Currently, there is no list; and soon, SFDA will enter into agreements with some companies regarding the issuance of certificates of compliance for imported cosmetic products and will be duly announced after approval. It is essentially a Saudi company with an agreement signed with a legal medical device manufacturer to act on their behalf in Saudi Arabia. The authorized representative company does not necessarily hold commercial rights in the market, but facilitates the marketing and sales process by ensuring compliance with the legislation. For more information, visit the SFDA medical device sector websitewww.sfda.gov.sa/en/medicaldevices/Pages/default.aspx All foreign manufacturers must appoint an authorized KSA (AR) representative. This AR assumes all the tasks provided by the transitional arrangements on behalf of the manufacturer and represents them with the SFDA. One of these tasks is the use of marketing authorizations. The AR control must be completed before an application of the device can be made. The appointment is based on an establishment license for the AR and a specific agreement or mandate between the two parties. The SFDA Guidance for Medical Devices Authorized Representatives contains a recommended model agreement. The SFDA has published a model of authorized agreement of certain medical devices, which can be used as it is, as it has minimum clauses of requirements. Note: the validity of the AR agreement is at least two years.
Note that the validity of the AR license issued must not exceed the validity of the AR agreement. The applicant can apply for an AR for a period of one year, two years, etc., and taxes are calculated accordingly. Can I choose more than one AR? If you market multiple devices that fall into different categories (for example. B, individual devices compared to electromechanical devices), you can have different ARs for each category, although this is not necessary. You can use an AR for all product categories. Manufacturers may also have more than one AR for the same product category by indicating the product range represented by each AR within each AR mandate. Who owns the MDMA authorization – the AR or the manufacturer? MDMA is issued on behalf of the manufacturer; The manufacturer who owns the registration. In this article, we discuss the definition of AR, its role and how to allocate one for your business. Can we choose a distributor like our representative at KSA? As a first step, overseas medical device manufacturers appoint a local agent (AR) who obtains the AR license to advance the registration of medical devices in KSA. “It is therefore important that any producer wishing to place goods on the Saudi market immediately participates in the procedure established by the SFDA.
It is likely that non-authorization or authorization could prevent products from entering or selling or being used in the country. The Certificate of Compliance is issued and certified by a certification company accredited in the country of origin and the certificate must indicate that the product complies with Saudi standards issued by the Saudi Standards, Metrology and Quality Organization (SASO). In August 2011, the SFDA stressed the importance of complying with the new rules for CABs working with them. They asked CABs such as SGS to contact all customers and manufacturers and inform them of the new rules and the urgency of compliance. To quote the SFDA-NewsBulletin: Submit your medical device or your DVI registration to the SFDA – For non-sterile/non-measurers Class I devices, the manufacturer has the option to register devices via the National Medical Device Registry (MDNR) via distributor/importer. The MDNR road does not require an AR. SGS considers this to be an application to the use of medical devices already legally imported into the KSA.