1) The Standards of the Products to be Registered shall apply the Provisions for the Management of the Medical Devices Standards

 2) The Standards of the Products to be Registered reviewed, codified, and recorded by SDA Standard and Technical Committee；

 3) As for the Products with national standard and industrial standards, the manufacturer shall, with the implementation of the standards mentioned above, based on its own specialties, supplement and add corresponding requirements, formulate the Standards of the Products to be Registered，and assure the safety and effectiveness of the operation of the Products； if the enterprise thinks that no requirements on safety need to be added, and that the direct adoption of national standard and industrial standards as the manufacturer Standards of the Products to be Registered is sufficient for the assurance of the safety and effectiveness of the products, the manufacturer shall submit a statement justifying that without any increase and improvement in the standard index on the basis of national standard and industrial standards, the safety and effectiveness of the products for application can be assured, declaring to bear the quality liabilities after the launching of the products and carrying the model, specification of the Products. As for the products with ISO or IEC standards, the manufacturer shall convert the standards to the Standards for the Products to be Registered.