The former State Administration of Pharmaceutical Affairs has issued "on the issuance of & lt; 〖HT4F〗GB 9706.1-1995 standard implementation and supervision and inspection of the work plan & gt; notice" (State Drug Administration [1997] No. 275). Notice GB 9706.1-1995 standard is broken down into 110 items, and provides for product registration, licensing and cycle inspection should include at least 61 of the type test items. In view of the GB9706.1-1995 standard is a mandatory national standard, in order to ensure the safety and effectiveness of listed medical devices, is now registered medical electrical equipment products to implement the GB 9706.1-1995 standard matters related to the notification are as follows:
One of the manufacturers should ensure that the listing of medical electrical equipment products are safe and effective, do not meet the mandatory national standards or industry standards for medical electrical equipment, the product should not meet the requirements of the national standards or industry standards. National standards or industry standards for medical electrical equipment shall not be listed for sale.
Second, from the date of issuance of the new application for registration of medical electrical equipment, the applicant should submit an application for the product meets the GB 9706.1-1995 standard for the full registration test report. If the applicant can provide the application product has been in line with the GB 9706.1-1995 standard self-test report or the full test report of the testing organization, the product registration test can only be carried out in the State Drug Administration word [1997] No. 275 of the 61 items specified in the text.
Third, has been accepted but not yet obtained a registration certificate of medical electrical equipment (including re-registration of the product), the applicant can not provide the application product has been in line with the GB 9706.1-1995 standard self-test of the full report or the full report of the testing organization, the applicant is required to GB 9706.1-1995 standard does not detect the project to supplement the registration test; if the applicant Can provide products have been in line with GB 9706.1-1995 standard self-test full report or full test report of the testing organization, can no longer supplement the registration test. The above cases are required to not fully implement the GB 9706.1-1995 standard registered product standards for revision.
Four, has obtained a product registration certificate of medical electrical equipment, the applicant should be in December 31, 2007 to the registration department in charge of supplementing the product in line with the GB 9706.1-1995 standard self-test of the full report or the full report of the testing organization's test report.
V. After the release and implementation of this notice, it is too late to re-register the medical electrical equipment, medical devices at all levels of the registration department can extend its registration certificate until December 31, 2007 at the longest.
Sixth, the applicant to provide products in line with the GB 9706.1-1995 standard of the full self-inspection report, the enterprise's ability to test need to be verified by the competent authority for registration.