Singapore’s Health Sciences Authority (HSA) included secondary assembly activity guidelines in its medical device Technical Specification 01 (TS-01) in early July 2010. Manufacturers that make use of secondary assembly must meet new regulations by August 2011. HSA defines secondary assembly activity as “the process of repackaging a medical device from its original packaging into another packaging, without breach of the primary package, before the medical device is supplied.” The guidelines are to maintain the quality, safety and integrity of medical devices.
If a secondary assembler is necessary, the secondary assembly organization needs to meet one of two certification requirements. In the first case, the secondary assembler can abide by regulations if it is ISO 13485 certified. In the second case, the secondary assembler can meet regulations by being Good Distribution Practice for Medical Devices (GDPMDS) (including secondary assembly) certified and making no alterations to the labels, expiration dates, or batch/lot numbers. As an exception in this case, labels can have a new quantity number.
The update includes details regarding the facility conditions, assembly documents, packaging materials, labeling, assembly equipment, and quality control. Medical devices that need to follow these guidelines include active implantable devices, anaesthetic and respiratory devices, dental devices, diagnostic and therapeutic radiation devices, electro mechanical medical devices, hospital hardware, in vitro diagnostic devices, non-active implantable devices, ophthalmic and optical devices, reusable instruments, single-use devices, and technical aids for disabled persons.