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Review of regulatory management on standards and specifications for veterinary medical devices in Korea
2017
Kang, K.M., Animal and Quarantine Agency, Gimcheon, Republic of Korea | Kim, T.W., Korea Testing Certification, Gunpo, Republic of Korea | Kwon, O.R., Korea Testing Certification, Gunpo, Republic of Korea | Park, H.J., Animal and Quarantine Agency, Gimcheon, Republic of Korea | Cho, S.M., Animal and Quarantine Agency, Gimcheon, Republic of Korea | Kim, C.H., Animal and Quarantine Agency, Gimcheon, Republic of Korea | Lee, M.H., Animal and Quarantine Agency, Gimcheon, Republic of Korea | Moon, J.S., Animal and Quarantine Agency, Gimcheon, Republic of Korea
Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.
اظهر المزيد [+] اقل [-]An overview of research and industry connectivity for EBN
2018
Anun | Aini Ideris | Rosini | Ramlan M. | Jalila Abu
As of 2016, a total of 38 research projects have been undertaken, with the involvement of 38 principal researchers and 266 co-researchers from various Malaysian universities, research institutes and government agencies, in collaboration with industry partners, to help solve some of the issues faced by EBN industry. In the early stage, research areas were focused onfundamental works which are important to provide the scientific basis for some of the claims made by producers, assisting in issues raised by ranchers and industry, and to gather new knowledge in swiftlet and EBN. The researchers worked mainly based on the problems faced by the industry. Besides publications in journals, proceedings and books, more than 30 Masters, PhDs and technical experts have been trained under these projects. In addition, several patents have been filed, social innovations and ideas have been shared with the community and industry. A few products are ready to go to the next level for commercialisation. Industry partners are involved in many of these stepsand outputs. Some of the issues faced by the industry have been partially solved and are in the process of refinement. The engagement with the industry will be further strengthened by getting more industry partners to be involved in the relevantprojects specific to problems faced by the industry, for the benefits of EBN industry and nation’s wealth creation.
اظهر المزيد [+] اقل [-]Awareness of operators on the requirements and procedures for animal quarantine and the distribution of temporary animal quarantine stations in Peninsular Malaysia
2016
Ummi Noorhakimah Abdullah | Latiffah Hassan | Ong, Bee Lee
Temporary quarantine stations (TQS) are transitory premises that havebeen approved to facilitate the quarantine of imported live animals in Malaysia. These stations must abide to the standard operating procedures (SOP) for animal quarantine as outlined by the veterinaryauthority in Malaysia. However, the level of awareness for the quarantine procedures among the TQS operators and managers has not been assessed. This study was conducted to describe thedistribution of the TQS in 2012-2013 and the level of awareness among its operators on the quarantine procedures and the fundamental requirements for quarantine establishments. Eight TQS from 25 wereselected and operators or managers were interviewed using a questionnaire and the facility was visited. The study found thatmajority (82.5%) of the TQS operators were aware of the quarantine procedures but the auditors from the veterinary authorityrevealed vice versa.
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