Saudi FDA issues guidance on approving devices ahead of 14 Feb rules
This article was originally published in RAJ Devices
The Saudi Food and Drug Authority has issued five guidelines providing information on revised regulations for medical devices that are slated to come into effect on 14 February1,2.
The guidelines have been issued as part of the SFDA's ongoing efforts to implement an interim medtech regulatory framework covering marketing authorisation and post-marketing surveillance of medical devices. The SFDA had initially set a deadline of September 20103 to begin the device approval process under the interim medtech regulations, but later postponed this to 14 February.
From the February deadline, medical devices may be placed on the market if the SFDA has issued the manufacturer with a written marketing authorisation.
For medical devices that are already on the market but do not have an SFDA marketing authorisation, the agency will allow these on the market until 14 August, after which these devices will require an SFDA marketing authorisation. After 31 December, only those medical devices that have an SFDA marketing authorisation may be put into service (as opposed to being placed on the market; the agency distinguishes between these terms in its implementing rules).
Specifically, the latest guidelines offer information relating to medical device importers and distributors4, local manufacturers5, medical device authorised representatives6, overseas manufacturers7 and marketing authorisation procedures8.
The guidelines say that a marketing authorisation will be required for: all medical devices irrespective of their risk class; and contact lenses and laser surgical equipment intended for cosmetic and medical purposes. Marketing authorisation will also be required for accessories to medical devices. It will not be required only in cases where the staff of a health facility designs and constructs medical devices for use within that facility.
The SFDA explains that an overseas device manufacturing company, before applying for a marketing authorisation through its authorised representative, will need to ensure that its products comply with the regulatory requirements in place in any of the founding member regions of the Global Harmonization Task Force (namely, the US, Australia, Canada, Japan or the EU).
The SFDA notes that not all GHTF founding members regulate products to be used only for cosmetic purposes (eg contact lenses and laser surgical equipment) as medical devices. However, as these products are still covered by the Saudi interim medtech regulations, applications to the SFDA for marketing authorisation must be based on an existing authorisation from one of the founding member jurisdictions that does classify such products as medical devices.
The overseas manufacturer may use the marketing authorisation in these regions as the basis of its application to the SFDA. In addition, these devices must comply with Saudi-specific requirements concerning labelling and conditions of supply/use. After a medical device has been granted an SFDA marketing authorisation, the manufacturer's authorised representative will be required to provide information about the product to the Medical Device National Registry (MDNR).
In cases where an overseas manufacturer intends to market products that fall within more than one device category or group, it may either designate a single authorised representative for all the devices it intends to market, or designate a different authorised representative for each device category or group.
The SFDA clarifies that an authorised representative is allowed to represent more than one manufacturer provided the necessary mandates and licences have been granted. Each authorised representative will require an Establishment National Registry Number issued by the SFDA – forms for which are provided on the agency's website.
Each importer and distributor will also require an Establishment National Registry Number before they can apply for an establishment licence (which needs to be renewed annually), and to import or distribute medical devices within the country.
References
1. SFDA-MDS Official Announcements, Guidance documents, published online 26 January 2011, www.sfda.gov.sa/En/MedicalEquipments/Topics/MDS-Official+Announcements/
2. Saudi FDA's revised medtech rules to apply from 14 Feb, Regulatory Affairs Medtech, 4 January 2011
3. Saudi FDA to begin device approval process from 1 Sept, Regulatory Affairs Medtech, 21 April 2010
4. SFDA, Guidance for Medical Device Importers and Distributors (MDS – G1), www.sfda.gov.sa/NR/rdonlyres/3E573F2C-E983-40F5-B4A9-2F50992D76E5/0/guidanceforMDimportersanddistributers.pdf, 26 January 2011
5. SFDA, Guidance for Local Manufacturers (MDS – G2), www.sfda.gov.sa/NR/rdonlyres/FA8546BF-8FE2-4757-ABCD-477B8A359BDC/0/guidanceforlocalmanufacturers.pdf, 26 January 2011
6. SFDA, Guidance for Medical Device Authorised Representatives (MDS – G3), www.sfda.gov.sa/NR/rdonlyres/8F277DF0-3C4C-4C1B-AD0E-03FB3E6D4576/0/guidanceforMDauthorisedrepresentatives.pdf, 26 January 2011
7. SFDA, Guidance for Overseas Manufacturers (MDS – G4), www.sfda.gov.sa/NR/rdonlyres/8077A643-55D0-4A00-B84E-E70DDF3855F3/0/guidanceforoverseasmanufacturers.pdf, 26 January 2011
8. SFDA, Guidance on Marketing Authorization Procedures (MDS – G5), www.sfda.gov.sa/NR/rdonlyres/11961CEB-1019-4777-B485-B6D2C1DDEA88/0/guidanceonmarketauthorizationprocedure.pdf, 26 January 2011