Registration Process for Medical Devices in Taiwan

C

Charlotte33

#1
Dear all,


Could anyone help me find the following information concerning the registration process for medical device in Taiwan:
  1. The list of documents required to register a medical device
  2. The cost of fees for registration
  3. The cost of renewal
  4. The average length of registration process
I am also looking for the same information regarding food supplements and drugs.

Thank you in advance to anyone who can help me!

Charlotte
 
Last edited by a moderator:
Elsmar Forum Sponsor
C

Charlotte33

#3
Thank you!

However, the registration fees and cost of renewal are not mentioned in these documents. Does anyone know where I can find this information?

And can anyone tell me how long the whole registration process usually takes?

Thank you in advance!

Charlotte
 
M

Mondo 22

#4
Hi Charlotte,

From my own experience registering medical devices in Taiwan, like other Asian markets can be lengthy.

In terms of cost and lead times this can vary, as im sure you are aware there are two phases to registering a device in Taiwan, 1 QSD and Product Registration.

I hope this helps.

Thanks,
Ray
 
C

Charlotte33

#5
Thank you Ray! Yes I am aware of the previous step concerning the QSD.

Given your experience, could you just give me an approximation of the time it generally takes you to complete the whole process (6 months? 12 months? More? Less?)

Concerning the fees, of course it varies, depending on the device nature and classification... But I am surprised that no rate list exists... Does this mean that we will know how much it costs only once we submit our application? Could you give me a broad range of fees that are usually applicable?

Thank you for your help.

Charlotte
 
M

Mondo 22

#6
A Class I medical device took roughly 6 months, and a Class II took 18 - 24 months.

In terms of cost, this is tough I would budget roughly ?5, 000 - 10, 000

I would suggest registering with a company like Emergo or Pacific Bridge Medical. (I am not affiliated with either)

Thanks,
Ray
 
B

Burgmeister

#7
Hi

Sorry to hijack a thread but I have been asked to look into Taiwanese registration so this thread seems to be the right one! I have been to the emergogroup website pointed out by Gert and it was pretty useful, however there wasn't any guidance on device classification. The Taiwanese government website only seems to have selected pages in English and when I attempt to follow any links on it I just get a page of Chinese characters.

Anybody able to help on device classification?

Thanks
 

sreenu927

Quite Involved in Discussions
#8
Hi..
Apologies for being silent for some time. I was busy with FDA inspection and just to share with all in the Cove forum that we had successfully completed the inspection with no 483:)

Ok coming back to this:
QSD: 2-6 months and is 20,000.00NT Dollar
QSD Amendment: NT$8,000.00 (provided no physical shift of mfg location;if it is so, then it will be a new QSD as above)
Classification fees: NT 1500.00 2-4 months
Class I registration: NT10,000.00 + license fees: NT 1500.00 processing time: 2 months
Class II registration: NT 10,000.00 - NT 30,000.00 + License fees: NT 1500.00
Class III registration: NT 10,000.00 - NT 50,000.00 + License fees: NT 1500.00
Variation in fees for Class II and Class III is for any new technology of the device or if there are no similar registered devices (like predicates in US).

Processing time for Class II & III: 2-14 months depends on how well your dossier is and how fast you respond to input request!

Hi Burgmeister - There is no classification guidance from Taiwan FDA. However, you can refer to the attached docs(these are available from Taiwan FDA website) for more information and understanding.

Let me know your product with intended use/brief description. I'l try to help you in classifying. As a mfg, if we classify, we will get an idea of the required documents and then need to send to Taiwan FDA for classification final decision.

Regards,
Sreenu
 

Attachments

Last edited:
B

Burgmeister

#9
Thanks Sreenu, I had seen those documents but they didn't really help much. I have pretty much concluded that our device is Class II. It is category 888.4580 according to CFR 21.
 
Thread starter Similar threads Forum Replies Date
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
M Medical Devices Registration Process on the Portugal INFARMED Databank EU Medical Device Regulations 3
T CFDA Simplifies Medical Device Re-Registration Process China Medical Device Regulations 1
M Informational Medical Device Registration Process in Brazil - Anvisa (Part 3) Other Medical Device Regulations World-Wide 133
S Cadastre Process and Brazil Medical Device Registration Differences Other Medical Device Regulations World-Wide 7
M Medical Device Registration Process in Brazil - Anvisa (Part 2) Other Medical Device Regulations World-Wide 71
C Medical Device Registration Process in Iraq Other Medical Device Regulations World-Wide 2
C Medical Device Registration Process in Taiwan Other Medical Device Regulations World-Wide 6
C Medical Device Registration Process in Iran Other Medical Device Regulations World-Wide 12
C Medical Device Registration Process in Oman Other Medical Device Regulations World-Wide 8
R Seeking Medical Device Registration Process in Korea Other Medical Device Regulations World-Wide 4
I Medical Device Registration Process in Italy - Class I and Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 2
R Class III Medical Device with CE Mark - UK Registration Process EU Medical Device Regulations 6
S Medical Device Registration Process in Russia Other Medical Device Related Standards 12
M Medical Device Registration Process in Brazil - Anvisa (Part 1) Other Medical Device Regulations World-Wide 301
J Class III Medical Device with CE Mark Approval - India Registration Process ISO 13485:2016 - Medical Device Quality Management Systems 10
R Identification of Russian Predicate Devices as part of the Registration Process Other Medical Device Regulations World-Wide 1
M What is the Brazil - ABIMED Registration Process Other Medical Device Regulations World-Wide 6
C How does the EPA Establishment Registration Process Work? Various Other Specifications, Standards, and related Requirements 2
Q PEAR (Process Effectiveness Assessment Report) Requirements for AS9100 Registration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M ISO 9001 Registration Process - Timeline for obtaining ISO 9001 certification Registrars and Notified Bodies 3
B IVD ANVISA Registration Process in Brazil and Registration Change Other Medical Device Regulations World-Wide 11
Q AS9100 Certification Process - It would automatically include ISO9001 Registration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Product Registration Process - Update from Emergo Other Medical Device Regulations World-Wide 0
Ajit Basrur Change in FDA Establishment Registration Fee process wef Oct 1, 2008 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
B CE Marking using the ISO13485 Registration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
G ISO 9001:2000 Registration, but no process approach and no measurable objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M 7.3.2.2 - Process Design in Remanufacturing - Registration Finding for no DFMEA Design and Development of Products and Processes 8
A Are Unions Helpful To and ISO 9001 or TS 16949 Registration Process Misc. Quality Assurance and Business Systems Related Topics 14
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
H Medical device Product Registration Registrars and Notified Bodies 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
B Health Canada - Blood Glucose Meter Registration Canada Medical Device Regulations 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
Q Is Establishment Registration Necessary? Other US Medical Device Regulations 1
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
JoCam Registration of other manufacturers devices UK Medical Device Regulations 3
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
M Establishment Registration US Food and Drug Administration (FDA) 3
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom