Real World Data Clinical Guideline Published Today; China Med Device Pioneered in the Program

NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)” today (December 13, 2019). Feedbacks need to be submitted by January 13, 2020.

Eight overseas manufacturers participated in the Hainan RWD program piloted since June 2019, including one represented by Bradynuoen, a regulatory and clinical affairs consulting firm with offices in Boston and Beijing.

As a cost-effective and less time-consuming alternative to the traditional clinical trial, “RWD will be explored for regulatory decision-making in order for accelerated medical device innovation and market introduction.” NMPA stated in today’s notice.

When to Consider RWD?

The RWD Guideline contains the following sections:

1. Summary
2. Data source and categories
3. Elements for quality evaluation
4. Research design principles, common types and statistical analysis methods
5. Situations to consider RWD

In the last section, NMPA lists 11 examples to use RWD as a means of clinical evaluation:

1. Provide clinical evidence for products in same variety
2. Support product registration as a supplement to existing evidence
3. Support extension in application scope and intended use
4. Support post-market research for products with conditional approval
5. … …

For English version of the “Guideline on Real World Data Used in Medical Device Clinical Evaluation (Draft)”, please email info@inspirativemed.com. We charge nominal fees for the translation.

Another Clinical Pathway

Real World Data will become another clinical pathway for device approval in China. Overseas manufacturers can obtain approval for the RWD pilot program through Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval. This is especially significant for manufacturers with high price tags, as RWD program participants can generate clinical data in the actual clinical environment with service fees whereas the traditional clinical trial needs to be complimentary.

Hainan is the first province to pilot Real World Data in China. It offers an additional clinical option to the currently available clinical pathways such as clinical evaluation report and overseas clinical data acceptance. As RWD can be used prior to national NMPA approval, it can significantly shorten the time to begin selling devices in China.

Certain protocols and guidelines need to be followed for the RWD to be admitted as part of the clinical evidence for submission.

Five Advantages in Hainan

RWD is the second major policy incentive for overseas manufacturers going into Hainan. The first is the status of ‘first independent province for imported medical device approval’. “Imported medical devices can be clinically used in Boao City, Hainan province without national NMPA registration approval, as long as they are approved by Hainan Province NMPA office”, announced by China State Council on April 4, 2018.

In addition, national NMPA announced three policies for Hainan on December 11, 2019:

1. Apply Market Authorization Holder (MAH) system
2. Establish considerable number of NMPA-filled clinical trial sites
3. Establish the first provincial medical device review center

Bradynuoen is honored to be pioneering in the Hainan RWD program, and our client who participated in it will benefit from the new policies. To determine if your devices & IVDs fall into the RWD catalog, please email us at info@inspirativemed.com.