To tackle the shortage of surgical masks, some new factories and production lines are set up or re-activated. 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 in the factory, having production machinery and raw materials for producing at least 500,000 masks every month, the masks meeting at least the ASTM Level 1 standard, and the factory obtaining ISO 13485 certification.
Adopting ISO 13485 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. The services we provide include standards subscription, training, gap assessment, assessment and certification.
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We also provide product testing and certification for mask and PPE. Our services include direct testing and verification at product development stage, providing evidence you need for the CE marking of your products, to giving you a competitive edge with a BSI Kitemark. CE marking indicates that the minimum levels of quality and health & safety have been met.
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