| |
|
|
|
 |
China represents an increasing
opportunity for sales of high-technology medical devices and diagnostic
reagents. |
|
| |
|
|
China is the largest and fastest
growing MD and IVD market in Asia |
| |
| £££¡¡Population of 1.5
billion |
| |
| £££¡¡2003, IVD generated
revenues of $700 million |
| |
| £££¡¡Annual
growth rate in the industry of more than 20% |
| |
If you are a medical
device or IVD manufacturer located outside China, and wish to export
into the Chinese market, you must follow several steps to ensure that
your product is in compliance with the Local Requirements. |
| |
| |
All imported medical
devices must be registered at the State Food and Drug Administration
(SFDA) of China. The SFDA has developed a comprehensive system for
product certification and inspection to ensure the safety, efficacy
and quality of all medical devices and in vitro diagnostics, which
are imported to China. |
| |
| |
SFDA
Registration Procedures: |
| |
|
|
|
|
| |
Applications for registration with
SFDA must submit the following materials: |
| |
|
|
| |
|
Qualification certificate of the medical device
(MD) or IVD producer;
|
| |
|
Qualification certificate of the applicant;
|
| |
|
Certificate the country of origin that permitted IVD product
to enter the market of that country;
|
| |
|
Technical specifications and corresponding testing reports;
|
| |
|
Clinical trial reports from more than two trial sites.
|
| |
|
The trials shall be conducted in compliance with the Provisions
on Clinical Trials for IVD Products;
|
| |
|
A statement of guarantee on quality of the product issued
by the producer, who must make a commitment in such a statement
that the product to be registered and sold in China will have
the same quality as the same product sold in the country of
origin;
|
| |
|
A letter of authorization which designates after-sales service
agencies in China, a letter of commitment and the business license
of such entrusted agencies;
|
| |
|
A statement of guarantee on the authenticity of the materials
submitted.
|
| |
|
Instructions for use; |
| |
|
|
| |
The above-mentioned documents must
have a Chinese language version. |
| |
|
|
| |
Companies have found it difficult
to conduct registration from overseas due to several reasons
including but not limited to:
|
|
| |
|
|
|
| |
Communication problems
Designation of a local after-sales service
GProviding samples to the testing centers
Certificates and licenses are issued to the manufacturers not to the
agent or distributor. Therefore, companies must arrange for the agent/distributor
to hand over the certificates or licenses.
SFDA requires that the registration coordinator must have adequate
technical knowledge regarding the product in order to ensure the effective
and efficient communication. |
| |
|
| |
It is therefore recommended
that the international companies should authorize a locally based
representative or distributor to handle the registration or other
necessary approvals. |
| |
|
| |
Wantai:
Your Regulatory Assistant in China |
| |
|
| |
Through the years of
operating, we have established very good relations with SFDA and other
institutions involved in the registration process in China. Wantai
Regulatory Department provides integrated registration and post-registration
services to international companies. Our Regulatory Department staff
has sufficient experience in regulatory affairs coupled with medical
devices and IVD practical knowledge and foreign languages skills.
We are able to assure the effective and efficient communication with
the SFDA through the registration process, and we are committed to
offer the most cost-effective and time saving strategies for registration.
|
| |
|
| |
What
we can offer you: |
| |
|
| |
SFDA Medical Devices
or In vitro Diagnostic registration application
|
| |
Submission of documents
|
| |
Translation of technical
documents
|
| |
Instructions for use
and label development
|
| |
After sales services
|
| |
Coordinating the registration
and approvals with the SFDA staff
|
| |
Updates on SFDA requirements
and identifying new strategies
|
| |
SFDA troubleshooting
|
| |
SFDA consultations |
| |
|
| |
Download
the SFDA Medical Devices Registration Requirements  |
| |
|
| |
Visit
SFDA web page at£º |
| |
|
| |
 |
| |
|
| |
|
