The unapproved devices can be clinically used in Hainan to collect real world data (RWD) and support its regulatory approval from NMPA. Under the policy, the scale-up usage and clinical data collection plan for Juvéderm VOLUX, an Allegan manufactured injectable dermal filler, was launched in Hainan Boao Medical Pilot Zone on July 3, 2020.
What’s the Device?
Juvéderm is a leading brand of hyaluronic acid facial fillers. The fillers work by restoring lost volume in the face, filling lines and wrinkles and hydrating skin.
Juvéderm VOLUX is the latest addition to Allergan’s range of facial fillers. It is CE-marked medical approved to restore and create volume in the chin and jaw area.
VOLUX is the first sodium hyaluronate product in China to improve the volume of the chin and maxillofacial area. “It has significant therapeutic value for patients with mandibular retraction”, said Wang Danru, the deputy professor of cosmetic surgery department at Shanghai Ninth Hospital who is involved for the project.
Urgent Use Policy & RWD
The foreign-approved devices for urgent Chinese clinical needs, without predicates approved in China, can be imported to Hainan via the policy dated back to April 2018. And then Real-World Data (RWD) of the imported device can be collected to support the regulatory approval from national NMPA. For our latest review of Hainan RWD pilot program, please click HERE.
The Volux filler has enrolled around 120 patients for the RWD pilot.
Over the two years, over 100 medical devices and drugs have been imported to Hainan, including four represented by China Med Device, according to press release from Hainan government on June 9, 2020.
How to Obtain RWD?
On December 13, 2019, NMPA issued the “Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation (Draft).” The document specifies the sources of RWD as following:
- Data derived from electronic health records (EHRs)
- Medical claims and billing data
- Data from product and disease registries
- Patient-generated data, including from in-home-use settings
- Data gathered from other sources that can inform on health status, such as mobile devices.
- Data generated from the complete life cycle of the medical device: production, sales, transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.
Similar Devices on the Market
The U.S FDA classification of “Implant, Dermal, For Aesthetic Use” has the devices from the major manufacturers as below:
- Q-Med: Restylane injectable gels
- TEOXANE: RHA 2, RHA 3, RHA 4 dermal fillers
- MERZ: RADIESSE injectable implants
- SUNEVA MEDICAL: Bellafill dermal fillers
- PROLLENIUM: Revanesse Versa