Registration Procedures

State Food and Drug Administration:

Regulation of medical devices falls under the jurisdiction of the State Food and Drug Administration.  This government ministry is roughly equivalent to the U.S. Food and Drug Administration, and was previously known as the State Drug Administration.  All imported medical devices must get a registration certificate from SFDA before being sold in China.  The SFDA has a comprehensive system for medical device registration and inspection, which includes product type testing and factory audits. 

Who Submits the Registration Application

In contrast to many other Asian countries, China issues registration certificates and licenses in the name of the device manufacturer, not to the agent or distributor.  Therefore, companies should arrange for the agent/distributor to hand over the certificates or licenses.

What Medical Devices Need to be Registered

China’s Regulations for the Supervision and Administration of Medical Devices sets out three classifications for medical devices(Class I – III).  Medical devices in all three classes need to be registered.  Domestic manufactured products register with Provincial Health Bureaus, while imported medical devices must register with the State Food and Drug Adminstration.  Below are the general definations of each class. 

Class I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;

Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness

Class III Medical Devices are those which are 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.

What Risk Category is the Device?

SFDA has a document (Regulation for Medical Device Classification), which provides general guidance on how to determine which classification a device falls under.  (LINK TO CHINA CLASSIFICATION 2 DOCUMENT)

SFDA also has a classification catalogue for medical devices (in Chinese) which provides more information regarding which classification a device falls under.  This catalogue is organized in a manner similar to, but not the same as, the Global Medical Device Nomenclature System.  If a company is unable to determine their classification, they need to submit their product information to SFDA’s classification office (in Chinese).  The U.S. Department of Commerce’s Commercial Service staff in Beijing can help companies in getting this information to the proper SFDA official. 

How to Demonstrate Conformance with Chinese Standards

Chinese law requires each industrial product to have a Chinese national standard.  The Chinese national standard is usually the same as the relevant international standard, although sometimes with minor modifications.  Medical devices type testing must be based upon the Chinese national standard.  However, if there is no national standard, an industry standard, or a company-specified standard may be used.  Chinese testing laboratories work with companies to ensure that their company-specific standard are in-line with relevant national standards.

 What Information is Asked for During the Registration Process?

The following items are to be submitted with all applications:

• Business license
• This includes manufacturer's incorporation documents which contains registration number, company address, investor names, addresses, zip codes, etc., medical device manufacturing permit and other legal documents which can prove the legitimate qualification of the manufacturer.

• If an agent is processing the registration for the manufacturer, the application must include a letter of authorization stating that agent is the sole agent for the company’s registration and that the manufacturer is responsible for the product. 

• Manufacturing authorization document in the country of origin
• This includes documents showing proof of product marketing approval issued by the government of country (or region) of origin (such as 510K issued by FDA, PMA, or CE certificate issued by the European Union Notified Body).

• Product standard
• This includes the quality standards the product must meet before shipment from factory, such as a Declaration of compliance with adopted standards, either ISO, IEC or other standards technical requirements of the products.
• Product introduction: component, applications, materials, volume of product, sterilization method;
• Characteristics of the product: sterile, non‑thermogenic, etc.; disposable, self‑destroying model, reducing cross‑infection; factory standards

• Operation manual of the product
• The operation manual of medical devices shall implement the national standards provided in “Operation Manual for Industrial Products--General provisions”. In accordance with the specialty of the medical devices , the following contents shall be included:
• Name of Product, Name, Address, Postal Code and Tel. of the Manufacturer；
• Registration number of the products;
• Applied product standards;
• The main structure, performance, specification of the Products；the usage, scope of application, contraindication, precautions, cautions and suggestions of the Products;
• Interpretation of the figures, logos, abbreviations, etc. of the labels and marks;
• Illustration and graphic expression of the Installation and Operation;
• The Maintenance methods, special storage methods and length of life of the Products；

§         other necessary contents specified in the Product Standards.

• Type test report: issued by a medical devices quality test agency recognized by the State Food and Drug Administration within the recent one year (for Class II and Class III products). 
• Note that some high tech medical devices are eligible for registration before the results of testing are complete (Test-after-Registration) . 
• Certain laboratory equipment is also exempt from type – testing requirements .   

• Quality guarantee letter: stating the product is of the same quality as those sold in the U.S.
• After-sales authorization letter by the manufacturer: This agent is responsible for sales and after sale service, and must be located inside China.  Two letters have to be submitted: a letter from the manufacturer and a letter of promise from the agent.  The agent's name will appear on the 2nd page (attached to the registration certificate).  If a manufacturer wants to change its designated agent, it must inform SFDA.
• Manufacturer or agent’s declaration that the data and information submitted in the registration document are accurate.

How Long Does It Take for an Application to be Processed?

The SFDA has 90 working days to complete its regulatory review of each product.  This three-month period however, is not binding as some questions will be asked and additional materials required.  U.S. companies report that the product registration time has increased from 4-6 months, up to a year.  License renewal applications (which must be done every 4 years) can also take between 4 – 6 months, as they are often treated the same as new product.  In addition to the 90 day review period, SFDA has a requirement that laboratories complete all testing within one month.  In theory, if a lab can not do the required testing within a month, SFDA will accept test reports conducted in the product's country of origin.  In practice, this often takes 60 – 90 working days.  This lab testing time period is not included in the SFDA 90 day review period.