The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
class iii medical device, dubai, regulations and regulatory requirements, saudi arabia, ce mark and ce marking, medical devices (general)
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  #1  
Old 26th July 2010, 11:45 AM
tehuff tehuff is offline
Involved in Discussions

 
Registration Date: Jul 2010
Location: United States
 
Posts: 53
Thanks Given to Others: 12
Thanked 10 Times in 8 Posts
Karma Power: 21
Karma: 60
tehuff has less than 100 Karma points so far.
Please Help! Saudi Arabia and Dubai - Class III Medical Device Regulations?

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!

Last edited by tehuff; 26th July 2010 at 11:51 AM.

Sponsored Links
  #2  
Old 26th July 2010, 01:32 PM
MIREGMGR MIREGMGR is online now
Appreciated Information Resource

 
Registration Date: Aug 2008
Location: SE Michigan, USA
 
Posts: 3,296
Thanks Given to Others: 1,145
Thanked 2,440 Times in 1,500 Posts
Karma Power: 404
Karma: 25983
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
Re: Saudi Arabia and Dubai - Class III Medical Device Regulations?

Quote:
In Reply to Parent Post by tehuff View Post

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.
Sponsored Links

  #3  
Old 26th July 2010, 02:19 PM
bio_subbu's Avatar
bio_subbu bio_subbu is offline
S. Subramanian

 
Registration Date: Aug 2007
Location: India
 
Posts: 581
Thanks Given to Others: 210
Thanked 884 Times in 365 Posts
Karma Power: 96
Karma: 5205
bio_subbu is appreciated, and has over 1700 Karma points.
bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.
Send a message via Skype™ to bio_subbu
Re: Saudi Arabia and Dubai - Class III Medical Device Regulations?

Quote:
In Reply to Parent Post by tehuff View Post

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
Thank You to bio_subbu for your informative Post and/or Attachment!
  #4  
Old 26th July 2010, 03:23 PM
tehuff tehuff is offline
Involved in Discussions

 
Registration Date: Jul 2010
Location: United States
 
Posts: 53
Thanks Given to Others: 12
Thanked 10 Times in 8 Posts
Karma Power: 21
Karma: 60
tehuff has less than 100 Karma points so far.
Re: Saudi Arabia and Dubai - Class III Medical Device Regulations?

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.
  #5  
Old 27th July 2010, 03:39 AM
bio_subbu's Avatar
bio_subbu bio_subbu is offline
S. Subramanian

 
Registration Date: Aug 2007
Location: India
 
Posts: 581
Thanks Given to Others: 210
Thanked 884 Times in 365 Posts
Karma Power: 96
Karma: 5205
bio_subbu is appreciated, and has over 1700 Karma points.
bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.
Send a message via Skype™ to bio_subbu
Re: Saudi Arabia and Dubai - Class III Medical Device Regulations?

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
Thanks to bio_subbu for your informative Post and/or Attachment!
  #6  
Old 28th July 2010, 10:19 AM
tehuff tehuff is offline
Involved in Discussions

 
Registration Date: Jul 2010
Location: United States
 
Posts: 53
Thanks Given to Others: 12
Thanked 10 Times in 8 Posts
Karma Power: 21
Karma: 60
tehuff has less than 100 Karma points so far.
Re: Saudi Arabia and Dubai - Class III Medical Device Regulations?

Quote:
In Reply to Parent Post by bio_subbu View Post

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)?
  #7  
Old 29th November 2012, 09:56 AM
drewsky1 drewsky1 is offline
Involved in Discussions

 
Registration Date: Apr 2010
 
Posts: 107
Thanks Given to Others: 1
Thanked 2 Times in 2 Posts
Karma Power: 27
Karma: 25
drewsky1 has less than 100 Karma points so far.
Re: Saudi Arabia and Dubai - Class III Medical Device Regulations?

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

Thank you
  #8  
Old 29th November 2012, 11:10 AM
tehuff tehuff is offline
Involved in Discussions

 
Registration Date: Jul 2010
Location: United States
 
Posts: 53
Thanks Given to Others: 12
Thanked 10 Times in 8 Posts
Karma Power: 21
Karma: 60
tehuff has less than 100 Karma points so far.
Re: Saudi Arabia and Dubai - Class III Medical Device Regulations?

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.
Thanks to tehuff for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Mandatory Language Requirements Saudi Arabia NewRegMan Other Medical Device Regulations World-Wide 12 1st March 2012 10:42 PM
FTC "Made In U.S.A" Labeling Rules vs. Saudi Arabia's "Country of Origin" Regulations tosborn Other Medical Device Regulations World-Wide 6 19th November 2010 07:38 PM
Equipment Cleaning Validation Requirements - Medical Device Class II or Class III RMV09 Other Medical Device and Orthopedic Related Topics 5 25th March 2010 02:26 AM
IFU for Canada Class III Medical Device Slayer_ch Canada Medical Device Regulations 4 11th June 2009 08:31 AM
Medical Device Directive, Conversion from class IIb to class III ISO MAN EU Medical Device Regulations 4 17th November 2008 09:50 AM



The time now is 10:21 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272