The branch of a health equipment distributor is a business unit of a Health Equipment Distributor that has obtained a Certificate of Good Distribution Practice for Medical Devices to carry out a series of activities involving the distribution or delivery of medical devices. In establishing a branch office for a health equipment distributor, the business entity must meet several document requirements similar to those needed for the central office. These documents are necessary to enable the branch to effectively conduct the distribution or delivery of medical devices. Each branch operates under the auspices of the Health Equipment Distributor, facilitating these activities in the province where the branch is located. Distributors and their branches can distribute medical devices according to approved product categories, considering the facilities and human resources available. Regulations concerning health equipment distributor branches are governed by Minister of Health Regulation No. 14 of 2021.
Health equipment distributor branches must meet the following general requirements:
- The business entity must be a legal entity, such as a limited liability company (PT) or cooperative.
- Provide proof of payment for Non-Tax State Revenue (PNBP).
- Hold a central distribution license for medical devices.
- Possess a Certificate of Good Distribution Practice for Medical Devices (CDAKB) from the central authority.
- Provide data on the technical responsible person.
- Submit a statement of readiness to comply with CDAKB standards.
- Fulfill the requirement duration within one year from the approval of the application on the Online Single Submission (OSS) platform.
Therefore, a health equipment distributor branch requires a Distribution License for Medical Devices (IDAK) from the central authority and a branch CDAKB standard certificate from the central authority.
In addition to the general requirements, health equipment distributor branches must also meet specific requirements, including:
- The technical responsible person must have a CDAKB training certificate.
- Develop an operational business plan, including a list of product types to be distributed and the storage facilities available.
- Provide technicians and workshops (specifically for the distribution of electromedical and/or in vitro diagnostic instruments).
- Obtain a permit for the use of nuclear energy from the Nuclear Energy Regulatory Agency (BAPETEN) (specifically for the distribution of electromedical radiation devices).
References:
https://peraturan.bpk.go.id/Details/203315/permenkes-no-14-tahun-2021
