applicants.
One of the best ways to identify similar products is to identify competing products, especially those that are at larger companies or have been around a while. This will increase the likelihood of these products being registered internationally and in more markets. If manufacturers can compare their products to the same product in each market, it can significantly reduce the overall regulatory burden. Then, once the manufacturer has a list of potential predicate devices, they will need to confirm that these products are actually registered in China. To do so, the manufacturers can work with a local partner to conduct this research, search the NMPA’s database, or use Asia Actual’s Registration Optimized Search Engine (R.O.S.E.) which aggregates registered products from public databases throughout Asia, including China.
Registration Process Overview in China
Medical device product registration and importation in China requires a Medical Device Registration Certificate (MDRC) issued by the National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA). This document is technically owned by the foreign manufacturer, but is controlled by the Legal Agent listed on the certificate who is responsible for the registration application. Products must have home country approval prior to applying for registration in China.
Medical device registration in China is now valid for 5 years (previously it was valid for only 4 years). If a manufacturer wants to renew a device’s registration, a renewal application should be submitted 6 months prior to the expiration date and can now be submitted online through the new Electronic Regulated Product Submission (eRPS) system, along with all new applications. For the most up to date information on the registration process in China, please see our Medical Device Registration page.
Asia Actual Can Help Identify Predicate Devices in China
Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the Chinese market. Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in China. Regulatory professionals can also use Asia Actual’s new regulatory tool, R.O.S.E., which allows users to search registrations across multiple markets all at once and in English. Click here to learn more.
China Regulatory Support
US: +1 512 898-9222
SG: +65 3138-4148
Latest Market Updates
What is R.O.S.E.?
R.O.S.E. is Asia Actual’s new tool for empowering RA professionals by allowing users to search multiple countries all at once in English. Users can search by product name, manufacturer, brand, product categories and more. Not only does R.O.S.E. help RA professionals find predicates, it can also help classify products and monitor competitors. Then once your products are registered, you can keep track of your registrations and get reminded when they’re due for renewal.
As of April 2022, R.O.S.E. provided members with access to registrations in:
- China – Imported Products
- Hong Kong
- China – Domestic Products (coming soon)
- Taiwan (coming soon)
- India (coming soon)
- USA (coming soon)