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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:
www.cermet.it
( U.S. Food and Drug Administration)
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:
http://www.fda.gov/
ISO ( 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
:
http://www.iso.org/
TGA (
Therapeutic Goods Administration )
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 ar
e safe and in good quality
For details, please visit:
http://www.tga.gov.au/
CMDCAS ( Canadian Medical Devices Conformity Assessment System)
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:
www.hc-sc.gc.ca
T
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
EN60601-1
EN60601-2
for any instrument, apparatus, appliance, or other articles used on human body