Intertek Testing Services Hong Kong Limited

Intertek conducts and manages electrical safety testing to ANSI/UL, CSA, NFPA, IEC, EN and other standards, EMC testing to local or global requirements, benchmarking and performance testing for R&amp;D or competitive differentiation, environmental compliance to ENERGY STAR®, RoHS, or ErP Directive (formerly EuP) requirements, and also offer turnkey certification management for you.  We provide the ETL Mark, WH Mark and NOM in North America; the S, CE, GS, ASTA and BEAB Marks for Europe; and the CCC Mark in China, among others.  ETL Mark - indicates that the product has met the minimum requirements of prescribed product safety standards and the manufacturer's production site conforms to a range of compliance measures in North America.GS Mark - is a licensed mark of the German government and may only be issued by an accredited product safety testing and certification agency.CB Certificate - offers manufacturers a simplified way of obtaining multiple national safety certifications for their products - providing entry into over 40 countries.CE Mark - indicates that the requirements of all necessary Directives have been met prior to it entering the EU.G Mark - is a mandatory requirement for Low Voltage Electrical products being exported to the countries under the Gulf Standardization Organization (GSO), as defined within the Low Voltage Technical Regulation, BD142004-01.ASTA Safety Mark - indicates that the product has been independently tested to comply with the relevant clauses of the applicable standards, with a high profile in Asia and the Middle East and are often specified by major end-users.CCC Mark - stands for China Compulsory Certification requiring manufacturers in over 132 product categories to obtain the Mark before exporting to or selling in the China market.UKCA Mark - is a new United Kingdom (UK) product mark that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland) following the UK’s exit from the European Union (EU).

Certification Marks

The Hong Kong Standards And Testing Centre Ltd (STC)

Medical device regulations are constantly changing and evolving to better safeguard the health and safety of the public. However these regular changes may impact manufacturers with regards to their product requirements and registrations with local and overseas regulators.   At STC, our team of knowledgeable experts are up-to-date with the latest regulatory requirements in key markets to ensure that compliance is met and support medical device manufacturers in gaining market entry quickly.  Key Market Support: Australia(DOH)Brazil(MOH)Canada(HC)China(CFDA)Europe(CE Notified Body MDD / MDR)India(MOH)Japan(MHLW)Korea(MFDS)Malaysia(MOH)Singapore(HSA)Taiwan(TFDA)United States(FDA)Our Medical Device Product Classification &amp; Regulatory Support services include: Document Preparation for ISO13485 Certification (Gap Analysis)Medical Grade Components SourcingTechnical File / Dossier CompilingCollateral, Particular Harmonized &amp; Industrial Standards TestingTest Equipment Setup for Performance TestingBiological Testing according to GLP RequirementsSubmission of Technical File to RegulatorsRepresentation by Local RepresentativesLicense Holding &amp; Risk ManagementOn-site Support during Regulator InspectionsQMS/QSR support on CFR820, ISO13485, Canada MDR, Korea GMP, Brazil GMP and Japan Ordinance 169Electrical Testing ISO 17025CB SchemeNRTL Program. Biological Testing(ISO 10993) Interactions with blood(ISO 10993-4)Vitro Cytotoxicity(ISO 10993-5)Local Effects after Implantation(ISO 10993-6)Ethylene oxide sterilization residuals(ISO 10993-7)Irritation(ISO 10993-10)Skin Sensitization(ISO 10993-10)Systemic Toxicity(ISO 10993-11)LUCIDEON Medical Device Services As part of our commitment to offering the most extensive services to our customers, STC is working in collaboration with LUCIDEON to provide a greater range of services including Medical Device Consultancy, Materials Developments and Technology Innovations.If you have any further question, please feel free contact us or visit our website: https://www.stc.group/en/contactTo know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact.  

Medical Devices Testing

Lion Consulting Limited

Assisting to enter into China and Foreign Market Services

China and Foreign Market Entry Services

Sovereign Trust (Hong Kong) Ltd

Comprehensive services to assist through each stage of China market entry.1. Market research & Assessment2. Corporate formation (WFOES and JVs)3. Accounting Services4. Third party services

China Entry Services

Precision Eyewear Laboratory (PEL)

 We specialize in the certification of optical products and personal protective equipment for professional use. We were founded to guarantee support to the industries of the optical sector by issuing appropriate test reports, allowing them to examine products and implement production processes in accordance with European directives and international standards. Our testing and assessment capabilities are performed to worldwide standards, while our international accreditation status and recognition agreements with certification bodies in international markets enable us to facilitate conformity assessments and global market entry for our customers. 
 
  Obtained accreditation from CNAS (China National Accreditation Service for Conformity Assessment) in 2005. 
  Our reports are widely recognized. 
  Scope of accreditation (ISO, GB, EN, ASTM, AS/NZS and ANSI): ophthalmic optics, personal eye protection devices, sunglasses, ophthalmic lenses, nickel releases, spectacle frames for children, copper-accelerated, acetic acid-salt spray testing (CASS test), natural salt spray test and weathering test. 
 

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