Being a local agent for medical device products in China is going to get significantly more rigorous. Some of the new requirements now in draft form, will be implemented soon.
According to the new regulations, the NMPA organized the drafting of “Measures for the Supervision and Administration of Imported Medical Device Agents (Draft for Comment).” Some of the key new requirements for local agents include:
- The local agent should have a quality management system suitable for engaging in agency work, having quality management personnel or quality management institutions corresponding to their scale, and the quality management personnel should have the ability to perform the corresponding quality management duties
- The local agent for Class III medical devices shall have a computer information management system that meets the traceability requirements of the products
- The local agent should know the sales and distribution of such products in China to ensure the traceability of products
- The agent shall be held jointly liable with the overseas medical device marketing license holder for product quality and related service violations
- The local agent shall regularly conduct self-examination on their own operation, fulfill their legal obligations, and submit an annual self-examination report to the local provincial drug regulatory authority before the end of each year