Ghad sfda. SFDA Medical Device Registration 2021

for Local Markets Control electronic Services was designed to build a database for all food establishments such as food manufacturers, warehouses and distribution centers and food items in the Kingdom of Saudi Arabia	Risk management report and plan• Sample of the labeling containing an indication that the medical device is intended for demonstration or training purposes only e
However, regulating authority also states that the sample application form provided as an annex to the guidance could be used for reference purposes only — for example, to evaluate the scope of information to be provided and to prepare it in advance before filing the application, while the actual application form could be accessed only via the GHAD system	Product label, which must meet Labelling criteria of SFDA• it is also include clearance service for cosmetic products coming through Saudi ports

SFDA: Importation Requirements of Devices Intended for Demonstration or Training Purposes Only

New guidance for innovative devices and standards The SFDA also released two new guidance documents.

Eservices: To assist medical device manufacturers failing to comply with new requirements in the time, SFDA has postponed the reinforcement of the new system from December 26, 2019 to January 1, 2021 and then to July 1, 2021
SFDA Medical Device Registration 2021: Thereafter, all applications would be accepted through TFA Technical File Assessment route
Eservices: Country Saudi Arabia specific statements templates from SFDA• The new regulations MDS-G5 The published MDS-G5 Guidance on Requirements for Medical Device Listing and Marketing Authorization Requirements describes the conditions to be assessed by the authority when deciding on the possibility of marketing authorization required by the medical device manufacturer or its authorized representative to be allowed to place the device on the Saudi market

that specifies the designation criteria for innovative medical devices and outlines a priority review procedure for them, with the stated intention of maintaining both safety evaluation and rapid market access	Country Saudi Arabia specific declaration of conformity• A copy of the Bill of Lading or the Air WayBill if applicable
The sample application form provided by the SFDA is divided into 5 sections depending on the type of information to be indicated	Applicant action is important to ensure that they maintain copies of the current applications and documents from the old SFDA system before all these old systems closed, before 26 December 2019

Country Saudi Arabia specific statements templates from SFDA• Identify the SFDA medical device classification.

Saudi Arabia: However, it is pertinent to mention that the SFDA reviewer may ask for additional requirements or information that companies must furnish to satisfy their query
SFDA Medical Device Registration 2021: SFDA medical device registration and approval• As it is stated in the document, its scope covers the following cases:• At the same time, in order to be allowed to import such devices, an interested entity shall obtain the appropriate importation license
New regulations for the Saudi Medtech Market: Evidence of registration in reference jurisdictions Direct Route Requirements• By the end of 2021, the registration requirements are expected to become more complex with the heavy adaptation of the latest global standards