Comparison of Medical Device Emergency Management Process between China and the United States
In responding to the COVID-19 epidemic, all countries urgently established their green pathways for the emergency approval of medical devices. Both the medical device emergency approval process in China and EUA authorization in the US are special evaluation systems established in response to major emergencies. Both have similarities and differences, as shown in the table below.
Link: https://www.cmde.org.cn/CL0033/21193.html
| Items | US | China |
| Expiration date of emergency product | The Ministry of Health will announce that the EUA will be invalidated from the date of termination, or the product will be invalidated due to cancellation. | According to the characteristics of the product, the validity period of the certificate is temporarily defined as half a year or one year. |
| After the emergency product certificate expires | EUA products can no longer be used after the certificate has expired. If the product needs to be used continuously, a regular application is required. | When the certificate is renewed, if the post-marketing research data can be submitted on time and meet the marketing requirements, it can be renewed. |
| Applicant | Government departments (such as CDC), manufacturers, or laboratories. | Manufacturers (products of government departments are not regulated by NMPA). |
| Communication before Application | EUA has a pre-EUA pre-application mechanism | Pre-application communication mechanism |
| Product Performance | The “effectiveness” turns to “possible effectiveness”. The evidence level is lower than the FDA standard effectiveness criteria of regular marketing approval, but the benefits still outweigh the risks. | The standard shall not be lowered, and the conditional approval requires the manufacturers to supplement the research data within a time limit in the form of. |
| QMS | Exempt some quality management system requirements (including design, production, packaging, label storage and sales, etc.) | Still need to carry on the system inspection, which will be carried on parallel with the technical review |
| Fee | Charge | Free |
