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Regulations on the Management Measures of Medical Devices and in Vitro Diagnostic Reagents Are Imple

  Author:MeCan Medical–ultrasound machine manufacturers

The newly revised "Administrative Measures for the Registration and File of Medical Devices" and "Administrative Measures for the Registration and File of End Diagnostic Reagents" (hereinafter referred to as two measures) will be implemented from October 1 this year. On September 29, the Pharmaceutical Bureau issued a notice to explain the two methods.

According to the notice, the registration application projects that have been accepted before the implementation of the two methods but have not yet made a decision of approval. The pharmaceutical supervision and management department continues to review and approve the approval in accordance with the original regulations. The registration application projects that have been accepted before the implementation of the two methods but have not yet made the approval decision. If the correction materials involve the inspection report, the registered applicant shall entrust a qualified medical device inspection agency to issue a supplementary inspection report; if the registered applicant's system verification covers the coverage The inspection ability can also submit supplementary self -inspection reports in accordance with two methods and related requirements.

The announcement pointed out that for the mandatory standards cited in the product technical requirements of the registered medical device, in addition to the other regulations in the implementation of the implementation standard documents, the registration of the implementation of the new standard will be accepted. Examination and approval shall be conducted in accordance with the original standards.

From the date of the implementation of the new standard, enterprises shall fully implement new standards, and products shall meet the requirements of new standards. Regarding the biology test of medical equipment, the announcement pointed out that the biological test report involves biological tests in the evaluation of medical device, and the biological test report shall be submitted by the applicant as a research data when applying for registration.

To carry out biological tests, the medical device testing agency with biology test qualifications shall be entrusted to conduct tests in accordance with relevant standards. The biology test report issued by foreign laboratories shall be attached with a foreign laboratory that indicates that it meets the quality assurance documents required by the GLP laboratory.

Regulations on the Management Measures of Medical Devices and in Vitro Diagnostic Reagents Are Imple 1

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