The 3-stage timeframe for UDI system implementation was initiated on June 1st, 2021. Class 3 implantable medical devices are the first batch of products to adapt UDI. Afterward, Class 3 non-implantable medical devices have to integrate with the UDI system beginning on June 1st, 2022. Finally, until earlier this year, Class 2 medical devices shall comply with all UDI regulations and requirements starting from June 1st, 2023.
Holders of medical device licenses should upload the Device Identifier (DI) and other related medical device information onto the Taiwan UDID platform before importing or distributing the products.
Timeframe of UDI System Implementation:
|
Stage |
Enforcement Date |
Medical Devices |
|
Stage 1 |
June 1st, 2021 |
Class 3 implantable medical devices |
|
Stage 2 |
June 1st, 2022 |
Class 3 non-implantable medical devices |
|
Stage 3 |
June 1st, 2023 |
Class 2 medical devices |
The following kinds of medical devices are not required to integrate UDI:
|
1. |
Customized medical devices.
|
|
2. |
Medical devices specifically for export only.
|
|
3. |
Single-use and non-standalone or non-implantable medical device components that are sold with a medical device combination kit or in vitro diagnostic medical device. |
The following medical device classifications are not required to label PI (Production Identifier):
|
Item |
Classification No. |
Classification Name |
|
1 |
E.1120 |
Blood pressure cuff |
|
2 |
E.2770 |
Medical Impedance plethysmograph |
|
3 |
G.5220 |
Ear, nose, and throat drug administration device |
|
4 |
I.0004 |
Alcohol pad |
|
5 |
I.0005 |
Providone-Iodine pad |
|
6 |
I.4014 |
Nonresorbable gauze/sponge for external use |
|
7 |
I.4040 |
Medical apparel |
|
8 |
J.0001 |
Saline solution for wound irrigation |
|
9 |
J.2910 |
Clinical electronic thermometer |
|
10 |
J.5240 |
Medical adhesive tape and adhesive bandage |
|
11 |
J.5780 |
Medical support stocking |
|
12 |
L.5300 |
Condom |
|
13 |
L.5310 |
Condom with spermicidal lubricant |
|
14 |
L.5400 |
Menstrual cup |
|
15 |
L.5460 |
Scented or scented deodorized menstrual tampon |
|
16 |
L.5470 |
Unscented menstrual tampon |
|
17 |
M.5925 |
Soft (hydrophilic) contact lens |
|
18 |
M.5916 |
Rigid gas permeable contact lens |
|
19 |
M.5918 |
Rigid gas permeable contact lens care products |
|
20 |
M.5928 |
Soft (hydrophilic) contact lens care products |
|
21 |
O.3800 |
Motorized vehicle for medical purposes |
|
22 |
O.3860 |
Powered wheelchair |
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