China's SFDA and Beijing Alan Business Solutions, Inc.      Until 1998, China's food regulation and safety management of food, pharmaceuticals and State Food & Drug Administration (SFDA) was governed by the Ministry of Health. In 1999, State Drug Administration (SFDA) became a separate bureau in 1999. This Agency's name was changed in 2003 to the State Food and Drug Administration (SFDA) and remained separate. In July 2007, irregularities within the organization was into question. In March 2008, the SFDA was restructured back into the Ministry of Health. The SFDA is responsible for developing policies and plans for the supervision of drugs, medical devices, cosmetics, and food safety in the consumer contact sector and supervising their implementation. It also participates in drafting relevant laws, regulations, and normative documents. The Agency conducts international exchanges and cooperation related to food and drug regulation, in addition to overseeing other work assigned by the State Council and the Ministry of Health. The SFDA requires that all cosmetics, medical device, IVD and pharmaceutical companies with no location in the People's Republic of China appoint a registered Legal Agent and After Sales Service Agent (in-country regulatory representative). Appointed SFDA Legal Agents and After Sales Agents must be residents of China or maintain a place of business in China. Beijing Alan Business Solutions, Inc. can serve you as a Legal Agent and/or After Sales Agent to protect your business interest, in addition to obtaining the import product registration/sanitary license. Over the past 13 years, as an industry leader, we helped nearly 1,000 companies and processed thousands of products achieving a 97% success rate. Product Registration: CosmeticsMarket overviewThe Chinese cosmetics market is fast growing, more than twice the average growth of the world market. In particular, the main product in the Chinese cosmetics market was foundation cosmetics. But recently the sales of color cosmetics and functional cosmetics are increasing. Most of the Chinese cosmetics market is occupied by U.S. cosmetics companies. As of 2008, of the top ten cosmetics companies in China, 7 were U.S. companies. 66% of cosmetics are sold in the department stores and supermarkets. But call sales is growing and the sales of functional cosmetics through pharmacy is growing too. Definition of cosmeticsThe sanitation supervisory ordinance for cosmetics defines cosmetics as following: Cosmetics means articles intended to be rubbed, poured or sprayed on the human body (skin, hair, nails, lips, etc.) or oral mucosa for cleansing, protection, beautifying or make-up. SFDA categorizes cosmetics using three criteria: 1. Form: cream, gel, lotion, etc. 2. Area of application: skin, hair, etc. 3. Effect: general cosmetics and cosmetics for special purpose. *General cosmetics: skin protection, hair control, make-up, fragrance, oral hygiene, etc. *Cosmetics for special purpose: prevention of hair loss, hair dyeing, hair removal, supple breast, figure management, odor removal, removal of blemish, sun protection. The criterion first considered during the conformity assessment when applying for the sanitation permit is the effect of cosmetics.For cosmetics containing new ingredients or for special purposes, safety evaluation tests and clinical studies must be conducted together.
Total duration for general-purpose cosmetics based on 5 working days. Industry Average: over 180 days vs. Beijing Alan: 115 to 150 days Notes: *No second application shall be filed for any product not approved for any reason involving safety of the product, such as containing any prohibited substance or any out-of-limit restricted substance, failure to pass through the hygiene and safety tests, etc. (Article 13, 25 Dec 2009) *Import product registration/sanitary license is valid for 4 years. We provide the renewal service at a minimal cost. *Due to the often-changing policies, this information is subject to change. Contact us for the most current information.
What kind of materials do I need to file for the general-purpose cosmetics?
Notes: *Due to the often-changing policies, this information is subject to change. Contact us for the most current information. *For the most part, we will either complete the forms ourselves or provide you with a template with an example. That was Easy! What kind of materials do I need to file for the special-purpose cosmetics?
Notes: *Due to the often-changing policies, this information is subject to change. Contact us for the most current information. *For the most part, we will either complete the forms ourselves or provide you with a template with an example. That was Easy! What kind of materials do I need to file for the a new cosmetic ingredient?
Notes: *Due to the often-changing policies, this information is subject to change. Contact us for the most current information. *For the most part, we will either complete the forms ourselves or provide you with a template with an example. That was Easy! What are the important factors in the import product registration/sanitary license process?The most important items during the process are the accuracy of ingredients, insert sheets and labeling and packaging cosmetics, a total of 494 ingredients indications. SFDA clearly specifies, in the sanitation quality standard for cosmetics announced by the Ministry of Health for the conformity assessment for the safety of cosmetics, the chemical and microbiological sanitation quality standards for cosmetics and the tests for banned chemical substances, color additives, preservatives and uv absorbers. Of the ingredients of are banned including biological products containing drugs and pesticides, hormone, hazardous ingredients of plants, mad cow disease-related raw materials, radioactive materials, etc. and they include 67 chemical substances, 42 preservatives,22 uv absorbers and 157 colorants. Notes: *Due to the often-changing policies, this information is subject to change. Contact us for the simplifed solution. That was Easy! Product Registration: Medical DevicesMarket overviewIn 2005, China became the 3rd largest medical device market following the U.S.A. and Japan. In 2006, trade value of Chinese medical devices exceeded 10 billion US dollars, and in 2008, even faced with the greatest global financial crisis in 100 years, the medical device industry was relatively stable and could respond to the risk backed by high return and steady capital investment. The trade value of Chinese medical devices is expected to exceed $20B by the year 2012.Throughout the international market, the comparison of medical device market and medicine market is 1:1, but it is 1:3 in China, which indicates that there’s further huge development for Chinese medical device. Chinese government has allocated sizable amount of budget in the medical health care of rural regions, particularly supply of medical devices and is concentrating on upgrading the medical devices used in rural regions suggests the Chinese medical device market will continue to expand. Considering these situations, it is necessary for domestic medical device companies to approach the Chinese market with mid- and long-term plans Definition of medical devicesArticle 3 of the People’s Republic of China State Council Order No. 276 defines a medical device as follows. “Medical devices” as defined by these regulations refers to any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means. Its intended objectives are 1. Diagnosis, prevention, monitoring, treatment or alleviation of disease; 2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions; 3. Investigation, replacement or modification for anatomy or a physiological process; 4. Control of conception. SFDA calls devices that conform with the above regulatory definition and intended objectives medical devices, and in accordance with the national order, regulations and enforcement decrees being enforced with the Regulation for the supervision and administration of medical devices, audits, evaluations and registration/control are conducted. Medical device classification•Class I: low risk, considered safety, general control safety and effectiveness can be ensured through routine administration •Class II: middle risk, relative safety, special control further control is required to ensure their safety and effectiveness •Class III: high risk, highly special control implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness 
Time Line•Class I: 5-6 months •Class II & III without clinical: 7-8 months –Marketed in country of origin –Manufacture is ISO 9000-certified –Product modification does not affect safety and efficiency –Non-implants, no radioactive sources –Would not cause serious injury or death to patient and operator •Class II & III with clinical: 12-14 months Notes: *Due to the often-changing policies, this information is subject to change. Contact us for the simplifed solution. That was Easy! Required Documents: Medical Device•SFDA registration form •Legal production qualification (FDA registration) •Business license of Chinese agent, who must be located in China, have a valid business license and a letter of commission from the manufacture •Marketing approval from government of country of origin •Product Standard •Operation Manual •Test report issued by SFDA-certified test center •Clinical trail report •Quality Guarantee letter •Letter of authorization to agent undertaking the registration •Post-sales authorization •Self-guarantee declaration Notes: *Due to the often-changing policies, this information is subject to change. Contact us for the simplifed solution. That was Easy! Product Registration: PharmaceuticalsDefinitionDrugs refer to articles which are used in the prevention, treatment and diagnosis of human diseases and intended for the regulation of the physiological functions of human beings, for which indications, usage and dosage are established, including Chinese crude drugs, prepared slices of Chinese crude drugs, traditional Chinese medicine preparations, chemical drugs substances and their preparations, antibiotics, biochemical drugs, radioactive pharmaceuticals, serum, vaccines, blood products and diagnostic agents. Excipients refer to the vehicles and additives used for drug production and prescription dispensing. Drug manufacturers refer to enterprises exclusively or partly engaged in drug production. Drug distributors refer to enterprises exclusively or partly engaged in drug distribution Product Registration: Dietary supplements, foods, water-related products, clinical research, trademard/patents
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