29/08/2016
Sirs / Chamber respected participants
Peace, mercy and blessings of God
Asharqia Chamber sends you its finest greetings and inform you of the receipt of the letter of Saudi Chambers Council Resolution (L.o / d / 2983) the date (21/10/1437 e), referred it to the Executive chief Vicar of the medical devices and products, General Authority for Food and Drug number (33 816 / GS ) on (10/16/1437 H), containing what has been recieved of information showing the existence of laser devices used in some women clinics in health centers in health care (to tighten the vagina) and it turned out to follow through the committee investigation that these devices have some of the medical claims that have not been verified, In addition to the lack of these devices for marketing authorization certificate from the Committee until now .
Thus , the Board hopes of the health sector, companies and medical equipment and supplies, to stop the announcement of these devices, and not use them until the release authority for the final situation of them, in order to avoid the occurrence of any side effects might be caused by these devices after use, besides the current coordination between the Committe and The Ministry of Health in this regard, while informing that the list of medical devices stated not to advertise any product or medical device unless they have a permition from the Committe, and it must be certain that when buying any device or medical product from the facility it already meets the requirements of the Committe including:
A license for the facility (MDEL) of the Committe for the exercise of the associated Council deliberation medical devices activity.
Marketing authorization certificate for each of the products (MDMA).
Registration at the National Center for reports of medical devices and products https://nomdr.sfde.gov.sa For more information about this communicate the phone number: (0112038222) ext (2499) or e-mail MDS@sfda.gov.sa)).
