5. Registration Processes

Medical Devices - Class A
Kuwait

This section provides information on any product notification or registration and manufacturing site registration processes (MD Class A Route to Market).

6.1 General Requirements

Prior to product Registration in Kuwait, the manufacturer must:

• Establish a QMS ISO 13485 or US Good Manufacturing Practice (GMP) with a Design Control Process adapted to its product. 
• Develop its Products according to its QMS and build a Design History File, and Regulatory Dossier including Safety, Clinical, and Performance Evidence. 

If the Manufacturer does not have one of the two elements listed above, the registration could be challenged for low-risk products and not possible for high-risk products.

All devices should carry clear labeling, which should be identical to the approved country of origin labeling, and include:

1. Product name
2. Intended use
3. Manufacturing date and/or expiration date
4. Batch number
5. Legal manufacturer's name printed on the outer label
6. Country of origin printed on the outer box
7. English and Arabic versions for devices used by laypersons

6.2 Local Representative

• The next step is to appoint a local importer/distributor to serve as the in-country representative. 
• The representative will be considered as the owner of the registration, and responsible for the registration submission to the MoH.

6.3 Submission Process

Class A products would require formal submission to MoH at the following contact.

Ministry of Health, Drug and Food Control

Pharmaceutical and Herbal Medicines Control and Registration Administration

Sulaibkhat Jamal Abdel Nasser Street, PO Box 5, 13001, Kuwait

Tel: +965 24878168, 24878422, 24877952, 24877219

Fax: +965 24863714

Email: health@moh.gov.kw

The following parts of documents are required – in our case Class A column is applicable.

• Time to Market estimation: six to eight weeks, without taking into consideration the response times to questions. 
• The fees relating to medical device registrations are as follows (in Kuwaiti dinar, KWD): 
  1. company registration = KWD 250
  2. product registration = KWD 25
• Registration approval certificate validity: 5 Years.

6.4 Post Launch Obligations

• The manufacturer will have to establish a proper Post Market Surveillance Program ensuring proper reporting of customer complaints and complying with Kuwait Adverse Event Reporting system.
• Any major or minor changes in the product formulation (active or non-active), shelf-life, specification, storage conditions, labeling, manufacturing site, manufacturer, etc., should be reported to the Pharmaceutical and Herbal Medicines Control and Registration Administration.

6.5 References

1. MINISTERIAL DECREE FOR REGISTRATION AND RELEASE OF MEDICAL DEVICES M.D. ( 13 ) I 2022