Required documents for Class III Medical Device in Yemen

S

Slayer_ch

Does anybody have a list of required documents to be able to register a Class III Medica Device in Yemen?

Thank you all for your help!!
 
T

temujin

Hi,

Unless you get a better answer from someone else, I would suggest you to contact the Yemenese (ehh...Yemenian(?)) health authorities or the national body regulating medical devices in Yemen and ask them.
A "Class III" device is basically a definition applied in EU and USA and although adopted my lots of others countries there might be differences.

good luck


regards
t.
 
M

MIREGMGR

Agreed.

Here is the Yemen medical device regulatory contact in the US, from the FDA website:

Minister, Economic and Commercial Department
Embassy of Republic of Yemen
2600 Virginia Avenue, N.W., Suite 705
Washington, D.C. 20037

If you're in another country and/or your native medical device regulatory environment is EU MDD (which is probably the case, if this post is correctly categorized), you may want to do a web search local to you.
 

Ajit Basrur

Leader
Admin
Or directly to -

Director-General
Supreme Board of Drugs and Medical Appliances (SBDMA)
Ministry of Public Health
P.O. Box 265
Sana'a
Telephone: 967 2 252 210
Fax: 967 2 251 632
 
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