Home » Singapore Draft Guidance: Audit Suppliers to Check QMS Compliance
Singapore Draft Guidance: Audit Suppliers to Check QMS Compliance
Manufacturers of lower-risk Class A devices should conduct regular reviews of their quality processes and those of their suppliers to ensure compliance with licensing and/or regulatory requirements, according to new draft guidance from Singapore’s Health Sciences Authority (HSA). Companies should document the outcome of the review, any observations made and corrective actions, the guidance states. It specifies quality requirements for the import and wholesale dealing of low-risk devices.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor
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