Medical Device Assurance Testing, Certification & Auditing

Intertek supports the needs of blend of medical device stakeholders like device manufacturers, distributors, hospitals and care-giving institutes through the execution of laboratory testing and on-site testing & certification - Intertek is your trusted Total Quality Assurance partner.

Time to market starts with trusted partnership, and for more than 50 years Intertek has been partnering with Medical Device manufacturers globally to provide end-to-end assurance solutions, testing, inspection and certification.

Intertek Assurance and Consulting services provided for medical devices are carried out by a team of Medical Device Experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body and Certification activities.


Regulatory Requirements for Medical Equipment

In-house Testing & Evaluation per Regulatory Requirements for Medical Devices

  • Bring your medical device & in-vitro diagnostic medical device (IVD) to market with Intertek's total solutions and one-stop services in IEC 60601 series, IEC 80601 series, IEC 61010 series, IECEE CB Scheme & ETL/cETL certification, ranged from, bu tnot limited to safety, performance, usability, software life cycle processes & home healthcare requirements.

Local Pre-test Services for Safety & EMC

  • Identify the device issues in the earlier product design and development stage realized by the test sites near you, giving you a smoother experience in the official compliance testing. 

Medical Devices Testing Solutions

On-site Medical Device Testing Solutions
  • Fulfill your customer procurement / tender requirements locally at the use site covering electrical and EMC testing against IEC 60601 & 61010 series.
 
OFCA Type Approval of Radio Medical Equipment
  • Intertek is one of few Local Certification Bodies (LCB) designated by OFCA of HKSAR government to issue LCB certification in accordance with both Voluntary Certification Scheme (VCS) for Connected Medical Devices and Medical Implant Communication Systems (MICS), and Compulsory Certification Scheme (CCS) for Industrial, Scientific & Medical (ISM) equipment.
 
On-site Electro-magnetic Frequency (EMF) / Radio Frequency (RF) Exposure Measurement
  • Peace of mind to medical device operators and patients from excessive exposure of RF energy in accordance with the exposure limits stipulated by International Commission on Non-Ionizing Radiation Protection (INCIRP).
 

Reach your target markets quickly and cost-effectively with Electrical, Electromagnetic Compatability (EMC), Bluetooth and Wireless Testing, Cyber Security, Software and Mobile Application testing and certification for your medical device.


Cybersecurity for Connected Medical Devices & Medical IoT (MIoT)


  • Securing your connected medical devices and patient data through a wide range of assessments - UL 2900-2-1 adopted by US FDA, vulnerability assessment & penetration testing of the devices, web & mobile applications & backend.
 

For inquiries, please contact hkmarketing@intertek.com

 

We can provide EMC testing to meet your compliance needs during the development cycle. Intertek Hong Kong has 3 Meter Chamber available to support your testing needs. We provide EMC Pre-compliance Scans, Radiated Emissions & Radiated Immunity and ESD testing. 

ESD testing can determine whether a product is compliant with IEC 61000-4-2 and can help identify ESD reducing measures for manufactures. 

IEC 61010 is a widely accepted series of safety standards for medical, laboratory and measurement equipment. The purpose of the standard is to ensure that hazards to the operator and surrounding area are reduced to a tolerable level.

For particular circumstances, we can offer on-site testing and risk assessment to fit into your flexibility. Our experts can help to ensure your equipment remains in compliance with the latest revision of IEC 61010.

Intertek Hong Kong is an accredited Local Certification Body, LCB, for Hong Kong's Communications Authority, CA. The technical specifications for medical equipment emitting radio frequency energy intentionally are prescribed by the CA.

We provide certification service for regulated equipment to be used and sold in the Hong Kong market. The technical specifications are mainly set for the purposes of electrical safety, prevention of interference, network compatibility and network interoperability.

 
Need help or have a question? +852 3008 2099
 

Need help or have a question?

+852 3008 2099
HK
+852 3008 2099