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The evolving regulatory landscape for medical devices in Saudi Arabia

This article was originally published in SRA

Executive Summary

Saleh S Al Tayyar of the Saudi Food and Drug Authority explains Saudi Arabia's medical device rules and reports on the impact of recent regulatory change.

The Saudi Food and Drug Authority has been working for several years now on transforming the market for medical devices in Saudi Arabia from one where there were no regulations at all into a well-regulated one.

Today, Saudi Arabia's regulatory framework for medical devices is based on the Medical Devices Interim Regulation1,2; which was issued in December 2008 and which requires products to be regulated throughout their lifecycle – ie from conception and development to disposal. The SFDA meanwhile is developing a comprehensive regulatory framework and this is expected to come into effect in around four to five years.

Among other things, the new framework will allow the SFDA to approve devices that are submitted to the authority for the first time and have not yet been approved by any other jurisdiction. Currently, manufacturers that wish to place a device on the Saudi Arabian market must provide the required documents that show the product complies with the medical device regulations of at least one of the founding member jurisdictions of the Global Harmonization Task Force (ie Australia, Canada, Japan, the EU or the US). This means that the device must have been authorised for marketing in one of the GHTF founding member jurisdictions.

As of the end of the first quarter 2012, the total number of medical devices authorised by the SFDA was 1,517. Most of the SFDA approvals have been based on the EU medical device directives, while Japan's regulatory system has formed the basis of the fewest SFDA approvals.

On 14 February 2011, a new deadline came into effect regarding the need to apply for SFDA marketing authorisation to place a device on the market and the need for authorised representatives to register with the SFDA3,4. A transitional period was provided to allow the progressive placing on the Saudi market of medical devices authorised by the authority. After 31 December 2011, only medical devices with an SFDA marketing authorisation have been permitted to be put into service in Saudi Arabia; devices already in use were allowed to continue to be utilised.

The forthcoming comprehensive framework will also permit conformity assessment bodies designated by the SFDA to perform original and more comprehensive assessments, for example, for devices that have not yet received approval relating to matters such as the manufacturer's quality audit and clinical study evaluations. Currently, SFDA regulations only permit CABs to verify the documents submitted to one of the GHTF jurisdiction for the purpose of approval.

The interim regulation

In addition to permitting only GHTF-approved products on to the market, the interim regulation established a number of new rules for importers. Companies that had got used to freely importing medical devices into Saudi Arabia and marketing them now have to comply with regulations relating to, among other things, labelling, conditions of supply and/or use and post-market surveillance requirements.

The interim regulation was substantiated with a national provision which is considered an integrated part of the interim regulation. In addition, it was followed by a set of implementing rules and guidance documents. The implementing rules specify the requirements which refine and/or specify the provisions of the interim regulation and they have force of law. The guidance documents provide general guidelines and recommendations; they are not binding.

As stated above, the SFDA's medical devices framework regulates medical devices throughout the lifecycle. Figure 1 illustrates a version the World Health Organization's chart of the lifespan of a medical device5, modified to cover the scope of the medical devices sector as mandated by SFDA law to cover clearance at ports of entry.

Figure 2 provides a comprehensive map of the SFDA's medical device regulatory framework. The map illustrates the way in which the interim regulation is applied, national provisions, implementing rules and guidance documents relating to the various phases of the medical device lifespan.

The interim regulation aims to protect and maintain public health within Saudi Arabia by implementing provisions that ensure a high level of safety and health protection of patients, users and third parties with regard to the use of medical devices as they relate to their manufacture, supply and use during their lifecycle. It includes measures and assigns responsibilities to ensure that medical devices placed on the market and/or put into service in Saudi Arabia comply with all relevant provisions of the interim regulation. It applies to manufacturers, authorised representatives, importers and distributors, all medical devices and their accessories that will be supplied to Saudi Arabia, contact lenses and laser surgical equipment for cosmetic rather than medical purposes and their accessories.

Conformity assessment bodies

The SFDA has designated five CABs – BSI, TÜV SÜD, TÜV Rheinland, SGS and Cosmos – to check the validity of marketing authorisation applications. The CABs are responsible for reviewing and evaluating, on behalf of the SFDA, the adequacy of the documentation provided to the SFDA by the manufacturer or its authorised representative in order to obtain a market authorisation under the requirements of the interim regulation and its implementing rules6.

As of the end of the first quarter of 2012, the CABS had carried out assessments for 245 marketing authorisations.

Marketing authorisations and authorised reps

Under the new authorisation system, the SFDA requires foreign manufacturers to designate an established authorised representative in Saudi Arabia, to represent the manufacturer in dealing with the authority. Authorised representatives were able to start registering with the SFDA on the date the system went live, ie 14 February 20117, 8.

As of the end of the first quarter of 2012, the SFDA had authorised 198 authorised representatives. These authorised representatives represent 901 foreign manufacturers.

The authorised representative must have a separate licence for each manufacturer it represents in Saudi Arabia. Authorised representatives are required to complete the electronic licensing application form – the MDEL9, available on the SFDA website – and inform the authority without delay of any changes made to the information submitted. They must establish, document and implement the procedures necessary for them to perform their mandated tasks and attach the relevant documentation when completing the MDEL. Authorised representative licensing fees are published on the SFDA website10.

The annual licence fee is currently 5,200 Saudi Riyal ($1,386) and the lead time for issuing a licence is 20 days.

Classifications and fees

Under the interim regulation, medical devices are classified according to their original classification in the country that issued the original marketing authorisation in the GHTF founding member jurisdiction. For practical purpose they are then grouped in four fee groups. Table 1 shows the medical devices processing fee and lead time for each fee group. The fee groups, processing fees and lead times are published on the SFDA website.

Table 1. Medical device fee groups, marketing authorisation processing fees and lead time

Fee

group

 

The basis of the application for SFDA marketing authorisation

 

Three years or less (SR)

 

More than three Years (SR)

 

Lead time (working days)

 

FG(1)

 

All Class I/general in vitro diagnostic (other)/exempt IVD (based on classification of Australia's Therapeutic Goods Administration)

 

15,000

 

N/A

 

35

 

FG(2)

 

All Class II /Class IIa self-test IVD, Listable IVD

 

19,000

 

21,000

 

35

 

FG(3)

 

Class IIb / Class III/Annex II List B (IVD)

 

21,000

 

23,000

 

35

 

FG(4)

 

All other Class III/class IV/active implantable medical device/Annex II List A (IVD)/registerable IVD

 

23,000

 

25,000

 

35

 

The SFDA has faced many challenges in its efforts to transform the country's medical devices market into a well regulated sector that oversees products throughout their lifespan. For example, there has been resistance to change by device importers who had been used to following less stringent rules and manufacturers have struggled with meeting requirements concerning authorised representatives.

However, the SFDA is happy with the progress it has made so far. The interim regulation imposes a raft of obligations on manufacturers that are designed to ensure the safety and effectiveness of medical devices in Saudi Arabia while a more comprehensive set of medical device regulations is being developed for implementation in a few years' time.

Dr Al Tayyar will give a presentation on Saudi Arabia's regulatory system for medical devices at Informa Life Sciences' 6th Annual Medical Device and IVD Regulations in Asia-Pacific conference in Berlin, Germany, on 19-21 June. To register your place, click here http://www.informaglobalevents.com/CQ7093SCRIP.
To view the website click here http://www.informaglobalevents.com/CQ7093SCRIP2

References

1. Medical Devices Interim Regulation, Article Two, Issued by the Saudi Food and Drug Authority Board of Directors decree number 1-8-1429, 27 December 2008, www.sfda.gov.sa/NR/rdonlyres/8E4680B2-7F1E-4045-864C-F3A465DA895F/0/ENGLISHINTERIMREGULATION2011.PDF

2. Saudi FDA to begin device approval process from 1 Sept, Scrip Regulatory Affairs, 21 April 2010

3. Saudi FDA's revised medtech rules to apply from 14 Feb, Scrip Regulatory Affairs, 4 January 2011

4. Yeo A, "Light touch" Saudi device review regulation should stimulate the market, Scrip Regulatory Affairs, 14 March 2011

5. WHO, Medical Device Regulations, Global overview and guiding principles, 2003, www.who.int/medical_devices/publications/en/MD_Regulations.pdf

6. Implementing Rule on designation and oversight of conformity assessment bodies (MDS-IR1), Article Five, 4 January 2010, www.sfda.gov.sa/NR/rdonlyres/AC5CA167-BDDB-4609-BBE4-9844A0B133AB/0/IR12011.pdf

7. Implementing Rule on licensing of Authorized Representative (MDS-IR5), Article 42 (IIB), 14 February 2011

8. Implementing Rule on Medical Devices Marketing Authorization (MDS-IR-6), Article 13, 14 February 2011

9. Implementing rule on licensing of authorized representative (MDS-IR5), Article Seven, 14 February 2011

10. SFDA, MDS – Official Announcements, website accessed 15 May 2012, www.sfda.gov.sa/En/MedicalEquipments/Topics/MDS-Official+Announcements/

Saleh S Al Tayyar, PhD, is vice executive president of the Saudi Food and Drug Authority for Medical Devices Sector. He is also chair of the Asian Harmonization Working Party on medical devices and assistant professor at the Biomedical Technology Department, College of Applied Medical Sciences, King Saud University, Saudi Arabia.

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