The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. Among them, 16 devices are applied in cosmetic surgery.
From April 1, 2024, these cosmetic devices shall not be produced, imported, or sold without obtaining a medical device registration certificate:
- Radio frequency skin treatment device
- Artificial bone
- Bone Repair Material
- Hydroxyapatite Bioceramics
- Calcium Phosphate Bioceramics
- β-Tricalcium Phosphate Artificial Bone
- Calcium sulfate artificial bone
- Collagen-based bone repair material
- Calcium phosphate bone cement
- Bioglass Bone Filler
- Sodium Hyaluronate Solution for Injection
- Facial implant
- Face lift
- Facial cone lifter
- Osteo inductive calcium phosphate bioceramics
- Chitosan solution for joint cavity
The Cosmetic Medical Device NMPA document also specifies that:
- The relevant registrants shall fulfill the responsibility of product quality, comprehensively strengthen the quality management of the whole product life cycle and ensure the safety and effectiveness of the listed products.
- From March 30, 2022, overseas registrants shall submit the following to the provincial NMPA where the legal representative is located:
- Medical Device Registration Plan
- Applicable safety standard commitment
- production quality management system and operation
- customer complaint handling and adverse event system
- Provincial NMPA should establish enterprise credit files, strengthen inspections of registrants and manufacturers, speed up the completion of product registration, and improve the quality management system
- The registrants shall apply the medical device certificate according to “Administrative Measures for Medical Device Registration and Filing” effective since October 1, 2021. Read our comprehensive review on the Measures.
- For medical devices that have been accepted but have not yet completed registration approval (including initial registration and renewal registration), the NMPA will continue to review and approve according to the original acceptance category. If registration is approved, a medical device registration certificate will be issued, and it will be shown in the remarks column of the registration certificate indicating the adjusted product management category.
- For registered medical devices, if the management category is adjusted from the third category to the second category, the medical device registration certificate will continue to be valid within the validity period. If renewal is required, the registrant shall apply to the NMPA for renewal of registration according to the changed category 6 months before the expiration of the medical device registration certificate.
Juvederm Volbella, indicated for lip enhancement, was approved by the NMPA on April 25, 2021. The clinical evaluation, conducted in Hainan utilizing Real-World Data methods, only enrolled 176 patients. Look at the list of devices approved through real-world data pathway.
For “Measures for the Supervision and Administration of Cosmetics Production and Operation” which came into effect since January 1, 2022. This is China’s first departmental regulation for production licensing, production management, operation management, and legal responsibilities of cosmetics.