Acts of the State Bureau of Food and Drug Supervision and Administration

< Methods of registration and administration for medical apparatus and instruments > was considered and passed though the bureau affairs conference of the State Bureau of Food and Drug Supervision and Administration on May 28th, 2004, now it is issued and goes into force from the date of issue.

Methods of registration and administration for medical apparatus and instruments

Chapter I General provisions

Article 1 This method was stipulated based on for the sick of standardization of the registration and administration of medical apparatus and instruments and insurance of safety and effectiveness of the medical apparatus and instruments.

Article 2 Medical apparatus and instruments to be sold and used within the borders of the People’s Republic of China shall apply for registration, according to the stipulations laid down in this method, those medical apparatus and instruments that are not obtained permission for registration are prohibited from being sold and used.

Article 3 Registration for medical apparatus and instruments refers to the process of evaluating the safety and effectiveness of the medical apparatus and instruments intended to be sold and used systematically in the light of the legal procedure, as to determine whether they can be sold and used.

Article 4 China institutes the medical apparatus and instruments according to the classification.

Medical apparatus and instruments of Class 1 within our borders shall be examined by the Food and Drug Supervision and Administration organ at the level of municipality, and issued the registration certificate of medical apparatus and instruments after approval.

Medical apparatus and instruments of Class 2 within our borders shall be examined by the Food and Drug Supervision and Administration organ at the level of province, autonomous region and municipality directly under the Center Government and then issued the registration certificate of medical apparatus and instruments.

Medical apparatus and instruments of Class 3 within our borders shall be examined by the State Bureau of Food and Drug Supervision and Administration and issued the registration certificate of medical apparatus and instruments after approval.

Medical apparatus and instruments abroad shall be examined by the State Bureau of Food and Drug Supervision and Administration and issued the registration certificate of medical apparatus and instruments after approval.

Registration for the medical apparatus and instruments from Taiwan, Hongkong and Macao shall refer to that for the medical apparatus and instruments abroad besides the specific stipulations of this method.

The term of validity of the registration certificate for the medical apparatus and instruments shall be 4 years.

Article 5 Registration certificate of the medical apparatus and instruments shall be centralized printed by the State Bureau of Food and Drug Supervision and Administration and the corresponding contents shall e filled in by the food and drug supervision and administration departments in charge of examination and approval for registration.

The registration number is arranged as follows:

x (x) 1(F) SFDA (x2) xxxx3x4xx5xxxx6, where:

x 1 Short form of the location of the registration and examination department:

For medical apparatus and instruments of Class 3 within our borders, medical apparatus and instruments abroad and those from Taiwan, Hongkong and Macao: it will be (C);

For medical apparatus and instruments of Class 2 within our borders: it will be the short form of the province, autonomous region or municipality directly under the Central Government where the departments for registration and examination are;

For medical apparatus and instruments of Class 1 within our borders: it will be the short form of the province, autonomous region or municipality directly under the Central Government where the departments for registration and examination are plus the short form of the administrative region at the municipality level in the community, i.e.x x 1 (It will be only the short form of the province, autonomous region or the municipality directly under the Central Government if there is no corresponding administrative region at the municipality level) ;

x 2 is the registration form (Approval, import and allowance)

“Approval” applies to medical apparatus and instruments within our borders;

“Import” applies to medical apparatus and instruments abroad;

“Allowance” applies to medical apparatus and instruments from Taiwan, Hongkong and Macao;

x x x x3 is the year for approval;

x 4 is the category of production administration;

x x 5 is the number of production variety;

x x x x 6 is the serial number of registration.

The registration certificate is accompanied with the (See Appendix 1 of this method), which will be used together with the registration certificate of medical apparatus and instruments.

Article 6 Where manufacturers apply for medical apparatus and instruments registration shall undertake the corresponding legal obligations and keep the registration certificate of medical apparatus and instruments after approval.

Whoever that conduct the application for registration of medical apparatus and instruments shall be entrusted by the manufacturers, and shall possess the corresponding professional knowledge, and be familiar with the laws, regulations, rules and technical requirements for registration of medical apparatus and instruments.

Manufacturers abroad, applying for registration of medical apparatus and instruments abroad shall appoint an organ to be its agent in China, that will undertake the corresponding legal obligations; Meanwhile, the manufacturers shall entrust a qualified legal organ in China or entrust its organ in China to undertake the after sale service for medical apparatus and instruments.

Article 7 There shall be applicable product standards for the medical apparatus and instruments applied for registration, either adopting the national standards or the trade standards, or stipulating the standards for the registered products, which, however, shall not be lower than the national standard or the trade standard.

The standard for registered products shall be stipulated in the light of the administration requirements for medical apparatus and instrument standards laid down by the State Bureau of Food and Drag Supervision and Administration.

Article 8 Manufacturers applying for registering medical apparatus and instrument of Class 2 and Class 3 shall meet the requirements for production conditions or for the related quality system laid down by the State Bureau of Food and Drag Supervision and Administration.