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With our wide range of medical devices certifications and approvals, SGS is capable of offering you the complete testing and certification services for nearly all regulatory criteria and markets.

We have set up our own medical safety testing laboratories, EMC and wireless testing laboratories. Related services like safety, performance testing and certification services are provided for importers and exporters.

Our accreditations include:

*       SGS has two notified bodies for CE marking, both are under 93/42/EEC (Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices)

*       National Accreditations: UKAS ISO 13485:2003, CMDCAS for Canada, JPAL for Japan, FDA site inspections for USA, INMETRO for Brazil and schemes for Taiwan, Australia and Hong Kong

*       CB Notified Body and CB Certification Body


*       Approval for Overlapping EC Directives: Personal Protective Equipment, Pressure Equipment, Non Automatic Weighing Equipment and R&TTE

Our testing services include:

*       EU/International Product Safety, EMC, Performance testing and the tests according to EN 60601 and EN 61010 series

*       North American Product Safety (NRTL)

*       FDA Data Report for 510(k) Submission, FDA 510(k)

*       Wireless Testing, R&TTE, FCC, international type approval and more

SGS offer you the comprehensive medical devices testing services.

Main product type and test standards:

Product Type

Standards

Medical electrical
equipment Products
under MDD
93/42/EEC General

IEC/EN/UL 60601-1
IEC/EN 60601-1-2

In vitro diagnostic
medical equipment
Products under
IVD 98/79/EC General

IEC/EN/UL 61010-1
IEC/EN 61010-2-101
IEC/EN 61010-2-081
IEC/EN 61326-1
IEC/EN 61326-2-6

Medical electrical systems

IEC/EN 60601-1-1

Alarm systems in
medical electrical
equipment and
medical electrical systems

IEC/EN 60601-1-8

Medical electrical equipment
and medical electrical
systems used in the home
healthcare environment

IEC/EN 60601-1-11

Multiparameter patient
monitoring equipment
(Electrocardiographic monitoring,
Sphygmomanometer, Multifunction
patient monitoring, Pulse
oximeter equipment,
Electrical thermometers)

IEC/EN 60601-2-27
IEC/EN 60601-2-30
IEC/EN 60601-2-34
IEC/EN 60601-2-49
ISO 9919
EN 12470-4
EC 13

Clinical thermometer

EN 12470-3
EN 12470-5

Sphygmomanometer

EN 1060-1
EN 1060-3

Hospital beds

IEC/EN 60601-2-38
IEC/EN 60601-2-52

Nerve and muscle stimulator

IEC/EN 60601-2-10

Diagnostic and therapeutic
laser equipment

IEC/EN 60601-2-22

Blood-glucose monitoring systems

ISO 15197

Endoscopic equipment

IEC/EN 60601-2-18

Surgical luminaries and
luminaries for diagnosis

IEC/EN 60601-2-41

Electrocardiographs

IEC/EN 60601-2-25
IEC/EN 60601-2-51
EC 11






Restricted Substance Testing Services

RoHS 2.0 (2011/65/EU) was published in July 2011. The applicable medical devices which are driven by electro-power fall into 93/42/EEC and 98/79/EC. Medical devices and In Vitro Diagnostic (IVD) medical devices shall comply with the directive.

Apart from above mentioned testing services, SGS provides restricted substance testing service for clients to comply with RoHS 2.0 and REACH requirements, and helps you to manage the hazard substances. We offer you the one-stop-solution for your medical devices business.

Please do not hesitate to contact us for further information.

Hong Kong
email

Mr. Patrick Yung
t: +852 2334 4481 ext. 1225


Mr. Raymond Chow
t: +852 2774 7103


Ms. Katrina Lee
t: +852 2774 7413