China issues more overseas medical device and drug inspection regulations

In a sign that China intends to increase its scrutiny of foreign medical device and drug companies, its regulators are instituting a process for inspecting overseas medical manufacturing facilities.

The new guidelines announced in late December by China’s National Medical Products Administration (NMPA) are intended to standardize its approach to the inspection of foreign manufacturing facilities. China has ramped up its oversight of overseas device and drug companies in recent years, but to date has not had established procedures to verify whether foreign drug and device companies’ R&D and manufacturing activities adhere to the nation’s statutory requirements and standards. These new guidelines do just that.

The inspections will be performed in accordance with NMPA risk assessments and are designed to ensure the reliability and safety of devices approved or intended for marketing in China. Inspectors will seek assurances that actual manufacturing processes are consistent with those registered with the NMPA. Inspections may include relevant secured technical files, R&D partners and other vendors hired by the overseas firms.

Inspections may result in requiring corrective action. Penalties include rejection of product license renewal, product recall, suspension of import and sales, and warning letters. For severe deficiencies, the NMPA would order manufacturers to suspend importation and sales of their products in China.