Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

China revises registration procedure for imported and high-risk domestic devices:

This article was originally published in Clinica

Executive Summary

China's State Food and Drug Administration (SFDA) has revised the standard registration procedure for all imported medical devices and domestic class III (highest-risk category) devices. Registration now comprises three elements: application acceptance by the SFDA's administrative service centre; a technical assessment, conducted by its Center for Medical Devices Evaluation; and the SFDA's administrative approval. It also specifies registration criteria and time limits, according to a summary statement issued by the agency on July 30.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT049561

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel