Phases and Time of Medical Devices SFDA Registration

The whole registration process of a MD product contains four phases:
1) To prepare the technical materials and draft product technical standard;
2) To conduct clinical trial or verification;
3) To conduct type test;
4) To inspect, technical evaluate the completely set materials for product registration and then approve the application.

The reference time of them is:
1) Phase 1: Preparation of technical materials as well as standard written is entirely operated by the applicant of product registration (such as domestic and foreign manufacturers) and its authorized registration agent. Therefore, the cycle length depends entirely on the exchange and communication between the two sides.
2) Phase 2: The time of clinical trials with high techniques and complex operations depends more entirely on the applicants of product registration. Based on experience, it normally takes at lest 3 calendar months for domestic products and no less than 6 calendar months for foreign products.
3) Phase 3: The type test for product registration is conducted by MD testing institutions accredited by SFDA. About the time, it is not clearly defined. However, it usually takes at least 3 calendar months based on experience.
4) Phase 4: Chinese regulatory authorities spend within 30 working days for Class I, 60 working days for Class II and 90 working days for Class III respectively, in deciding if the product can be registered in China. For foreign products, it is 90 working days generally. Moreover, in the course of review of registration applications, the time for testing, expert review and hearing does not count within the period specified above. However, the corresponding authority for technical evaluation spends no more than 45 working days for review after receiving the itegrate supplemented materials required.

Therefore, based on product classification, domestic or foreign, IVD reagent or not, placing into market or not, the whole cycle is different absolutely. A good example is the more advanced new products. Once the risk and effectiveness of this product is difficult to determine, the technical evaluation authority authorized by SFDA can organize experts to review and hearings. The corresponding time does not count within the time limit. Thus, it is impossible to clarify the specific cycle length.