Tags: | NMPA | Medical Device | Medical Device | 药监局 | 医疗器械 | 医疗器械 |

A. The Direction for the Application Form of Registration

1.      All the contents filled in shall be in both Chinese and English；

2.      Upon the application, the form shall be printed ；

3.      All the items must be completely filled in, and as for the vacant items, “/” shall be used to show inapplicability；

4.      The Name of Devices and Model, Name and Address of Manufacturer must be unanimously the same as the contents carried in the documents approved by the government of the Country (Region) of Origin, and must be consistent with the contents concerned carried in the test reports, operation manual of the product, and so on;

5.      Any enterprise shall not set up the format for the Application Form for Registration without authorization. The Application Form may be downloaded from the website:

       http://www.sda.gov.cn/ylqjzc/setup.exe

　

B. About the Application Documents

1.        The certificate of the legal production qualification of the Manufacturer.

1)        The certificate issued by the government agency of the Country (Region)of Origin to authorize the Manufacturer to engage in the production and distribution of medical devices（equivalent to the business certificate or manufacturing enterprise license）.

2)     The certificates may be submitted in the form of the copy thereof, subject to the seal by the original issuing agency or the notarization by the local notarization agency.

2.    The qualification certificate of the applicant

1)        Business certificate of the Applicant；

2)        The certificate of commission given by the Manufacturer to the agent for registration

3.    The certificate recognized or approved by the government of the Country (Region) of Origin to authorize the products as medical devices to enter into the market of the country.

1)        The certificate recognized or approved by the government of the Country (Region) of Origin to authorize the products as medical devices to enter into the market of the country.

(1)    In case of any special authorization documents specified by the government of Country (Region) of Origin for medical devices to be put into the market of the Country (Region) of Origin, such formal authorization documents as 510 K or PMA of the U.S. FDA, and the CE certificate of the EU shall be submitted.

(2)    In case of one of the following circumstances:

a. That no special authorization documents are required to handle by the government of the Country of Origin；

b. That in case of any change to the Products on the basis of the Products specified in the original special authorization documents, due to the difference in the partition of registration elements, no re-application is required by the government of the Country of Origin, the enterprise shall give a statement, and provide the following certificates:

①The free sale certificate issued by the government; or

②the certificate to the foreign government; and

③the enterprise self-guarantee declaration in conformance with the provisions concerned of local regulations

2)        In case of no document issued by the government of Country of Origin to authorize the medical devices to be put into market

(1)     If the products shall be regulated as medical devices in the Country of Origin, but they have not been authorized by the government of Country of Origin to be put into market, the Standards of the Products to be Registered authorized by the competent department shall be submitted; in case of Products of Class II or Class III, the full-performance test report, Clinical Trial Reports, risk analysis reports within the territory of China and other documents necessary for the registration of import products shall be submitted, subject to which, the application may be accepted and after the acceptance, the on-site inspection of the production quality system will be arranged.

(2)     If the products shall be regulated as medical devices in the Country of Origin，but need not be authorized by the government of Country of Origin to put in the market because they are produced specifically for China , the first paragraph of this Article shall be applied.

(3)      If the products fail to be regulated as medical devices in the Country of Origin but the Products are defined as medical devices in China in accordance with the definition of medical devices, the first paragraph of this Article shall be applied.

3)        the certificates may be submitted in the form of the copy thereof, subject to the seal by the original issuing agency or the notarization by the local notarization agency.

4.    The Standards of the Products to be Registered shall apply the Provisions for the Management of the Medical Devices Standards

1)        The methods for the implementation of “Only the Original of the Standards Sealed or Signed by the Legal Representative may be submitted”:

            (1) Standards of the Products to be Registered may be sealed through the following 

                  three methods:

            a.  to be sealed by the Manufacturer;

            b.  to be sealed by the office or representative office of the Manufacturer  in China；

            c.  to be sealed by the unit in charge of the conclusion, arrangement, drafting of the 

                Standards of the Products to be Registered commissioned by the Manufacturer.

                And in the certificate of commission, it shall be clearly indicated that “the ×××

                Unit is commissioned to be responsible for the completion of the Standards of the

                Products to be Registered in China, and the Manufacturer shall be responsible for 

                the quality of the Products” .

(         (2) the Definition of the Legal Representative：in accordance with the international 

               practices, " the signature and seal of the Legal Representative” of the

               Manufacturer abroad may be signed and sealed by the  senior official in charge of

               the corresponding business activities.

2)        The Standards of the Products to be Registered reviewed, codified, and recorded by SDA Standard and Technical Committee；

3)        As for the Products with national standard and industrial standards, the manufacturer shall, with the implementation of the standards mentioned above, based on its own specialties, supplement and add corresponding requirements, formulate the Standards of the Products to be Registered，and assure the safety and effectiveness of the operation of the Products； if the enterprise thinks that no requirements on safety need to be added, and that the direct adoption of national standard and industrial standards as the manufacturer Standards of the Products to be Registered is sufficient for the assurance of the safety and effectiveness of the products, the manufacturer shall submit a statement justifying that without any increase and improvement in the standard index on the basis of national standard and industrial standards, the safety and effectiveness of the products for application can be assured, declaring to bear the quality liabilities after the launching of the products and carrying the model, specification of the Products. As for the products with ISO or IEC standards, the manufacturer shall convert the standards to the Standards for the Products to be Registered.

5. Operation Manual of the Products

1)        The methods for the implementation of “Only the Original of the Operation Manual Sealed or Signed by the Legal Representative may be submitted”:

(1)     The Operation Manual of the Products of Class II or Class III shall be sealed by the Manufacturer；the Operation manual of the Products of Class I shall not be sealed.

(2)     The Definition of the Legal Representative：in accordance with the international practices, " the signature and seal of the Legal Representative” of the Manufacturer abroad may be signed and sealed by the person in charge of the corresponding business activities.

2)        Implementation of the “Administrative Provisions on the Operation Manual of Medical Devices” .
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:

（1）        Name of Product, Name, Address, Postal Code and Tel. of the Manufacturer；

（2）        Registration number of the products;

（3）        Applied product standards；