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.
1. Medical devices for the treatment of diseases that are severely life-threatening and there is no effective treatment method:
• Fully consider the balance between the data expected to be collected after the medical device is marketed and the data collected before the market;
• Assess product risks and benefits comprehensively;
• Prove with the data collected before marketing that the medical device has shown efficacy and can reasonably predict or judge its clinical value;
• Conditional approval of the medical device is granted to be on the market.
2. Conditional approval of medical devices for marketing should help increase the chances of timely use of new devices for patients suffering from serious life-threatening diseases without effective treatments.
3. From the demonstration of conditional approval for marketing, the establishment of attached conditions, to the post-marketing data collection, conditional approval for marketing has flexibility in the requirements for clinical trials of medical devices, but it must not reduce the requirements of comprehensive evaluation in medical devices safety and effectiveness.
1. The applicant should fully evaluate the benefit risk ratio and residual risk of the conditional approval of the declared product for listing, and the risk assessment result should show that the benefit exceeds the risk;
2. In the process of filing product registration and after conditional approval for marketing, the applicant registrant shall continue to carry out clinical trials and complete other research work and requirements in accordance with the established clinical trial protocol;
3. In addition to the materials that meet the requirements of this guideline, the registration application materials should also meet other requirements for medical device registration applications.
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