Medical Device Registration Requirements in Kuwait

[bblbbblb]

Does anyone have any info or guidance documents on the requirements for registering medical devices in Kuwait. A distributor we've been in touch with says that all he needs is a letter of authorization from us.

 

[MIREGMGR]

Our understanding is that (as your distributor says) the distributor/importer controls imports and is responsible to "register" his operation and the devices he will import with Ministry of Health.
However, our further understanding is that for specific Ministry of Health tenders...much of the purchases of devices being paid for with government funding through the MOH...the MOH specifies that devices shall have legal marketability in either USA or EU or both.

 

[Jamie Ward]

Would anyone know the timeframe it takes to register a medical device in Kuwait and the validity period for products once registered? If anyone has any documentation or links on the MD registration process in Kuwait it would be most appreciated.

 

[shirley635]

Would anyone know the timeframe it takes to register a medical device in Kuwait and the validity period for products once registered? If anyone has any documentation or links on the MD registration process in Kuwait it would be most appreciated.

Hello, do you know if there is any regulations for medical device in Kuwait? if yes, what shall we do before we put the medical device into Kuwait market? thanks!

 

[Jamie Ward]

Hi Shirley, i cam accross this document while researching. Acceptance by the MOH usually takes 2-4 weeks after application. Hope info helps you!

 

[shirley635]

Hi Shirley, i cam accross this document while researching. Acceptance by the MOH usually takes 2-4 weeks after application. Hope info helps you!

Hi, Jamie, thank you for your reply, the information is very helpful, thanks!

 

[Reparex]

Hi,

does anyone know if new medical device registration requires also any fees. Do I have to pay for registering in Kuwait.

Thanks a lot

 

[Docholzi]

Hi
well I can confirm about 4-6 weeks time to rgeister the Medical Devices (MD), but here is an official document of the Kuwait Authorities, listing 9 topics to be fulfilled before registering your MDs our distributor says. Don't know anything about fees, yet !!
Ulrich

 

[rinaric15]

Although Kuwaithas made the progress in improving and harmonizing the system of registration of
medical use products, still the procedure is not transparent enough. FDA registration and CE marks are
not automatically recognized here. The product has to be registered locally (even if it has FDA and CE
registrations).

Registration and re-registration of medical use products in Kuwaitis performed by the State Service for
Medical Devices and Medical Use Products. Registration is based on evaluation of the product by expert
testing agencies. Once registered, a product is included in the State register of medical equipment and
medical use products.

Registration is valid for five years.

The price for registration of a medical use product comprises of a cost of technical, pre-clinical and clinical
examinations performed by expert organization plus a fee for the certificate. The cost (price) for
examinations is specified in the individual contract with the expert organization, and can vary from a
couple of hundred USD to a couple of thousand – depending on the price of the contract with an expert
organization. Ukrainian distributors prefer that the US company pay for registration, in fact sometimes
they share costs. It is a subject of negotiations.

The following documents are required for the registration of medical use products:

Name/Address of the product manufacturer.
Power of Attorney.
Legal Status of the Commercial registration of the manufacturing facilities. Notarized.
Certificate/letter with the explanation of product’s origin.
Manufacturer Declaration of quality confirmation stating that the product complies with Medical Device
Directive 93/42EEC of 14 June 1993 or any other applicable directive/guidelines, on the company’s
letterhead. Original or notarized copy.
Certificates that applicable to your country: FDA (mandatory for the US), Free Sales, ISO 9001, 13485 :
2003 (mandatory for all countries). Notarized.
Conformity Declaration (Letter of Assurance) stating that the applicant complies with Medical Device
Directive 93/42EEC of 14 June 1993 or any other applicable directive guidelines performed by the
relevant Authorities.
Clarification of Catalogue Numbers of device as laid down in Annex IX of Medical Device Directive
93/42EEC of 14 June 1993. On the company’s letterhead.
Certificate of analysis/conformity/quality. On the company’s letterhead, stamped and signed by QA
Manager.
Patient leaflet/Instruction for use.
Product(s) specification/Specification sheet.
Pre-clinical and clinical data.
Technical data/dossier (if available).
The results of microbiological tests and toxicology information (if applicable).
Sterility and validation data (for sterile forms).
Samples.
Mock-ups/ images of product secondary & primary package (preferably as in printed view and in jpg
format).
Brochures, catalogues.

 

[StijnW]

I was wondering if anyone can provide me information on whom to contact to start a registration procedure. Or does the importer have to contact the ministry of health to obtain the needed information?