Introduction

The China Food and Drug Administration (CFDA) recently proposed a draft circular to address the priority review designation issue for medical devices. The Circular Regarding Soliciting Comments Regarding Priority Review Designation Procedure for Medical Devices (CFDA Circular [2016] 40) – which was open for public comment until July 20 2016 – proposes the qualifying criteria, process and features of priority review.

Before being marketed in China, all Class II and Class III devices must follow a detailed technical review process conducted by the Centre for Device Evaluation (CMDE) under the CFDA or at the provincial level. The priority review designation discussed in the circular may offer the device applicant a shorter review timeline for the application.

Priority review

According to the circular, an applicant with a Class II device (limited to imported applications) or a Class III device (available for both domestic and imported applications) can request priority review when submitting the device application if the device has been enrolled in the National Science and Technology Major Project or the National Key Research and Development Plan, or if the device can:

  • diagnose or treat a rare disease and has outstanding advantages in clinical practice;
  • diagnose or treat malignant tumours and has outstanding advantages in clinical practice;
  • diagnose or treat a specific disease that frequently occurs in the elderly and there is no other effective way to diagnose or cure such disease;
  • diagnose or treat a specific disease that frequently occurs in children and there is no other effective way to diagnose or cure such disease; or
  • address an urgent clinical need and the same type of device has not yet been marketed in China.

The CMDE will assess whether a device is eligible for priority review and decide the priority review designation before the technical review process begins. For any application that has passed the initial eligibility review, a third party may submit an opposition to challenge the initial eligibility review result during the public notification period. A device application that does not receive priority review designation will follow the standard review process.

A device application that receives priority review designation will be eligible to take advantage of several features intended to expedite the review process. Notably, the device applicant can enjoy frequent interactions with the CMDE.

In some cases, the CFDA may exercise its discretion to determine whether a device application qualifies for priority review based on an expert panel's opinion, not just when priority review is requested by the applicant.

Comment

The CFDA has already developed two expedited approval processes for devices, including:

  • an accelerated approval for devices applicable to emergency public health incidents; and
  • fast-track approval for innovative devices.

Therefore, the release of the circular reflects the CFDA's determination to introduce new approaches to improve the device review time. Device companies are advised to monitor the changes recommended in the circular.

For further information on this topic please contact Katherine Wang at Ropes & Gray LLP by telephone (+86 21 6157 5200) or email (katherine.wang@ropesgray.com). The Ropes & Gray LLP website can be accessed at www.ropesgray.com.

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