China: Reduced Clinical Trial Requirements Ease Regulatory Burden
It has been reported by law firm Sidley Austin that a new rule has been issued by the Chinese State Food and Drug Administration (SFDA) which is designed to simplify clinical trial requirements for manufacturers of Class II medical devices. The rule is hoped to streamline regulatory review processes and timelines for eligible Class II medical devices.
21 types of Class II devices have been defined by SFDA to be eligible for a waiver of local registration trials. Prior to this ruling, a large number of medical devices required local clinical trial prior to obtaining SFDA approval. The 21 device types which have access to a waiver include:
- Basic surgical instruments
- Operative orthopaedic surgical instruments
- Injection and puncture instruments
- Devices for general examination
- Medical electrical devices
- Medical x-ray auxiliary parts and equipment
- Devices for clinical laboratory tests
- Materials for stomatology
- Medical health dressing
- Medical polymer materials and products
- Equipment for:
- Cardiopulmonary bypass and blood circulation
- Operation and emergency rooms
- Stomatology
- Ward rooms
- Medical cold therapy/low temperature storage
The ruling requires that the manufacturer lodging the marketing authorisation application must be able to provide a comparative illustration of their device with a device of the same type which has already holds SFDA approval. The illustration must include information regarding the function mechanism(s), product materials, structural composition, primary technical performance indicators, methods for sterilisation (if applicable), and expected use (including for home use or other).
Announced on the 24th November 2011, the Clinical Trial Waiver was said to be effective immediately. It is recommended that manufacturers consult with the SFDA where possible to ensure the comparative illustration suitably demonstrates consistent safety and efficacy profiles between the devices.
For assistance accessing China and/or other international medical device markets, contact KD&A or visit our services page.