Singapore HSA Fine-tuning Good Distribution Practice for Medical Devices
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), is planning a new good distribution practice standard for medical devices that requires licensure of companies importing and supplying devices in the country.
The Singapore Standard for Good Distribution Practice for Medical devices, or SS GDPMDS, is based on specifications listed in the HSA document Good Distribution Practice for Medical Devices in Singapore—Requirements (HSA GDPMDS TS-01, R2.1), which sets the mandatory technical standard for licensing device importers, distributors and wholesalers.
Medical device distributors and importers have been required to obtain licensing in Singapore since 2010; by updating licensing requirements under SS GDPMDS, the HSA intends to “ensure the quality of medical devices are properly stored, transported and handled throughout the distribution process,” according to an email notice from the agency.
A draft of the SS GDPMDS will be made available for industry comment in Q2 2016; until the new standard is implemented, importers and distributors in Singapore should continue to ensure compliance with the current HSA GDPMDS TS-01, R2.1.
Companies engaged in medical device distribution in neighboring Southeast Asian countries should bear in mind that Singaporean regulators are playing a leading role in the Association of Southeast Asian Nations (ASEAN) Medical Device Directive, an effort to eventually harmonize medical device regulations across the region. So other Southeast Asian regulators will likely establish distribution requirements identical or highly similar to the SS GDPMDS.