General Administration of Quality Supervision, Inspection and Quarantine 'on some of the imported medical equipment market access issues related to the announcement, "No. 94 of 2008

No. 94 of 2008

On some of the imported medical equipment market access issues related to notice

To further implement the General Administration of Quality Supervision, Inspection and Quarantine and State Food and Drug Administration jointly issued "on the part of the medical device product testing issues related to notice" (State Administration of Quality Supervision, Inspection and Quarantine, State Food and Drug Administration announced in 2006 No. 70) to facilitate the business, share resources, to ensure medical device safety, efficacy and quality control of the premise, according to state laws and regulations, the State food and Drug Administration and the State Administration of Quality supervision, Inspection and Quarantine of the eight kinds of market access for imports of medical equipment reviews some aspects of the merger, thus achieving eight kinds of imported medical devices once detected, an on-site quality system assessment, a fee. The relevant matters are announced as follows:

First, companies should be "eight kinds of imported medical equipment testing organizations directory" (see attachment), select the appropriate testing organization for product testing.

Second, the testing organization registered under the Medical Device product standards and mandatory product certification and implementation rules for the whole term of the relevant product testing, and issue a full-term test report.

Third, the testing organization should effectively in accordance with a test, a fee required to carry out testing work, not repeat testing, recurring charges.

Fourth, the compulsory product certification issued by the factory inspection report as the registration of medical devices submitted by the production quality system assessment report. Factory inspection report shall include the State Food and Drug Administration medical device quality system management and clinical trial data authenticity verifying the relevant requirements.

Notice is hereby.

September 10, 2008