medical device approval in saudi arabia and egypt

ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com

Medical device approval in Saudi Arabia and Egypt

Medical Device Approval in Saudi Arabia and Egypt



Key Points: Kingdom of Saudi Arabia (KSA)

• KSA healthcare market characteristics • Device classification issues in the KSA

• Leveraging GHTF approvals for registration in the KSA • KSA Authorized Representation requirements

• Medical Device Marketing Authorization (MDMA) applications • Required registration documentation

• Timelines *All information current as of January 9, 2013.



Kingdom of Saudi Arabia (KSA) Market Characteristics

2010 Healthcare Spending:

$19 billion

Per capita: $680

2005 > 2010: 67% spending increase

Population: 27,448,000

Source: World Health Organization National Health Account Database



KSA Registration: Prerequisites

Before you can begin your KSA medical device registration process, you must obtain approval from at least one founding

Global Harmonization Task Force (GHTF) member (The US, Canada, Australia, the European Union or Japan).



Device Classification in the KSA

How your device is classified in your reference GHTF market determines how the Saudi Food and Drug Authority (SFDA)

will classify your device in the KSA.

Lowest risk Highest risk



KSA In-Country Representation Requirements

Medical device manufacturers with no local presence in the KSA must

appoint a Saudi Arabia Authorized Representative (AR) to manage

their registration process with the SFDA.

Your AR must hold a valid Authorized

Representative License issued by the SFDA.



Saudi Arabia AR Responsibilities Your Saudi Arabia AR acts as your liaison with Saudi regulators during your

registration and commercialization effort in the KSA. Key AR duties include:

•Submitting your device registration materials to the SFDA

•Administering all pertinent registration fees

•Notifying the SFDA of any changes to your device

•Coordinating adverse event reporting to authorities with you and your distributors

•Supporting device recall or field safety corrective actions if necessary



Saudi Arabia AR Responsibilities, cont’d.

• All registration application

documents are submitted using the KSA’s Medical Device Marketing Authorization (MDMA) system.



Required MDMA Application Materials The following documents must be included in your KSA registration

application:

•Manufacturer and Saudi Arabia AR details

•Medical device information including intended use, labeling, instructions for use and marketing materials

•Documents supporting valid registration in your reference GHTF market(s)

•Statement attesting that you will comply with the KSA’s National Centre of Medical Devices Reporting (NCMDR) rule that any field safety corrective actions concerning your device be reported to Saudi authorities



MDMA Application Submission and Commercialization

For lower-risk devices: (Classes I, II, IIa, IIb)

Once your AR has submitted your MDMA application, you may begin marketing your device in the KSA prior to obtaining formal regulatory approval*

For higher-risk devices: Following submission of your MDMA application by your AR, you must first obtain formal MDMA certification from the SFDA before your device can be sold in the KSA

*Temporary measure currently allowed as of January 9, 2013, but subject to change by the SFDA at any time.



SFDA Review Timelines

Official SFDA timeframes for application reviews are 35 business days.



SFDA Registration Renewal Requirements

For low-risk (Class I) devices: SFDA registration is valid for three years

For all other devices: SFDA registration is valid for the length of time that your registration is valid in your reference GHTF market, or, where that registration doesn’t expire, for three-years



Key Points: Egypt

• Egyptian market overview • Leveraging CE Marking for registration in Egypt

• Egypt Registration Holder and “Scientific Office” requirements • Certificate of Free Sale requirements

• Quality System certification • Documentation needed for registration • Scientific technical committee reviews



Egyptian Market Characteristics

Total Healthcare Spending (2010):

$3.6 billion

Per capita healthcare spending:

$48

Healthcare spending as % of GDP:

4.7%

Population: 81,121,000

Source: World Health Organization National Health Account Database



Market Entry in Egypt

• Egypt’s medical device regulatory system is based largely on European Union medical device directives.

• The Central Administration of Pharmaceutical Affairs (CAPA) uses a medical device classification system similar to that in

the EU. Class I (non-

sterile, non-measuring)

Class I (sterile, measuring) Class IIa Class IIb Class III



CAPA Quality Management System Requirements

Quality system certification for ISO 13485 must be obtained prior to registering your medical device in Egypt.



Appointing an Egypt Registration Holder

If you have no licensed office in Egypt, you must appoint an authorized representative

known as an Egypt Registration Holder (ERH) to

manage your registration effort with the CAPA.



ERH Responsibilities Your ERH manages your device registration and interacts with

the CAPA on your behalf. ERH duties include:

•Establishing a Scientific Office in Egypt with an Egyptian manager and a CAPA-licensed medical store to hold samples of your product

•Submitting your Technical File and registration documents to the CAPA for review

•Administering all fees related to registration

•Notifying the CAPA of any changes to your device

•Coordinate adverse event reporting, field safety corrective actions and recalls with you and your distributors if necessary

•Assisting with your device registration renewals (required every 10 years)



Required Registration Documents •Proof of quality system certification •Commercial and generic names of your

device

•Certificate of Free Sale from your home country

•Detailed device description and intended use information

•Letter of authorization for your ERH and/or distributors

•Finished product specification data

•Declaration of Conformity •Primary and secondary packaging details

•Copy of contract between manufacturer and commercializing firm, if applicable

•Summary of pre-clinical and clinical study data, if applicable



The CAPA Registration Process Your ERH emails the CAPA to request a review appointment

CAPA responds with meeting date and time

CAPA accepts your registration application and begins first review

CAPA emails requests for more information following first review



The CAPA Registration Process, cont’d.

Scientific Committee Review, if necessary

Applicant replies to CAPA requests and final review begins

CAPA emails any final requests for information

Applicant completes Technical File, CAPA registration committee issues approval and marketing authorization issued



CAPA Review Timelines

• Assembly of application materials: 30 to 60 days • Setting up CAPA review appointment: up to 9 months • Final CAPA decision: 3 to 5 months, unless Scientific

Committee review is ordered



Additional Resources KSA medical device regulations:

http://www.emergogroup.com/resources/regulations-saudi-arabia Egypt medical device regulations:

http://www.emergogroup.com/resources/regulations-egypt Emergo Group services for the KSA:

http://www.emergogroup.com/services/saudiarabia Emergo Group services for Egypt:

http://www.emergogroup.com/services/egypt

Ann Marie Boullie Emergo Group|Director of Business

Development US office: +1.512.327.9997

Emad Elmasry Emergo Group|Managing Director

Middle East Cairo Office: +20.2.251.777.82

http://www.emergogroup.com/resources/regulations-saudi-arabia

http://www.emergogroup.com/resources/regulations-egypt

http://www.emergogroup.com/services/saudiarabia

http://www.emergogroup.com/services/egypt



Emergo Group at Arab Health 2013 Webinar presenters Ann Marie Boullie and Emad Elmasry as well as other

Emergo Group managers will be attending the 2013 Arab Health conference 28-31 January in Dubai.

Meet Emergo Group representatives at Hall 1 Booth G54.

http://www.arabhealthonline.com/home/

http://ww1.dothealth.com/exhibitions/arabhealthonline/

medical device approval in saudi arabia and egypt

Health & Medicine