Medical Device Registration Process in Oman

C

Caroline S

Dear all,

I am seeking medical device registration process in Oman.

Thanks in advance to anyone who can help me.

Caroline S.
 

Marc

Fully vaccinated are you?
Leader
One more quick "Bump" in case anyone here can help with this one. My Thanks in advance!
 
A

apollon

Is anybody able to actually open and read that document?
Importing it into Excel will only give me rubbish.

Also, guessing by the filename, it seems to be similar to the documents that can be found on the ministry's official website which describe necessary documents for "pre qualification for participation in the tenders of the ministry of health".
Will the requirements for importing and marketing medical devices automatically be the same as the ones for participating in tenders?

Thanks!
 
M

Marco L.

Can someone give an answer to this question? I've the same doubt. What is necessary for importing medical devices for the retail?
 
L

LFZR88

I can help a little, for the private sector there is no registration requirements, however for the public sector it is very different.
We usually take advice from our distributor but as a rough guide this is what we have previously sent for registrations -

ISO13485/CE/DoC These to be notarised and Apostilled
LOA
Site master plan file
Clinical data
Quality manual
Proof of registration in other countries
Technical summaries of the products to be registered
Statement of device constituent parts and materials (if applicable)
Manufacturing Floor plan

Hope that helps :bigwave:
 

Marc

Fully vaccinated are you?
Leader
Is anybody able to actually open and read that document?
Importing it into Excel will only give me rubbish. <snip>
Are you referring to "Extract of Pre-Qualification Requirement.xlsx" in the thread that is linked to in post 4 above? It opens OK for me.
 

newlaptop

Registered
I can help a little, for the private sector there is no registration requirements, however for the public sector it is very different.
We usually take advice from our distributor but as a rough guide this is what we have previously sent for registrations -

ISO13485/CE/DoC These to be notarised and Apostilled
LOA
Site master plan file
Clinical data
Quality manual
Proof of registration in other countries
Technical summaries of the products to be registered
Statement of device constituent parts and materials (if applicable)
Manufacturing Floor plan

Hope that helps :bigwave:
what about FSC?
 
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