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EUDAMED (UDI data), GDSN data registration service

EUDAMED (UDI data), GDSN data registration service

Providing UDI databases to various countries, including EUDAMED, and GDSN data registration services to medical device manufacturers.

"BYRD Health" is a service that supports the registration and transmission of UDI data such as MDR, IVDR, MDD, and IVDD to the medical device database "EUDAMED" (European Database on Medical Devices) operated by the European Commission. In addition to the EU, we also provide data transmission services to US FDA/GUDID and UK NHS/Scan4Safety. We are also gradually offering support for UDI data submissions to countries such as China (NMPA/CUDID), Taiwan (TUDID), South Korea (IMDIS), and Saudi Arabia (SAUDI-UDI). GridAgent provides this service to medical device manufacturers in Japan and the Asia-Pacific region.

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『GoDaddy』

『GoDaddy』

With GoDaddy, everything from domain management to protection is seamless.

GoDaddy is an online service that supports everything from domain acquisition to website operation and security all in one place. [Features] - You can search for and register domains. - Domain privacy helps reduce information exposure. - Domain Protection prevents unauthorized actions. - DNS management allows you to control the destination of your site. - Premium DNS enhances redundancy. *For more details, please refer to the related links or feel free to contact us.

  • Company：B7
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Taiwan Existing Chemical Substance Registration Service

Taiwan Existing Chemical Substance Registration Service

Broad support for Taiwan's chemical substance regulations.

Asian Express has established a partnership with a local consulting company that directly inquires with the Taiwanese authorities, providing a variety of chemical consulting services in Taiwan swiftly. 【Service Details】 *Phase One* - From September 2015 to March 31, 2016: If the average annual quantity of an existing chemical substance manufactured or imported for the first time reaches 100 kg or more over three consecutive years, or if the maximum quantity within three years prior to application registration exceeds 100 kg, it is necessary to apply in accordance with relevant regulations. - From April 1, 2016, to the present: Existing chemical substances manufactured or imported for the first time must be applied for within six months from the date the annual quantity reaches 100 kg or more. *Phase Two from 2020* From the data of existing chemical substances already registered in Phase One, a total of 106 types of chemicals that are widely distributed domestically, have a high potential for hazardous properties, or have insufficient information are prioritized for re-registration of existing chemical substances.

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Taiwan New Chemical Substance Registration Service

Taiwan New Chemical Substance Registration Service

Broad support for Taiwan's chemical substance regulations.

Asian Express has established a partnership with a local consulting company that directly inquires with Taiwanese authorities, providing a variety of chemical consulting services in Taiwan swiftly. 【Service Details】 ■ Small Quantity Registration - New chemical substances in general (reported amount ≤ 0.1t/year) - Research and development purposes for products and manufacturing processes (reported amount ≤ 1t/year) - Polymers that do not fall under low concern polymers (reported amount ≤ 1t/year) - Intermediate use in limited locations (reported amount ≤ 1t/year) - Low concern polymers (1t < reported amount ≤ 1000t/year) ■ Simplified Registration - New chemical substances in general (0.1t ≤ reported amount < 1t/year) - Scientific research purposes (1t ≤ reported amount < 10t/year) - Research and development purposes for products and manufacturing processes (1t ≤ reported amount < 10t/year) - Polymers that do not fall under low concern polymers (1t ≤ reported amount < 10t/year) - Intermediate use in limited locations (1t ≤ reported amount < 10t/year) ■ Standard Registration New chemical substances require application based on business purposes according to the reported amount: - Class 1 (1t ≤ reported amount < 10t) - Class 2 (10t ≤ reported amount < 100t) - Class 3 (100t ≤ reported amount < 1000t) - Class 4 (reported amount ≥ 1000t)

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