Opinions On The Review Of Clinical Registration Of “Facial Injectable Filler”
2024-01-17
On December 11, 2023, China NMPA’s Medical Device Technical Review Center publicly solicited opinions on four guidelines for the registration review of medical devices. These include clinical trial registration review guidelines for intracranial clot retrieval stent, extracorporeal membrane oxygenation system, spring coil system of the same variety, and facial injection filling material.
Key Points:
1. Facial Injection Product Scope:
Correction of nasolabial folds, improvement of nasal volume and shape, correction of mid-facial volume or contour defects, correction of lip asymmetry or contour deformities, and improvement of mild to moderate retrognathia using hyaluronic acid gel (including chemically cross-linked, excluding composite solutions).
Various products for correcting wrinkles, including animal-derived collagen and recombinant Type III human collagen.
Use of collagen and polymethyl methacrylate subcutaneous implant systems for improving nasal volume and shape
Poly-L-lactic acid facial fillers for correcting deep-layer wrinkles and poly-caprolactone facial fillers for subcutaneous tissue correction.
Infections (including internal activation of pathogens and external pathogen invasion).
Other reactions like the Tyndall effect, nodules, cord-like elevations, granuloma reaction, and vascular embolism.
3. Primary Clinical Evaluation Indicators:
Duration of effectiveness for various injection types based on the intended use.
4. Secondary Clinical Evaluation Indicators:
Additional assessments for certain products, including wrinkle severity at different time points, contour filling effects, and measurements of nasal volume changes.
5. Product Manual Development:
Inclusion of comprehensive information on possible complications and side effects in the manual.
Addressing complications such as lumps, itching, pain, redness, swelling, infection, scarring, skin erosion, necrosis, discoloration, implant displacement, nodules, granulomas, needle hole formation, asymmetry, unexpected correction results, allergies, and Tyndall effect.
Highlighting severe complications like blood circulation disorders, facial nerve damage, fainting, vision impairment (including blindness), and potential fatalities due to improper injection.
This information is crucial for medical professionals and consumers to ensure safe and effective use of facial injection products, as outlined by the NMPA.
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