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.