The DeneB hyaluronic acid, manufactured by South Korea’s BioPlus, completed the first injection in Hainan Lecheng Hospital on November 29, bringing advanced medical beauty solutions to domestic beauty lovers.
What’s the Product – Hyaluronic Acid Hainan
DeneB hyaluronic acid is intended for congenital, traumatic, pathological breast or buttock hypoplasia and asymmetry, fatty tissue loss and atrophy. With patented technology by complete crosslinking and multi-stage purification, it has advantages of longer lasting time, better contouring, and lower fluidity, achieving high viscoelasticity and durability.
It is an absorbable material which can be naturally decomposed in the body and the shaping effect can be maintained for up to 5 years. Also, the surgery is minimally invasive.
Hainan RWD Pathway
The product was approved in United States, Canada, Japan, Australia, Brazil, etc, but not yet in China. Hainan Real World Data program provided a shortcut for BioPlus products to be launched in China.
Hainan Boao special zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status, to be used in China. In addition to the overseas medical products being sold and commercialized faster through this special program, overseas manufacturers can apply for RWS to collect RWD as China local clinical evidence to support its national registration approval.
After the clinical urgency status is granted, Hainan NMPA will organize the first meeting within 10 working days.
Big names are on the trial list. It only took four months for Boston Scientific, from submitting the registration application to guaranteeing approval, for its Rezūm water vapor therapy equipment. Allergan, J&J, Edwards Lifesciences, Roche Diagnostics, Advanced Bionics, and Zimmer, also used the same pathway to get national approvals.
How to Obtain RWD
Hainan Boao is the first area in China where RWD can be widely used. NMPA issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” on November 26, 2020. It specifies six ways to acquire RWD:
- 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.
The First Trial
The first operation was led by Professor Mu Yan, a breast surgery expert, with multidisciplinary experts from medical cosmetology, plastic surgery, breast surgery and radiology in Beijing, Shanghai, Guangzhou and Hainan. The medical team went through three rounds of preoperative discussions.
The first patient was comprehensively analyzed, and a surgical plan was formulated to ensure safety and performance.
As the domestic demand for medical beauty becomes diversified, the Hainan RWD pathway provides patients with more choices. “We can enjoy international high-end medical aesthetic technology and services without flying abroad. I’m very happy to be a beneficiary of the ‘first mover’ policy”, the patient said.
View the recorded webinar on “Fast-Track Your Initial Clinical Use with the Hainan RWD/S Pilot Program”
Take a look at our service page on the Hainan RWD program