Registry Insights · SFDA

Saudi Arabia Medical Device Registry Statistics

Name: Saudi Arabia Medical Device Registry Statistics
Creator: Pure Global
License: https://creativecommons.org/licenses/by/4.0/

Aggregated from 231,070 official SFDA registration records covering 7,710 manufacturers. Data as of 2026-08-05.

The Saudi Food and Drug Authority (SFDA) regulates medical devices in Saudi Arabia. As of 2026-08-05, this registry snapshot contains 231,070 registration records, of which 230,612 are currently active and 458 are cancelled, expired, or withdrawn.

The largest manufacturer by active registrations is Roche Diagnostics GmbH with 4,065 registrations.

Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Saudi Arabia device database, or see our methodology for how the data is collected.

230,612

Active registrations

7,710

Manufacturers

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Registrations by Risk Class

SFDA risk classification of active registrations

Risk class	Registrations	Share
IVD – General	51,990	22.5%
Class IIa	41,011	17.8%
Class I	38,863	16.9%
Class IIb	30,810	13.4%
Class III	11,675	5.1%
Class II	11,662	5.1%
Class IV	48	0.0%

Registrations by Product Category

Largest product category groups among active registrations

Product Category	Registrations	Share
Medical Device	154,032	66.8%
Chemicals	59,453	25.8%
IVD	7,142	3.1%

Top 50 Manufacturers in Saudi Arabia

Ranked by active registrations. Company names are normalized; affiliated legal entities are listed separately, as registered.

Rank	Manufacturer	Registrations	Top categories
#1	Roche Diagnostics GmbH	4,065	Chemicals IVD
#2	Aesculap AG	2,967	Medical Device
#3	ASANUS Medizintechnik GmbH	2,930	Medical Device
#4	Gimmi GmbH	2,507	Medical Device
#5	Siemens Healthcare Diagnostics Inc.	2,389	Chemicals IVD
#6	Synthes GmbH	2,377	Medical Device
#7	Smith & Nephew Inc.	2,332	Medical Device
#8	COOK INCORPORATED	2,237	Medical Device
#9	Gebrueder Martin GmbH & Co. KG	1,812	Medical Device
#10	Leica Biosystems Newcastle Ltd	1,771	Chemicals
#11	Covidien llc	1,560	Medical Device
#12	Abbott Ireland Diagnostics Division	1,504	Chemicals IVD
#13	Medtronic, Inc.	1,483	Medical Device IVD
#14	Stryker GmbH	1,445	Medical Device
#15	Maquet Cardiopulmonary GmbH	1,383	Medical Device
#16	CareFusion	1,376	Medical Device
#17	Abbott GmbH. and Co. KG	1,116	Chemicals
#18	Siemens Healthcare Diagnostics Products Limited	1,067	Chemicals IVD
#19	Shenzhen New Industries Biomedical Engineering Co., Ltd ( SNIBE )	1,053	IVD Chemicals
#20	Medtronic Sofamor Danek USA, Inc.	1,035	Medical Device
#21	Medtronic XOMED, Inc	1,033	Medical Device
#22	Medos International SARL	1,016	Medical Device
#23	Arthrex, Inc	1,008	Medical Device
#24	Olympus Winter & lbe GmbH	980	Medical Device
#25	Boston Scientific Corporation	962	Medical Device
#26	Molnlycke Health Care AB	936	Medical Device
#27	GEUDER AG	895	Medical Device
#28	Institut Straumann AG	888	Medical Device
#29	KLS Martin SE & Co. KG	871	Medical Device
#30	Zimmer Inc.	869	Medical Device
#31	DePuy Ireland UC	860	Medical Device
#32	Rebstock Instrument GmbH	821	Medical Device
#33	Cell Marque Corporation	820	Chemicals
#34	Olympus Medical Systems Corp.	820	Medical Device
#35	ALTATEC GmbH	819	Medical Device
#36	DePuy Orthopaedics, Inc.	813	Medical Device
#37	Medtronic Navigation, Inc.	782	Medical Device
#38	Phadia AB	755	Chemicals
#39	Chromsystems Instruments&Chemicals GmbH	748	Chemicals IVD
#40	Stryker Instruments	710	Medical Device
#41	Nobel Biocare AB	676	Medical Device
#42	RZ-Medizintechnik GmbH	638	Medical Device
#43	Medline Industries, LP	631	Medical Device
#44	Agilent Technologies Singapore (International) Pte Ltd.	606	Chemicals IVD
#45	Mast Group Ltd	592	Chemicals
#46	Becton Dickinson and Company	573	Chemicals IVD
#47	Microgenics Corporation	569	Chemicals IVD
#48	Beckman Coulter Inc.	561	Chemicals IVD
#49	Dimeda Instrumente GmbH	561	Medical Device
#50	nopa instruments Medizintechnik GmbH	557	Medical Device

About this data: statistics are computed from the official Saudi Food and Drug Authority registry as mirrored in the Pure Global database (231,070 records; page generated 2026-08-05). “Active” excludes cancelled, expired, and withdrawn records. Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.

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