Conformité Européenne logo.svg Conformité Européenne (European Products Quality Assurance)


  • Is the manufacturer's declaration that the product meets the requirements of the applicable EC directives and undergoes assessment procedures accordingly

  • Is a symbol of free marketability in the European Economic Area

  • The products must meet the requirement of safety, health and environment before getting into the free market

  • CE 0476 represents 93/42/EEC Medical Device Certificates in European Economic Area

  • Must provide ISO9000+ISO13485 certifications before successfully apply CE0476 (Medical Devices Directive)

  • For products which can be sold legally in the European market, it can also be sold in other Member States

For details, please visit:
 FDA LOGO( U.S. Food and Drug Administration)FDA1

  • Is a federal agency of the United States Department of Health and Human Services

  • Is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary products

  • Has the rights to request manufacturers or importers of equipment to submit technical reports on equipment

  • To ensure electromagnetic radiation emitting devices (ERED) complies with safety performance indicators

  • (510k) Ensures the safety and effectiveness of medical devices

       For details, please visit:

2012 iso logo printISO ( International Organization for Standardization )

  • ISO 9001
    Is the family of quality management systems standards
  • ISO 13485
    .Specifies requirements for a quality management system of medical devices

    .Demonstrates the quality system of the manufacturer is effectively implemented and maintained, and shall include the customer satisfaction from the medical device standard

    .Provides services related to the devices (design, development, production, installation, retailing, etc.)

    .Is prerequisite before applying CE, FDA, CMDCAS signs
  • The quality management systems standards supersedes ISO 13485 and ISO 13488

     For details, please visit
TGA logoTGA ( Therapeutic Goods Administration ) TGA AUSTRALIA mg

  • Safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods

  • Is recognized as one of the countries which follows the strictest regulations in drug management

  • Ensures therapeutic goods such as prescription medicines, vaccines, vitamin tablets, medical devices and blood products available for supply in Australia are safe

  • Ensures the use of medical goods and devices are safe and in good quality
For details, please visit:
scc popupCMDCAS ( Canadian Medical Devices Conformity Assessment System) TUVRHEINLAND ISO 13485 2003 CMDCAS mg

  • To confirm compliance with Canadian Medical Device Regulations

  • Is responsible to confirm equipment sold is safe, effective and complies with quality standard

  • Recognizes in its medical device licensing process the registration of a manufacturer's quality system by a Registrar accredited to the requirements of CMDCAS

  • Applies to the quality systems licensing provisions for Class II, III and IV medical devices must be ISO 13485 approved before getting CMDCAS certification

For details, please visit:
T香港安全標誌he Hong Kong Certification Centre (HKCC) (formerly known as The Hong Kong Safety Institute - HKSI)
Hong Kong Safety Mark License

  • Was established in 1998 in Hong Kong.
  • Bases on a strict operating system to operate
  • Has been tested to relevant local and international standards
  • Is accredited by China National Accreditation Service for Conformity Assessment (CNAS) and Hong Kong Accreditation Service (HKAS) for particular scopes of product certification service


  • for any instrument, apparatus, appliance, or other articles used on human body