The new Measures for the Administration of Registration of Medical Devices (Order No. 4), which came into force on October 1, 2014, has been revised and improved on the basis of the old regulations. The third chapter of Order No. 4, Product Technical Requirements and Registration and Inspection, changes the name from "Product Standards" to "Product Technical Requirements", streamlines the content of Product Technical Requirements and adds new pre-evaluation requirements. For this chapter, the medical device product standards and technical requirements to make a comparison:
Medical device product technical requirements and product standards for comparison
Decree No. 4 clear: product technical requirements mainly include finished medical device performance indicators and test methods, which performance indicators refers to the finished product can be objectively determined by the functionality, safety indicators and other indicators related to quality control. Related to other indicators.
As early as May 30, 2014 CFDA "on the release of medical device product technical requirements for the preparation of the guiding principles of the circular (No. 9)" has been from the product technical requirements for the preparation of the basic requirements of the guiding principles of the three aspects of the requirements, content requirements, format requirements. You can refer to CFDA's "Guidelines for the Preparation of Technical Requirements for Medical Device Products (Full Text)".
Subsequently, on September 5, 2014, CFDA announced the "Announcement on the Requirements for the Registration of Medical Devices and the Format of Approval Certification Documents (No. 43 of 2014)", which once again clarified the requirements for the declaration of medical device registration data and explanations, and Article 9 singled out the "technical requirements for the product".
Medical device product technical requirements and product standards comparison note
Product standards and product technical requirements are generally consistent, but there are some provisions such as packaging and transportation, product specification labels and other chapters alone, we would like to remind you in the process of compiling product technical requirements to pay attention to this change.