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:
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;