1. The BAPETEN import license is a mandatory permit that importers must obtain before importing radiation medical devices. This license also ensures that the imported radiation medical devices meet BAPETEN’s safety standards. Radiation medical devices refer to equipment that emits radiation during use, such as X-rays, CT scans, etc. A single certificate can only include up to 5 product types, with an import quota for each type.

2. Benefits of obtaining the BAPETEN import license:

    a. Allows the import of radiation medical devices;

    b. Fulfills the requirements for obtaining a Medical Device Distribution License (IDAK) for radiation medical devices;

    c. Ensures safety and effectiveness in the use of radiation medical devices.

3. According to BAPETEN Regulation No. 3 of 2021, companies applying for the BAPETEN import license can be 100% foreign-owned. Indonesia implements an exclusive agency system, with business scope including 46643.

4. Technical requirements for applying for the BAPETEN import license under BAPETEN Regulation No. 3 of 2021:

    a. Possession of suitable buildings and facilities for importing radiation medical devices;

    b. Employment of a Radiation Safety Officer (PPR) who has undergone training and holds a valid SIB (Work Practice License);

    c. Employment of at least one technician.

5. Requirements for Radiation Safety Officer (PPR) and Technician:

6. BAPETEN import license warehouse regulations apply to warehouse zones and shop houses (Ruko), with the following conditions:

    a. The warehouse address must be stated in the NIB and must match the actual location, which must be within an Industrial Estate (KI or KPI);

    b. The office and warehouse can share the same address;

    c. If the office and warehouse are at different addresses, both must be listed in the NIB.

7. Equipment required when applying for the BAPETEN license includes:

    a. Surveymeter

    b. Medical apron (if applicable)

    c. TLD

    d. Radiation warning symbol

    e. Information board (if applicable)

8. Currently, the BAPETEN import license is valid for 5 years.