【EXPERT Q&A】Is there a requirement for the registration address of the second type of medical device business filing?
March 12, 2024
Source: drugdu
91
Drugdu.com expert's response:
There are usually requirements for the registered address when applying for the record-filing of the distribution of Class II medical devices. The registered address is typically required to be a legally operated premises that complies with relevant regulations, ensuring that the storage, sales, and management of medical devices meet the standards. Specific requirements may include the area of the premises, environmental conditions, storage facilities, safety measures, etc.
Copyright©2024 Ddu. All rights reserved.
Read more on
- 【EXPERT Q&A】What does the 4-digit number next to the CE mark on medical devices mean? May 16, 2024
- 【EXPERT Q&A】What does FDACFR21 in the United States refer to? May 13, 2024
- 【EXPERT Q&A】What is OTC? What products do FDA need to apply for OTC? May 8, 2024
- 【EXPERT Q&A】What is CAPA for Medical Devices? May 6, 2024
- 【EXPERT Q&A】What is the relationship between FDA registration and 510K registration for medical devices and what is the difference? April 30, 2024
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
