1.      The Good Manufacturing Practice for Medical Devices (CPAKB) is a guideline for medical device manufacturing activities and quality assurance. Its purpose is to ensure that medical devices are consistently produced in accordance with established requirements and are suitable for their intended use. CPAKB is equivalent to ISO.

2.      The CPAKB certificate is one of the mandatory requirements for medical device manufacturers to register for a local medical device distribution license (AKD). In other words, a company must obtain the AKD distribution license before it can carry out distribution activities.

3.      If the company does not have ISO 13485 certification, the relevant authority will conduct an on-site audit, which includes a review of documentation, buildings, and the manufacturing process. The factory must be able to demonstrate trial production to the auditors during the inspection.

4.      CPAKB Audit Requirements by Relevant Authorities

   Note:

If a factory manufactures products of different risk classes, the audit will be conducted according to the highest risk class of the products.

5.      The main requirements for CPAKB certification include:

–        The company’s business scope must correspond to the type of medical devices it intends to manufacture.

–        Possess an active OSS (Online Single Submission) account.

–        Hold an active Verified Statement Letter (SS Terverifikasi).

–        Have buildings and facilities that comply with CPAKB standards.

–        Possess a relevant ISO 13485 certificate covering manufacturing activities (if available).

–        The Technical Person in Charge (PJT) must be employed full-time and have completed CPAKB training.

–        Have an e-Report account. For new factories (that have not started production): must register on the e-Report system. For existing factories (already producing medical devices): must have submitted reports through the e-Report system.

6.      The CPAKB certificate is valid for 5 years and can be renewed. (The renewal process is the same as the initial registration process)

7.      The submission for CPAKB certification will refer to the business classification code (KBLI) that corresponds to the scope of manufacturing activities for the medical devices to be registered.