Any class II and III medical device manufacturer or distributor in China should apply for and obtain the “Medical Device Manufacturing Enterprise License” or “Medical Device Distributing Enterprise License” from provincial or municipal food and drug administration bureau. There are only required to submit record keeping to local medical device authorities for class I medical devices manufacturing and class II medical device distributing.
The license of manufacturing and distributing enterprise is valid for five years. Companies are required to renew the license prior to six months of expiration.
- Class I medical devices can be exempted from license for manufacturing, but record keeping is required so as to ensure the product safety and quality control.
- Class I and class II medical devices can be exempted from license for distributing, but the record keeping is required for class II medical device.
Note: The manufacturer or distributor of medical devices exempted from license should meet the requirements of quality management system in China.
Please join in our “China Medical Device Regulatory Assistant Program” for free proposal. For complex and urgent projects, we will assign a dedicated project manager to customize a program specific to your requirements. We are ready to be of service at any time.
Mr. Edwin Wen China office
Tel: +86 571 8720 6541 | Fax: +86 571 8720 6533
Mr. Michael Petersen China office
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533