Saudi Arabia and Dubai - Class III Medical Device Regulations?

[tehuff]

Hi all,
I have a request to ship our product to Saudi Arabia and Dubai. We currently have CE mark (class III product) but not FDA approval. Does anyone know the medical device regulations in either of these geographies? Are there import requirements that may also apply?

I found this info on the Saudi Network website under the Importation of Medicines and Pharmaceuticals section
"...imports of pharmaceuticals and medicinal products require a certificate issued by the Exporting country Department of Health and Human Services stating that the medicines are actually used by the public in the Exporting country under the same trade name and formula and must include the name of each product, the formula, and the date and number of the permit to manufacture them if one is required. "

Does anyone know if this also applies to Medical Devices?

Thanks!

[MIREGMGR]

In Reply to Parent Post by tehuff

I have a request to ship our product to Saudi Arabia and Dubai. We currently have CE mark (class III product) but not FDA approval.

I found this info on the Saudi Network website under the Importation of Medicines and Pharmaceuticals section
"...imports of pharmaceuticals and medicinal products require a certificate issued by the Exporting country Department of Health and Human Services stating that the medicines are actually used by the public in the Exporting country under the same trade name and formula and must include the name of each product, the formula, and the date and number of the permit to manufacture them if one is required. "

Does anyone know if this also applies to Medical Devices?

My experience to date has been that the info at www.the-saudi.net is reliable, even though unofficial, in regard to Saudi Arabia.

Yes, the requirement for a COFG/CFS does apply to medical devices. That is in fact the only requirement for qualification for import: that the medical device must be legal for sale and use in its country of origin, as certified by that nation's (not the EC's) medical device regulatory authority.

Dubai is part of UAE. My understanding is that UAE judges import applications on a case by case basis, but generally following the same approach as the Saudis, i.e. if it's legal to market and use in its country of origin, it's accepted.

I didn't do a complete search here, but one past thread you could reference is http://elsmar.com/Forums/showthread.php?t=25421.

[bio_subbu]

In Reply to Parent Post by tehuff

Hi all,
I have a request to ship our product to Saudi Arabia and Dubai. We currently have CE mark (class III product) but not FDA approval. Does anyone know the medical device regulations in either of these geographies? Are there import requirements that may also apply?

I found this info on the Saudi Network website under the Importation of Medicines and Pharmaceuticals section
"...imports of pharmaceuticals and medicinal products require a certificate issued by the Exporting country Department of Health and Human Services stating that the medicines are actually used by the public in the Exporting country under the same trade name and formula and must include the name of each product, the formula, and the date and number of the permit to manufacture them if one is required. "

Does anyone know if this also applies to Medical Devices?

Thanks!

As regards to KSA Import requirement, the Saudi Food & Drug Authority (SFDA) – Medical Devices Sector (MDS) has adopted Medical Devices Interim Regulation (MDIR), issued by Saudi Food and Drug Authority Board of Directors Decree number 1-8-1429 and Dated 27 December 2008.

The Interim applies to medical devices that fall under the definition of medical device as per Chapter One (Refer Article One of MDIR).

The manufactures, authorised representatives, importers and distributors intend to place a medical device on Saudi market, shall satisfy the following:

1. When the manufacturer is located outside the KSA, he shall appoint an authorised representative to act on his behalf (Refer chapter Four - Article Eleven, of MDIR).

2. Manufacturers established within the KSA, authorised representatives, importers and distributors of medical devices shall:

a) Register the establishments with the SFDA – Medical Devices National Registry (MDNR) by using this link http://Mdnr.sfda.gov.sa

b) List the medical devices with the SFDA – MDNR (Refer chapter Four - Article Ten, of MDIR).

3. Local manufacturers involved in distribution activities, as well as importers, distributors and authorised representatives involved in importation or distribution activities, shall apply for an establishment license. (Refer chapter Five - Article Fifteen, of MDIR) .

4. Medical devices may be placed on the market and/or put into service only if they comply with the applicable provisions of this Interim Regulation, as signified by the SFDA issuing the manufacturer with a written marketing authorisation (Refer Chapter Two – Article Four, of MDIR).

Regards
S. Subramaniam

[tehuff]

Thanks for the excellent info! As I was reviewing it, I noticed in the MDIR that approval in EU, US, Canada, Japan, or Australia is also required.

[bio_subbu]

In addition to my above post regarding KSA product import requirement, and I would like add some more comments to your question toward Dubai product registration, Dubai is part of UAE and medical Devices manufacturers must be registered with UAE Ministry of Health before you market your devices.

Companies wishing to export medical devices to UAE must have a local UAE REPRESENTATIVE or DISTRIBUTOR who holds Medical Store licensed from Ministry of Health. Imported medical Devices are subject to local registration requirements.

All the manufacturers of Class I, Class II a, Class II b, Class III and Active Implantable Devices has to be registered with UAE Ministry of Health.

The UAE local distributor must submit a registration application to MOH Drug Control Department.

A registration number will be given when an application is approved. This number will be valid for a 5 years period unless significant changes are made to the approved application data. The Director General can cancel the registration number, if any of the following takes place:

a. Based on the request of the applicants;

b. Based on evaluation or monitoring, following products may fail to meet the criteria because:

(1) they are not safe or are harmful to health,

(2) the quality is substandard,

(3) they differ from the approved label; this includes using a brand name which is originally owned by another rightful party.

(4) If submitted documents prove to be untrue

The Director will notify the registration holder in writing of the cancellation. Applications are considered complete if application forms and enclosures are filled up correctly according to the instructions. Application forms must be signed by the head of the company, the director or technical representative as indicated in the agency agreement. Indicate name of place, date, complete name of responsible person and company's seal. The exoneration process: 8-12 weeks after submission of complete documents.

For more details, please refer following guidance documents in existing thread “UAE IVD Registration (Professional Use Only, Non-A, Non-B of EU Regulation)” post # 5.

Registration of Manufacturer of Medical Device
Medical device manufacturers and products Registration flow chart
UAE Medical Devices Registration Guideline and receipt for submission of registration dossier Medical Device Product.

Regards
S. Subramaniam

[tehuff]

In Reply to Parent Post by bio_subbu

Companies wishing to export medical devices to UAE must have a local UAE REPRESENTATIVE or DISTRIBUTOR who holds Medical Store licensed from Ministry of Health. Imported medical Devices are subject to local registration requirements.

The UAE local distributor must submit a registration application to MOH Drug Control Department.

Can a US manufacturer submit the registration application to MOH? I didn't see in the guidance documents that a local distributor is required (or is it a situation where it is "highly recommended" in order to successfully register)?

[drewsky1]

Does anyone know if Dubai requires the CE mark for registration?

Thank you

[tehuff]

Dubai is in the United Arab Emirates (UAE). CE mark is not required for UAE, but a simplified registration process is available for devices that have received approval from a recognized regulatory agency such as those in Europe, Canada, US, Australia or Japan.