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EUDAMED (UDI data), GDSN data registration service

EUDAMED (UDI data), GDSN data registration service

We provide UDI databases including EUDAMED and GDSN data registration services to medical device manufacturers.

The "BYRD - theplatform" provided by the German company osapiens/BYRD.health is a service that supports the registration and transmission of UDI data such as MDR, IVD-R, MDD, and IVD-D to the medical device database "EUDAMED" (European Databank On Medical Devices) operated by the European Commission. In addition to the EU, we also provide data transmission services to the US FDA/GUDID, UK NHS/Scan4Safety, China NMPA/CUDID, Taiwan (TUDID), South Korea (IMDIS), and Saudi Arabia (SAUDI-UDI). Furthermore, we are planning to support UDI data submissions for countries such as Australia, Switzerland, Canada, Brazil, and Egypt in the future. Grid Agent offers this service to medical device manufacturers in Japan and the Asia-Pacific region.

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[Blog] The Basics of Brand Protection: How to Make It an Active Strategy

[Blog] The Basics of Brand Protection: How to Make It an Active Strategy

As the number of counterfeit and imitation products increases, the importance of brand protection is becoming increasingly significant, and it has now become an essential defense for businesses.

After establishing a brand, it becomes necessary to begin efforts to maintain it. The most effective form of brand protection involves responding dynamically and multilayeredly with basic strategies, resulting in stronger measures. First, please check the protection of brand assets related to basic trademarks, copyrights, and anti-counterfeiting. *You can view the detailed content of the blog through the related links. For more information, please feel free to contact us.*

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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 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 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 uses 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 uses in limited locations (1t ≤ reported amount < 10t/year) ■ Standard Registration New chemical substances require application based on the reported amount for business purposes: - Level 1 (1t ≤ reported amount < 10t) - Level 2 (10t ≤ reported amount < 100t) - Level 3 (100t ≤ reported amount < 1000t) - Level 4 (1000t ≤ reported amount)

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