Rules on registration-testing for medical instrument imports issued

Regulations on Registration Testing for the Import of Medical Instruments were passed by the State Drug Administration (SDA) on March 14, 2001, with effectiveness on the same date.

To ensure safety and effectiveness of imported medical instruments, special testing and verification needs to be carried out before registration with SDA could be made.

Medical instruments under the Regulations refer to those for which approval certificates have been granted for their entering into the market in their countries of origin.

SDA-delegated testing organisations are responsible for the reviewing of the standards of registration, carrying out testing against such standards and issuing test reports.

For further information please contact Luke Filei on luke.filei@cms-cmck.com or +86 10 6590 0389 in Beijing or +86 21 6289 6363 in Shanghai.