UKCA
certificate
Before 2024/6/30
After 2024/6/30
Follow MDD until 2022,12,08 for TSS
Follow MDR after 2022,12,08
UK PR :Obelis
MHRA registration
Class i
Class iia
Registration fee by Obelis
est. time Q3/2022 to get
UKCA certificate
UK PR: Obelis
MHRA registration
Registration fee by Obelis
Class iia
Follow UKCA validity
Class i
Follow MDD validity until 2022/12/08
Follow MDD validity
Follow MDD class is list
We put more p/N than it is in MDD
by this chance transition period
, illegal!!!!
Follow MDR after 2022/12/08
register again in MHRA with Obelis handling charge
On application process now.
Notify Body , DNV 有開信件證明我們目前正在申請ＭＤＲ中
handling charge per article numbers
Registration fee per registration
MHRA Class I registration again
Acknowledgeable before geting UKCA
Follow MHRA class iia list
Handling charge per article number
application fee per registration
Authorized by MHRA to do registration.
register again in MHRA with Obelis handling charge
DoC available anytime for the customer
客戶端
料號申請Class IIa
確認客戶需求料號是否已經在MHRA Class IIa 清單內。
已在清單內
不再清單內
酌收代辦費用
收取應該費用
MDD 關係
證書效期
TSS: 2022/12
NPWT: 2022/08
MDR 取代
產品面
標籤
UKCA Mark
廠商訊息
英代資料
實施時間：2023/7/1開始全面
Currently already registered
Class I
Class IIa
Not workable in EU after expiration
Model accepted by S2XXX
Only a few model name listed for registration #
Smuggle more part numbers for Class IIa in MHRA systems. Not a regular process with some risk.
MDR
TSS
NPWT
MDD EXP. 2022/AGU
MDD EXP. 2022/DEC
clinical evaluation plan and report,
co-sign by taiwanese doctor and james
new clinical study protocal
need to approved by independent EU Community first
The study protocol will be approved by Independent ethics committee (IEC) or institutional review board (IRB) prior to study start.
protocal is ready to be reviewd in July and Aug, 2022
after approval , It takes one or two years to complete the study after approved by the clinical experts.
The NPWT technical documentation assessment will be reviewed by DNV in early of July and it takes 2~3weeks.
European committee clinical experts will review the clinical investigation protocol.
Quality system on-site audit for one week in Sept
need to reply all NCR within two months.
get MDR Certificate
Medstrom register for Class II
Obelis start the process of registration on 6/23
Need about 61 days on process
click to edit
實施計畫展延到7/2024