China NMPA Issues Medical Device Sampling Plan

In an effort to improve the quality of medical devices on the Chinese market, the NMPA, led by the National Institutes for Food and Drug Control (NIFDC), will do sampling inspections at various healthcare facilities. Sixty-six product types will be sampled including products like hydrocolloid dressings, dental implants, carbon dioxide laser machines, breast implants, etc. Samples will be tested from hospitals, clinics, warehouses, and distribution channels. Testing criteria include the Technical Product Requirements and required device standards.

The sampling inspection will occur every year going forward from June to August. Samples selected will be tested by testing institutions under the supervision of provincial NMPAs. The NMPA will then publish a list of products that fail the sampling. If a manufacturer fails the sampling test for 2 or more consecutive years, a specific factory audit will be triggered. The testing fees are covered by the Chinese government.

In addition to the national sampling inspection, each Chinese province will also formulate its own annual sampling inspection plan and product list which is different than the national sampling plan and normally occurs 1-2 months after the national sampling plan. If a company does not facilitate or provide the necessary information for a sampling inspection, it may result in a listing in the Enterprise Credit File which will likely require a re-inspection.