CDAKB, Indonesia's Good Distribution Practice for medical devices, is a mandatory certification for any entity distributing medical devices in the country. Equivalent to GDP standards elsewhere, CDAKB ensures products are stored, handled, and distributed in a way that protects quality and safety through to the end user.<\/p>\n\n\n\n
This is not optional. Every distributor, including a Local Authorized Representative (LAR) acting on behalf of a foreign manufacturer, must hold it before distributing medical devices legally.<\/p>\n\n\n\n
Broadly, CDAKB coverage includes areas such as:<\/p>\n\n\n\n
With tighter integration into the OSS RBA system, several CDAKB application and renewal processes are now directly linked to business licensing data under the NIB. In addition, the annual internal audit reporting obligation is now formalized as a mandatory requirement, rather than a recommended practice. <\/p>\n\n\n\n
Another relevant change: a clearer link between CDAKB and ISO 13485, where the two certifications are now treated as complementary rather than substitutes for entities acting as both manufacturer and distributor.<\/p>\n\n\n\n
The most common one: companies assume CDAKB is issued automatically once a product's Izin Edar is approved. The two are actually separate processes. We also frequently encounter companies whose certification has lapsed because they were unaware of the annual audit obligation, and only realize it once their distribution operations are suddenly held up.<\/p>\n\n\n\n
CDAKB is not an administrative formality. It is the operational foundation for anyone distributing medical devices in Indonesia. Companies that build compliance systems from the start, rather than assembling them reactively when facing an audit, consistently deal with fewer operational disruptions.<\/p>\n\n\n\n
If your company is preparing for or renewing CDAKB certification, we can help assess your readiness. Reach us at info@derayglobalutama.com.<\/p>\n\n\n\n