【EXPERT Q&A】How to handle the Class II medical device management record, what materials need to handle?
March 15, 2024
Source: drugdu
139
Drugdu.com expert's response:
To apply for the record-filing of the distribution of Class II medical devices, the following materials are usually required:
1.Copy of the enterprise's business license;
2.Medical Device Distribution License;
3.Identification of the legal representative;
4.Product registration certificate or record-filing certificate;
5.Quality management system documentation for medical devices;
6.Labels and instructions for medical device products;
7.Qualification certificates for sales personnel;
8.Proof of relevant premises use;
9.Other relevant documents that may be required.
The required materials may vary depending on specific local requirements and regulations. It is advisable to consult the local medical device regulatory authority for the latest application guidelines and the list of required materials before proceeding with the record-filing process.
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