Other certification
-
RCM (Regulatory Compliance Mark)Outline
The Australian Electromagnetic and Wireless Communication Mandatory Specification was incorporated into one RCM mark from 1 March 2013 under the existing Australian Electronic Conformity Marks and A-marks; RCM certification is controlled by Regulatory Compliance Mark Standards Australia.
Applied EquipmentEMC related devices, digital network interface related devices, ISNDN and Cellular / Wireless devices, analog network interface devices, etc.
Related AgencyAustralian Communications and Media Authority ([Link])
-
TGA (Therapeutic Goods Administration)Outline
TGA is an Australian pharmaceutical, medical device, genetic technology and blood products regulator, and all medicines and medical devices imported, exported and sold in Australia must be registered/marked in the Australian Pharmaceutical Database and must obtain a TGA conformity assessment certificate in advance.
Applied EquipmentMedical devices and medical carnivores
Related AgencyTherapeutic Goods Administration ([Link])
-
BSMI (Bureau of Standards, Metrology and Inspection)Outline
The Australian Electromagnetic and Wireless Communication Mandatory Specification was incorporated into one RCM mark from 1 March 2013 under the existing Australian Electronic Conformity Marks and A-marks; RCM certification is controlled by Regulatory Compliance Mark Standards Australia.
Applied EquipmentMEPS Items: Refrigerator, fluorescent lamp, stabilizer, incandescent bulb, dehumidifier, air conditioner, fluorescent lamp, etc. (14 items)
EERL Items: Built-in fluorescent lamps, vehicle refrigerators, etc. (6 items)Related AgencyBureau of Standards, Metrology and Inspection (CHQ #2285 [Link])
-
TFDA (Taiwan Food and Drug Administration)Outline
Before importing medical devices into Taiwan, TFDA (Food and Drug Administration), an affiliate of the Ministry of Health and Welfare, regulates the registration and sale of medical devices in Taiwan.
It is divided into in vitro diagnostic reagents and non-in vitro diagnostic reagents during permission screening, and is classified as first-grade, secondgrade, third-grade, and newly developed medical devices.Applied Equipment17 items of medical devices classified by function, purpose, method of use, principles, etc.
Related AgencyTaiwan Food and Drug Administration ([Link])
-
NCC (National Communications Commission)Outline
The Taiwan Communications Commission (NCC) is the Taiwan Communications Commission and for type approval of the communication terminal, the manufacturer must be certified by the NCC or the recognized certification authority (RCB).
Applied EquipmentOne of the customs clearance documents required for import clearance is the customs union of the "Eurasian Economic Community (EAEC)", consisting of Russia, Kazakhstan and Belarus, which is divided into two certifications: a new integrated technology certification system, Coc and Doc.
Related AgencyNCC(National Communications Commission [Link])
-
TR CU (Technical Regulation of Customs Union)Outline
One of the customs clearance documents required for import clearance is the customs union of the "Eurasian Economic Community (EAEC)", consisting of Russia, Kazakhstan and Belarus, which is divided into two certifications: a new integrated technology certification system, Coc and Doc.
Applied EquipmentCoC: Pressure vessels, tools, cranes, elevators, electrical appliances, etc.
Doc: Low-risk generic productsRelated AgencyTechnical Regulation of Customs Union
-
ANATEL (Agencia Nacional telecomunicacoes)Outline
ANATEL (National Telecommunications Agency) is a Brazilian Ministry of Information and Communication and enacts various laws and regulations related to telecommunication devices, and notifies the details of OCD's application for approval on its website. The items subject to compulsory certification are divided into three categories designated by ANATEL, and each item must meet technical requirements. ANATEL certification shall be finally registered with ANATEL after issuing the certificate of the designated certification authority (required ISO 9001 for Class) through product testing, and all products approved with ANATEL product shall be labeled with the ANATEL logo and certification number.
Applied Equipment- I : General telephone terminals, cables, mobile phone terminals, etc.
- II : Equipment that uses electromagnetic spectrum to send and receive signals to products not included in the as part of communications equipment (Bluetooth, WLAN)
- III : Product optical cables not included in I and II, multi-communication electronic system routers, among equipment responsible for the connection and networking between telecommunication equipment.Related AgencyAgencia Nacional telecomunicacoes ([Link])
-
INMETRO (The National Institute of Metrology, Standardization and Industrial Quality)Outline
Brazil's INMETRO certification system is largely operated by a third-party certification system and a self-conformity declaration system, and the certification system is applied differently depending on the product.
The self-conformity declaration system is generally applied to low-risk products, and for third-party certification systems, three major requirements apply: product testing, the other is factory screening, and the last is customer compound service (CCS).
The certificate must be issued by the INMETRO designated certification authority (OCP) and may be tested at the INMERO designated laboratory or at a third party laboratory designated under the INEMTRO Mutual Recognition Agreement (ILAC, IAAC).Applied Equipmenthousehold electrical equipment, information office equipment (government procurement), gas equipment (pressure regulator or hose), switches, plugs, outlets, ballast, wires and cables, LED lamps, etc.
Related AgencyThe National Institute of Metrology, Standardization and Industrial Quality([Link])
-
ANVISA (Agencia Naciona Vigilancia Sanitaria)Outline
Brazilian medical device certification is distinguished by forced and non-forced depending on the item. Brazil's medical device classification system is similar to the basic regulation of 93/42/EEC in Europe. ANVISA requires manufacturers of medical devices to comply with Brazil's Good Manufacturing Standards (GMP), and INMETRO certification is required if the product is electrically powered device. In order to import and sell medical devices in Brazil, ANVISA must undergo a medical device registration process, BRH must be required to register medical devices, and Class I, II, III, IV are divided into four categories based on product risk.
Applied EquipmentAll medical devices are subject to registration and are classified as Class I, Class II, Class III, Class IV (Brazilian Resolution RDC 185/2001)
- Class I: Products that are less likely to pose a risk to users or public hygiene require only ANVISA short-form registration
- Class II: Regular registration of ANVISA is required for products that are likely to pose a risk to users or public health
- Class III: Products that are highly likely to pose a risk to users or public hygiene require ANVISA registration
- 3-a group (Class IV): Requires ANVISA registration as an item requiring an Auto TestRelated AgencyAgencia Naciona Vigilancia Sanitaria ([Link])
-
CNC (The Comision Nacional de Comunicaciones)Outline
In Argentina, in order to sell wired and wireless communication devices such as Wi-Fi and RF devices, importers or sellers must register their products in the CNC Registry de Actividades.
Argentine communications are managed by The Comision Nacional de Comunicaciones (CNC), which has the authority to review and enforce technical standards for commercialization of telecommunications products. CNC approval is required by an Argentine legal representative and must be registered with the CNC in order to become a Certificate holder.Applied EquipmentBT Wi-fi devices, analog communications, radio frequency RF equipment, digital devices, RF devices, etc.
Related AgencyThe Comision Nacional de Comunicaciones ([Link])
-
IRAM (Instituto Argentino de Racionalización de Materiales)Outline
Argentina will not be able to export and sell products to Argentina unless it receives a certificate of conformity (S-mark) from a designated certification authority for electrical and electronic items designated as regulated according to the "Resolution 92/1998" requirements for commercialization of low-voltage electronic devices. A certificate must be issued under the name of a local importer in Argentina, and the target items are low voltage devices of 50Vac to 1000Vac or 1500Vdc or less, and parts (installation material) can be subject to 63A or less, and batteries, lamps and exercise devices are subject to regulation. Argentina enforces a compulsory certification system for electrical and electronic items designated as regulated items, and in the case of electrical safety, three different certification systems are applied at the choice of products and applicants.
Applied Equipmenthome appliances such as lamps and luminaires, air conditioners, refrigerators, dryers, home and commercial cooking appliances, switches, fuses, etc.
Related AgencyOrganismo Argentino de Acreditación ([Link])