“Exclusive to China, the Hainan Boao Lecheng Medical Tourism Pilot Zone (the Pilot Zone) offers a unique Urgent Use Program, allowing international medical device manufacturers to trial China-not-yet-approved innovative devices on Chinese patients. Here, manufacturers can collect clinical evidence, generate sales revenues, showcase advancements, and benefit from Hainan’s commercial and regulatory advantages.”
Commercial & Regultory Benefits of the Hainan Pathway
Commerical Benefits | · Building relationships with Chinese medical institutions, practitioners, and stakeholders · Increaded brand visibility · Real-World feedback to improve device and training · Potential tax or economic incentives · Gateway to broader Chinese market |
Regulatory Benefits | · Accelerated market entry · Pre-Sub consultation · Real-world study · Clinical data on Chinese population |
Examples of Medical Aesthetic Products Landing to the Hainan Boao Lecheng Medical Tourism Pilot Zone via the Urgent Use Program
Medical Aesthetic Products | Intended Use | Hainan Local Hospitals/Clinics |
Micro-Focused Ultrasound Treatment Instrument | The principle of treatment is to focus ultrasound waves on a specific sub-epidermal soft tissue layer, forming unique thermal coagulation points precisely and clearly, thereby denaturing collagen and reshaping new collagen without damaging the skin surface. This improves facial aging, achieving skin tightening and anti-wrinkle effects. | Boao Super Hospital |
Lidocaine-Containing Cross-linked Hyaluronic Acid Sodium Gel for Injection | Suitable for medical aesthetic patients over 18 years old who wish to restore or create facial volume through treatment. Lidocaine helps reduce pain during treatment. | Boao Super Hospital |
MemoryGel Xtra Artificial Breast Implant | Applicable for breast augmentation and reconstruction. | Boao Yiling Life Care Center |
Legend Pro+ Radiofrequency Treatment Instrument | Used in medical institutions for reducing wrinkles. | Boao International Hospital |
PiQo4 Laser Treatment Instrument | Used for treating pigmentation. | Boao International Hospital |
HAIRCARE | The CYTOCARE series is used to reduce various visible impacts on the face related to age, lifestyle, or environment. It is injected into the superficial and middle dermis around the orbital and perioral lines (vertical lip lines). CYTOCARE516 improves the texture of moderately aged skin (filling fine lines, maintaining hydration and gloss). Patients may see slight improvements in fine lines within 7 days after 3 injection treatments, depending on their age and the initial state of the injection site. | Boao Yiling Life Care Center |
Injectable Facial Repair Material (CYTOCARE) | AestheFill is used for injecting into the dermal layer of wrinkles to fill and enhance volume, improving facial wrinkles. | Boao Yiling Life Care Center |
AestheFill Tissue Repair Material (AestheFill) | Sterile absorbable hyaluronic acid subcutaneous filler for tissue repair, used for deep dermal injection to treat morphological deformities of tissue lost due to accidents or diseases (such as asymmetrical treatments); widely used by beauty enthusiasts. | Ciming Boao International Hospital |
Deneb Sterile Absorbable Hyaluronic Acid Subcutaneous Filler | Used for injection and filling of epidermal and dermal tissues in the face (including the orbital area), neck, nape, back of the hands, and inner arms. | Hainan Qiyuan Stem Cell Anti-Aging Hospital |
Injectable Sodium Hyaluronate Composite Solution | Used for micro-injections in the superficial layers of the skin epidermis and dermis, improving skin condition and increasing tissue volume through the hydrating effects of sodium hyaluronate. | Hainan Qiyuan Stem Cell Anti-Aging Hospital |
Injectable Sodium Hyaluronate Solution | Used for injection and filling in the shallow layers of the dermis of the orbit, forehead, upper lip, and cheek skin. | Hainan Qiyuan Stem Cell Anti-Aging Hospital |
Injectable Cross-linked Sodium Hyaluronate Gel | Used for injection and filling in the skin epidermis and dermis, improving skin condition, correcting skin depressions, and increasing tissue volume. Lidocaine hydrochloride acts as a local anesthetic. | Huahan (Hainan) Cosmetic Hospital |
Lidocaine-Containing Cross-linked Sodium Hyaluronate Gel for Injection | This product is only used for deep dermal or subcutaneous layers, for increasing volume in depressed areas of the face and body, especially suitable for correcting skin depressions. | Huahan (Hainan) Cosmetic Hospital |
Poly-L-Lactic Acid Collagen Stimulator | The CYTOCARE series is used to reduce various visible impacts on the face related to age, lifestyle, or environment. It is injected into the superficial and middle dermis around the orbital and perioral lines (vertical lip lines). CYTOCARE516 improves the texture of moderately aged skin (filling fine lines, maintaining hydration and gloss). Patients may see slight improvements in fine lines within 7 days after 3 injection treatments, depending on their age and the initial state of the injection site. | Boao Yiling Life Care Center |