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

Llewellyn and Partners Company Limited

Get ready for digitalisation &amp; standards compliance. Guiding you on standards, data strategies, and technology solutions for a greener future. Consultancy Services: Standardisation, digitalisation, information management and smart city solutions Standard-compliant smart built asset platform for construction and real estate industry ISO certification 

Consultancy

Nemko Hong Kong Limited

 	 Nemko&nbsp; offers NRTL approval for market access to the North American countries. 	 Nemko NRTL C mark certification and&nbsp;FCC/TCB service&nbsp;allow you to&nbsp;market your products in USA and Canada.&nbsp;  

NRTL Approval

Intertek Testing Services Hong Kong Limited

The requirement for toy testing become increasingly stringent with each day that passes. Many countries have established their own safety regulations for toys and you must ensure that your products comply with relevant standards before your goods can be sold in these locations. Manufacturers have been held liable for injuries and fatalities resulting from design flaws, use of unsuitable materials and substandard production.  As the largest players in toys, games and premium testing industry with over 1,000 laboratories and offices in over 100 countries, Intertek can help safeguard its clients - providing product safety testing, certification, inspection, evaluation and quality assurance services including:  Smart Toys TestingToys Testing for the Japan MarketPet Product Testing ServicesSafety AssessmentDesign Hazard AnalysisPre-shipment InspectionCPSIA Testing (Consumer Product Safety Improvement Act )ASTM F963 Toys Testing StandardCPSC Regulatory TestingNew EU Toys Safety Directive Compliance TestAustralian Toys Testing Standard AS/ NZS ISO 8124EC Type ExaminationGB Toys Testing StandardGSO Conformity Tracking Symbol is Now EffectiveGCC Product CertificationKC Mark Certification

Toy Testing

Sgurr Energy

 	 Global leading engineering and technical consultancy services &nbsp;for renewable energy: onshore/offshore wind, solar, hydro, wave and tidal, biomass. 	 Certificated to ISO 9001, ISO 14001, OHSAS 18001, ISO 17025.  

Engineering and Technical Consultancy for Renewable Energy

Qingdao CISO Consulting Int'l Co Ltd

  Economic information consulting services, quality system certification consultative information; corporate image planning, graphics, images, product design, production services; exhibition services, exhibition-related decoration, decoration, construction; building equipment installation; design, production, publishing domestic ads business; software development.  

Solutions

China Council For Promotion Of International Trade Yangjiang Committee

 International Exhibition Service  	 Through liaison with the General Conference, the provincial capital and overseas institutions, we organize enterprises in our city to organize (participate in) trade fairs (Bo) exhibitions and domestic foreign-related exhibitions abroad. The main (successive) organizes the city&#39;s foreign-related exhibitions (distribution) meetings to show me City&#39;s famous products. Contact and guide Yangjiang Regional Exhibition Industry Association&#39;s business work.   Certificate Authentication Service  	 Issuing the Certificate of Origin of Export Goods of the City; 	 International commodity certification for foreign-related trade documents (such as commercial invoices, customs declarations, bills of lading, packing lists, etc.) and irresistible proof of labor; 	 Consulate certification business for foreign-related economic and trade documents; 	 Representative of the temporary import and export cargo documents (ATA).   International Liaison Service  	 Invite and receive visits from foreign and Hong Kong, Macao, and Taiwanese industrial and commercial circles and delegations; carry out the development of Yangjiang City and other countries (regions) and Hong Kong, Macao and Taiwan regions, business and industry circles, business associations and other economic and trade organizations and related international economic and trade organizations. Liaison work, establish bilateral relations, maintain close contact, and promote exchange and cooperation between Yangjiang&#39;s foreign trade and international cooperation.   Overseas inspection services  	 Organize the delegation of the city to go abroad to visit and carry out economic and trade and technological exchanges and cooperation.   Account Service  	 Organize companies to participate in the international business matchmaking conference organized by China Council for the Promotion of International Trade (CCPIT) and the Provincial Council for the Promotion of International Trade, international trade fairs, training courses for enterprise personnel, etc.; organize business matchmaking sessions and training courses in the city according to the needs of the city&#39;s enterprises. .   International Commercial Law Service  	 Assisting in contacting related organizations to provide enterprises with trade friction response, legal risk prevention, international commercial disputes agency, commercial mediation, commercial arbitration, maritime arbitration, legal counseling, legal training, intellectual property agency and protection, chamber of commerce urging compliance, overseas business accounts recovery Income, average adjustment and other services.  

My Sourcing