The NMPA organized the formulation of and released the Guidelines for Conditional Approval for Marketing of Medical Devices on December 20, 2019. They recognized the urgent need for certain devices and IVDs. Those indicated for life-threatening illnesses can be granted Conditional Approval if the benefits of the product outweigh the risks. The manufacturer must also be committed to perform further clinical research. NMPA’s Guideline on Conditional Approval for Medical Devices, released on December 20, 2019, includes the following:       • Premarketing clinical data must be able to show preliminary efficacy or to reasonably predict clinical value;       • Surrogate endpoints can be allowed;       • The expiration date on the approval certificate must be identical to the completion date of the post-market study;       • The risks must be shown on the label and IFU;       • The standards of safety and efficacy must be unchanged with regular market approval. The Guideline also provides the contents of pre-clinical study and clinical study required before approval and the acceptable forms of post-market after Conditional Approval.