1 If the foreign manufacturer designates Kingson to register its medical device in SFDA of China , who is the holder of medical device certificate issued by SFDA of China?
SFDA only issues the medical device
certificate to the foreign manufacturer, the holder of medical device
certificate of SFDA of China can only be the foreign manufacturer, Kingson is
only the registration agent of foreign manufacturer in application, even
foreign manufacturer designates its distributor of China to do this
registration, the holder of medical device certificate of SFDA of China is
also the foreign manufacturer. Once Kingson gets the medical device
certificate from SFDA, Kingson will send this Certificate to the foreign
manufacturer by Fedex, the distributor of foreign manufacturer in China can
get the copy of this certificate from the foreign manufacturer and use this
copy all over China.
2
Can Kingson give manufacturer the registration budget and timetable of
particular medical device?
Yes
, of course. Please e-mail the names and models of medical devices to Kingson,
Kingson will visit the website of manufacturer for the details of the
particular medical devices and give the registration budget and timetable in
24 hours.
3
How much is Kingson medical device registration agency service if the medical
device has many models?
The
cost of Kingson medical device registration agency service is 15,000 RMB for
one kind of medical device; for example, the patient monitor has more that 3
models, every model has different configuration, although SFDA of China issued
3 certificates to 3 models of patient monitor, the cost of Kingson medical
device registration agency service is still 15,000 RMB.
4
What documents will needed in the registration of medical device in SFDA of
China?
Kingson is sorry not to answer this question, it is the scope of
Kingson medical device registration agency service; Kingson will give the list
of documents and document samples needed in registration to the manufacturer
after the manufacturer designates Kingson to provide the registration agency
service.
5
Can Kingson guarantees the manufacturer get the certificate for assurance?
Kingson
will do the registration agency service with due diligence, but Kingson can
not guarantee the manufacturer get the certificate for assurance. If the
manufacturer has got the CE certificate or FDA certificate for the medical
device and markets the medical device in Europe or U.S.A., the manufacturer
can also get the certificate from SFDA of China, it is just the question of
more time and additional cost in registration for the medical device marketing
in the People’s Republic of China.
6
How can the manufacturer trust Kingson when the manufacturer has no contact
with Kingson before?
Due
diligence is the main principal of attorney in agency service all over the
world, it is also the principal in Kingson registration agency service;
Kingson gives the manufacturer the registration report every month, if the
manufacturer has the doubt about the due diligence of Kingson, it is the duty
of Kingson to prove Kingson has provided the registration agency service with
due diligence.
7
What is the procedures of the manufacturer’s designating to Kingson?
At
first, Kingson gives the budget and timetable of particular medical device
registration in SFDA of China;
Secondly,
if the manufacturer agrees this budget and timetable, the manufacturer give
the fund to Kingson through bank;
At
last, Kingson begins the medical device agency service for the manufacturer.
8
What is the procedures of Kingson’s registration agency service?
At
first, Kingson gives the list of documents and document samples needed in
registration to manufacturer;
Secondly,
after Kingson gets the technical documents, Kingson designates the statutory
medical device testing institutions of China to draw technical specification
of this medical device, it costs 30 working days;
Thirdly, Kingson applies for the approval of the technical
specification from SFDA, it costs 40 working days;
Then, Kingson designates the statutory medical device testing
institutions of China to test the medical device, it costs 45 working days;
At last, Kingson applies for the certificate from SFDA of China when
the test report is issued by the statutory medical device testing institutions
of China, it costs 90 working days;
When the certificate is issued by SFDA of China, Kingson sends it through Fedex to the manufacturer, the manufacturer can give the copy of this certificate to its distributor of China.
9
Can the manufacturer get the certificate in shorter time limit?
The
above time limit is all assigned by the regulation of medical device of the
People ‘s Republic of China, this is the shortest time limit . No one can
break this time limit ( Class II and Class III ).
If
the medical device is classified in Class I in China, the time limit is
shorted than the above.