CDAKB, also known as GDPMD (Good Distribution Practice for Medical Device), is an essential certificate for medical device distribution in Indonesia. It regulates essential standards and requirements for organizations involved in medical device distribution, ensuring compliance with medical device regulations in Indonesia.
CDAKB is a certificate for the sustainability of medical device distribution in Indonesia, where CDAKB is known as GDPMD (Good Distribution Practice for Medical Device) which provides guidance for medical device distribution organizations including ordering, storage, transportation and distribution activities etc. CDAKB establishes quality management system requirements that must be established, implemented and maintained by a company in carrying out activities in the medical device supply chain to comply with Indonesian medical device regulatory requirements.
CDAKB specifies the quality management system requirements that a company must establish, implement, and maintain in carrying out activities in the medical device supply chain to comply with medical device regulatory requirements in Indonesia.
There are 13 clauses that a company must meet to obtain CDAKB, we will assist you, organize and strategize an effective management system and obtain a CDAKB certificate.
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We consist of professionals with backgrounds from multinational medical device manufacturers who specialize in product registration for local and imported products. We at PT Deray Global Utama are dedicated to helping clients navigate the medical device registration system efficiently with high regulatory compliance.
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