Automated Antimicrobial Susceptibility Testing Market - Restraints
Challenges in automated antimicrobial susceptibility testing include stringent rules and regulations from regulatory bodies, which hinders growth of the automated antimicrobial susceptibility testing market size. For instance, in the European Union, antimicrobial susceptibility testing (AST) systems are regulated by the Directive 98/79/EC (IVD directive), which was changed in 2017 with the introduction of the Regulation 2017/746 of the European Parliament and of the Council. It requires design, development, and manufacturing to be performed under a quality system according to ISO 13485.
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