Notice on submission for the registered product standards (trial implementation)
1.Should be consistent with the related regulations of《Administrative methods for medical device standards》.
2.The compiling of registration product standard is in transition stage, implement the requirements of national standard GB/T1.1-2000,《Guiding principles for works in standardization: Part I: Structure and compiling rules for standards》.
3.The requirements in safety standards of the registered product should be consistent with the requirements of corresponding national safety standards.
4.The standard specification indices of the registered product should be equivalent to or higher than those of national/professional standards.
5.The registered product standard, remarks on compilation and organization, and related data submitted should be normal and complete.
6.Specific requirements for submission of imported product standards
(1). Text of standards
(2). Remarks on compilation and organization of the standard and general description of the product, the original data of product technological indices, the basis for determination of administrative class, report on product delivery inspection items or inspection report in third-party pattern.
(3). Certification for marketing document of government approved product (copy).
(4). Proxy for drafting standards.
Note: If the above data were written in foreign language, a translation version should be given.
7.Specific requirements for submission of Class III product standards
(1). Text of the standard
(2). Remarks on compilation and organization of the standard.
(3). Preliminary evaluation results from Drug Administration of the province, autonomous region, or municipality directly under Central Control.
(4). Report on product self-inspection.
8.After completion of the data on registered product standards, submit to Secretariat of State Standardization Technology Committee for Medical Devices for review.
9.In the period of review, if it was informed to the applicant for amendment, supplement data or explain questions, the waiting time will not be included in the time limit. During this period, the time limit of review will be correspondingly prolonged.
10.For the ways taken in signature and stamp of registered product standard, the related requirements in Guo Yao Jian Xie [2001] No.478. are implemented (See website: www.cmdi.gov.cn).