To tackle the shortage of surgical masks, new factories and production lines are being set up or re-activated. The Hong Kong Government has launched the Local Mask Production Subsidy Scheme.
To be eligible for a subsidy from the Government, a production line must satisfy a number of stringent conditions, including having a clean room, having production machinery and raw materials which can produce at least 500,000 masks every month. The masks have to meet at least the ASTM Level 1 standard, and the factory has to be certified to ISO 13485.
Adopting ISO 13485 (Medical devices - Quality management systems - Requirements for regulatory purposes) provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. BSI’s broad portfolio of solutions to assist organizations become more resilient include best practices information through our standards subscription, training, assessment and certification.
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BSI supports manufacturers with conformity assessments and market surveillance procedures within the context of COVID-19
As a Notified Body for the PPE Regulation, BSI is committed to supporting the European Commission's recommendation to ensure that adequate protection is swiftly made available to those who need it most.
Our experts are on hand to discuss the options available to clients and other manufacturers and to ensure compliant products can be placed on the market as quickly as possible so that medical professionals and first responders have access to the equipment they urgently need.
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