Drugdu.com expert's response:

In the production and sales of medical devices, countries have strict laws and regulations to regulate them.

Taking China as an example, the Measures for the Supervision and Administration of Medical Device Production are formulated to strengthen the supervision and administration of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices.

The measures clarify the laws, regulations, rules, mandatory standards and quality management specifications that should be observed in medical device production activities, and require medical device registrants and filers to be responsible for the safety and effectiveness of listed medical devices.

At the same time, according to the different levels of medical device risks, China also implements classified management for medical device production, requiring enterprises engaged in different types of medical device production to obtain corresponding production licenses or make filings according to law.

In addition, the country has also strengthened the information construction of medical device production supervision and management, improved the level of online government services, and promoted the sharing of information on medical device production supervision and management.