In Indonesia, the Good Method for the Distribution of Medical Devices, locally known as the Cara Distribusi Alat Kesahatan yang Baik (CDAKB), is a set of guidelines used in a series of distribution and quality control activities aimed at ensuring that the distributed medical device products meet the requirements for their intended use.
Good Distribution Practices (GDP) for medical devices in Indonesia are governed by the Indonesian National Agency of Drugs and Food Control under the Ministry of Health (MoH). The purpose of GDP for medical devices is to ensure that the devices are distributed in a manner that protects their quality, safety, and efficacy.
In 2014, the Indonesian government introduced the CDAKB with regard to obtaining Medical Device Distribution License (MDDL), also known as the Izin Distribusi Alat Kesehatan (IDAK); IDAK is, in fact, the new name for Izin Penyalur Alat Kesehatan (IPAK) and Sertifikat Distribusi Alat Kesehatan (SDAK). IDAK carries out activities such as distribution of medical devices in compliance with the provisions of laws and regulations. As per Regulation No.1191/Menkes/Per/VIII, the distribution of medical devices is in accordance with the CDAKB guidelines, as the distribution of medical devices can only be conducted by companies having an IDAK license.
In 2020, the CDAKB guidelines were made mandatory; and all Medical Device Distributors, since then, have been required to submit all the CDAKB applications online.
What are the CDAKB Requirements?
For the application or renewal of an IDAK License, the Indonesian medical device distributor must be compliant with the CDAKB requirements. The following are the key requirements for the GDP of medical devices in Indonesia:
- Quality Management System: IDAK and its branches must have a structural configuration in compliance with the requirements, with a company chart and documents, to implement and maintain a quality document system and maintain efficacy related to the CDAKB.
- Resource Management: Personnel involved in the distribution of medical devices must be appropriately trained and qualified with respect to all the CDAKB laws and regulations.
- Edifices and Facilities: IDAK and its branches must have a facility to store medical device products. Also, IDAK and its branches that distribute medical devices, electromedical devices, and IVD must have facilities for workshops with/or in cooperation with other companies or related authorized workshops. Storage space must be adequate, so that product quality is not compromised in a cramped space.
- Equipment: IDAK and its branches can only circulate products that are permitted to be distributed. Products that have expired should be listed separately. IDAK and its branches must also ensure the necessary installation and testing in compliance with the manufacturer’s instructions.
- Traceability: The distribution chain must be fully traceable, allowing for the identification of the origin and distribution of medical devices. There must be current records that facilitate the traceability of the distributed products, including consumer and manufacturer name, batch or serial number, type, quantity, and distribution permit number.
- Complaint Handling: Curative actions must be taken without delay to prevent the recurrence of the complaint.
- Field Safety Corrective Action: There must be a pre-determined procedure for a product recall. If a product needs to be recalled, a recall notification must be made.
- Return of Medical Devices: Restored products caused by administrative errors can be transferred to commercial products, according to procedures. There must be a record of the transfer of product status and responsible personnel, and they should be placed in compliance with the First Expire, First Out (FEFO) system.
- Destruction of Medical Devices: Destruction is carried out for those medical devices that are produced without meeting the applicable requirements, have expired, or do not meet the requirements for use in health services Maintenance of the record of minutes of destruction must be signed by a technical in-charge.
- Illegal and Incompetent Medical Devices: Illegal and incompetent medical devices found in the distribution network must be physically separated from other products. IDAK must report the discovery of incompetent products to the authorized agency and inform the distribution permit holder.
- Internal Audit: IDAK and its branches must conduct periodic internal audits, as planned, to monitor compliance with the CDAKB.
- Management Review: The management review includes audit results, feedback from consumers, process performance, the status of Corrective and Preventive Action (CAPA), follow-up from previous management studies, changes affecting the Quality Management System (QMS), recommendations for improvement, and statutory requirements.
- Outsourcing Activity: IDAK and its branches must be able to control the activities carried out by third parties with applicable regulations. These activities must be agreed upon in a written agreement.
Overall, the implementation of GDP for medical devices in Indonesia aims at ensuring that the devices are distributed in a manner that protects their quality, safety, and efficacy and that they are used in a manner that is safe for the patient.
Are you looking forward to launching your medical device in the Indonesian market? Would you like to gain more insight into the Indonesian medical device market? Reach out to our Regulatory Expert. Stay informed. Stay Compliant.