What CDAKB is

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.

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.

Who is required to hold CDAKB

• Local medical device distributors
• Local Authorized Representatives holding the Izin Edar on behalf of a foreign manufacturer
• Medical device importers
• Regional distribution branches, depending on the company's operational structure

What CDAKB certification covers

Broadly, CDAKB coverage includes areas such as:

• Distribution quality management systems
• Resource management and responsible personnel
• Storage and warehousing standards
• Product handling and shipping procedures
• Traceability and recall systems
• Documentation and record keeping
• Customer complaint handling
• Internal audits and management review

What changed in 2026

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.

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.

The process for obtaining CDAKB certification

1. Confirm your NIB and medical device distribution business license are active
2. Prepare quality system documentation and standard operating procedures
3. Ensure storage facilities meet technical requirements
4. Submit the certification application through the Ministry of Health's designated system
5. Go through the facility and documentation audit
6. Receive the certificate and maintain compliance through annual internal audits

Mistakes we see often

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.

Conclusion

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.

If your company is preparing for or renewing CDAKB certification, we can help assess your readiness. Reach us at info@derayglobalutama.com.