What are types of dermal fillers registered in China & How they perform

It was well known that dermal fillers used for plastic surgery gained a dramatic development in China during last two years, which is due to people’s greater attention on their health and beauty.
From this side, CIRS would like to share some industrial information with people who may concern, also based on one of our completed case experience of one imported Hyaluronic Acid (HA) filler.
Currently, dermal fillers those have been registered in China are classified into four types: which are collagen dermal filler, sodium hyaluronate acid (HA) dermal filler, non-absorb dermal filler and Botox dermal filler.

1. Collagen Dermal filler

a. The market situation analysis:
The raw materials of Collagen Dermal Filler are mainly from animal skin, generally is from pig skin or cow leather, and of which collagen is the main ingredient. Regarding that the collagen is one of compositions in human body, so such product has good biocompatibility, and can be easily absorbed by human body. It can stay a long time after filled into bodies, and can also stimulate the body to produce collagen. The health food contains collagen has been widely sold in China and is very popular among people.
Currently, the best dealer in China who sell Collagen Dermal Filler is Sunmax 台湾双美生物科技股份有限公司, and their most popular product is Sunmax Collagen Implant Ⅰ – Plus (商品名：双美I号-Plus), of which the raw material is purified from pig skin, and prefilled into the syringe. It is the first one that legally registered in mainland China, and are widely used in a large number of hospitals and beauty salons, but its price is a kind of expensive in China. There is a same domestic product named 肤美达, of which the raw material is purified from cow leather, and prefilled into the syringe. It is produced by Changchun Bertrand Pharmaceutical Biotechnology Co., Ltd, they obtained their first CFDA registration in 2012.04.13 and started to developing business stands for domestic Collagen Dermal Filler.
b. Requirements to register in China
Registration background analysis: currently, animal source medical devices in China belong to the high risk medical devices, and CFDA holds a strict attitude and approval to such products, not only to consider the safety of the animal source, but also shall consider its biocompatibility to human body. Therefore, as far as the manufacturer is concerned, they shall focus more on the basic research during R&D, and be careful of the choice of suppliers, and shall improve the animal protein purification process, conduct effectiveness validation, biocompatibility test, virus sterilization validation, etc. The manufacturer shall fully conduct the basic study of the product. During the product testing, varied protein types and immunogen shall be tested based on the intended purpose, and bio-test shall be done according to the requirements of ISO 10993.

2. Sodium Hyaluronate Dermal Filler

a. The market situation analysis
The sodium hyaluronic acid filler (HA filler) is the most mature product in China compared to other dermal fillers. In the beauty field, such product occupied a higher rate; also hyaluronic acid is one of compositions in human body, so such product has good biocompatibility. HA filler is widely used in the field of medicine and medical device as well; its safety and effectiveness have been widely acknowledged. In recent years, more and more foreign companies are planning to import HA filler into China market, at present several foreign companies have successfully open their market and accepted by hospitals and beauty salons. For present HA filler, their main source of raw materials is from comb purification or biological fermentation purification, it is cross linked and colorless. The HA filler market is exhibiting a dramatic increase and will have great market competition in the following decades.
b. Requirements to register in China
Registration background analysis: the HA filler approved by CFDA is more mature, and have comprehensive national standard & guideline for reference, their current classification is class Ⅲ implantable medical devices, and is under critical regulatory supervision of CFDA. Different raw materials source of sodium hyaluronate shall provide different dossiers when apply for CFDA registration, for example, the animal source HA filler requires for sufficient study of its raw materials suppliers, supplied goods, inactivated virus, immune prototype, protein purification process, etc; HA filler prepared from microorganism fermentation requires for sufficient study of its removal of microorganisms, heat remover, removal of hemolysin and protein purification process.

3. Non-absorb Dermal Filler

a. market situation analysis:
Currently, such products are mainly made of PMMA material or silicone material, and generally used as ophthalmology crystal raw materials or breast enhancement products. These products are gradually eliminated from hospitals and beauty salons in China due to their non-absorbed performance. The most sold products now are plastic collagen and PMMA subcutaneous implant system (trade name: Artecoll 爱贝芙), which are manufactured by Hafod Bioscience B.V. (Netherlands).
b. Requirements to register in China
This product is non-absorbed product, belongs to class Ⅲ implantable medical devices, it requires for the high biocompatibility and stability after implanted into the human body. The manufacturer shall conduct the full study of the safety and effectiveness of the raw materials, and the long term biocompatibility study after implantation.

4. Botox Dermal Filler

a. market analysis:
The botox beauty needle is also used in a lot of hospitals and beauty salons currently, it is mainly used for anti-wrinkle, thin face, slim leg, etc., this product is mainly composed of botox, and its main components is highly purified botox a-type, which is a kind of block agent of nerve conduction, it is used to treat overactive muscle. Currently, such products are managed as drug in China and there are no medical device approved by CFDA. Domestic institutions mainly use imported botox, which has potential risk to human body, so the usage shall be controlled during the clinical application.
b. Requirements to register in China
At present the product is mainly managed as drug in China, so its registration shall be handled in accordance with the provisions of the drug registration measures.