Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

China Predicate Devices

Predicate Devices, also locally referred to as “Same-Type” devices in China, are an important aspect of National Medical Products Administration (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 began their review process. This lack of transparency historically caused significant issues for manufacturers trying to enter the lucrative Chinese market on a budget. At present, 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 is 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. This reduced 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, 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 in the summer of 2019 outlining the formal process for seeking the performance parameters expected during the product’s application process.

While there previously had been a mechanism for asking the China FDA 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.  

India Predicate Devices

The definition of a “predicate device” in India as per the Medical Device Rules, 2017 is as under: 

Section 3, Definitions: 

(zm) “predicate device” means a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for license in India.” 

In addition to risk classification and grouping, the cost and time required to register a medical device in India is influenced by the existence of a registered predicate device on the market. If a medical device is seen by the regulators as having a predicate device registered in India, then a standard Form MD-14 (Import License) application process is followed. 

However, if a medical device is considered as not having a predicate device registered in India, then pre-market, or post-market clinical data from India may be a required element of the registration application. This will be determined on a case-by-case basis by Subject Expert Committee (SEC) review. SECs are formal meetings with technical specialists representing the CDSCO and product specialists from the manufacturer.

During the meeting, the manufacturer will provide evidence for their device’s safety and efficacy and answer the SEC’s questions. Once complete, the SEC will provide additional requirements to be performed before, or after, the (MD-15) Import License is issued.  

Predicate Devices as Part of the Registration Process

After a rule was put into effect on October 1st, 2021, all medical devices in India have to be Registered with the Central Drugs Standard Control Organization (CDSCO). Additionally, specific product categories, called Notified Devices, have to obtain an Import License prior to importation. Registration of Non-Notified devices do not currently require the identification of predicate devices to register.  

However, since the registration regulation landscape is changing in India, (including the necessity for all Class C and D devices to be Notified by October 1, 2023), all manufacturers will need to identify a predicate as part of maintaining market access in the near future. In addition to identifying a predicate, the CDSCO will also want to see that the product has been approved in the country of origin, also known as Reference Country Approval.

Technically, all first applications for each product category of non-Notified devices will not have a registered predicate on the market (as registration was not required). This situation could potentially require many clinical studies be performed in India.

To alleviate some of the burden, devices that have been registered in a reference market (the US, Europe, the United Kingdom, Japan, Canada, or Australia) with sales data for more than 2 years will be exempted from the local clinical data requirement.