Saudi Arabia (KSA)

The Saudi Food & Drug Authority (SFDA) is the authority responsible for medical device vigilance and quality control. The Saudi medical device classification system may be based on either that of the EU, Australia, USA, Japan or Canada. The validity of your registration in the KSA follows the validity of the registration where your SFDA registration is based upon. About 10 years ago the SFDA issued a Medical Devices Interim Regulation (MDIR) and in addition launched an electronic system, the Medical Devices Marketing Authorization System (MDMA), to authorize medical devices after they comply with the MDIR.

The manufacturer must provide evidence, as required, that the quality management system is in place and that is covers the appropriate processes and is subject to independent audits.

Local license holder 

Companies without an establishment in Saudi Arabia are required to appoint a local authorized representative. Only companies that hold a valid establishment license, issued by the SFDA, and with a written mandate from the foreign manufacturer are allowed to act on their behalf. The mandate established between the manufacturer and the authorized representative shall be in writing, specify the mandated activities and be subject to the laws of the KSA.

Language

The language of the submission files shall be either in the English or Arabic language. Labeling should be in Arabic unless the device is only used by professionals, in that case English is sufficient.

Egypt

The Egyptian Drug Authority (EDA) is the pharmaceutical regulatory body of the Egyptian Ministry of Health (MOH) and it is in charge of evaluation, classification, registration of both locally produced as well as imported medical devices. Their legislation is based on the European regulation for medical devices, so your device will have the same classification in Egypt as in Europe. The non-sterile class I registration differs from the others, but in all cases you first have to make an appointment with the authorities. At your appointment you have to hand over a few copies of your submission file for review. Part of this submission file are legalized version of a Free Sales Certificate (FSC), a letter of agreement (LoA) between the manufacturer and the importer, an ISO13485 certificate and a CE or FDA approval.

Any product with codes or references should be mentioned either in the CE Certificate or in the Free Sales Certificate.

Local license holder 

Companies without an establishment in Saudi Arabia are required to appoint a local authorized representative. Only companies that hold a valid establishment license, issued by the SFDA, and with a written mandate from the foreign manufacturer are allowed to act on their behalf. The mandate established between the manufacturer and the authorized representative shall be in writing, specify the mandated activities and be subject to the laws of the KSA.

Language

The language of the submission files shall be either in the English or Arabic language. Labeling in English is a must however Arabic is obligatory for layman products.

South Africa

The Medicines Control Council (MCC) is the authority responsible for medical device vigilance and quality control and controls all manufacturing, importation and distribution of medical devices and IVDs based on the amended Medicines and Related Substances Act 101 of 1965. The South African medical device classification system depends on the risk of the device and knows the categories Class A to Class D where Class A is low risk and Class D is high risk. Class A is exempt from registration, and when importing a Class C or D or IVD, the manufacturer should possess at least one pre-market approval from the following authorities: Australian, Brazilian, Canadian, European, Japanese, or American. 

The license to manufacture, import, export or distribute will be valid for a period of five years.

Local license holder 

Companies without an establishment in South Africa are required to appoint a local authorized representative with the knowledge and responsibility to ensure that the correct procedures are followed. This authorized representative needs to have a written mandate from the foreign manufacturer to be able to act on their behalf. 

Language

The language of the submission files shall be in English, if originals are in another language a translation should be added. Minimum information should be in English like for example product description and intended use.

What can we do for you?

Registration support in Saudi Arabia

 

Registration support in Egypt

 

Registration support in South Africa

 

Local independent license holding Saudi Arabia

 

Local independent license holding Egypt

 

Local independent license holding South Africa

 

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