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AKL Registration for Imported Medical Product Distribution License
According to the regulations of the Indonesian Ministry of Health, all imported and distributed medical products in Indonesia must be registered with the AKL (License for Imported Medical Product Distribution).
Basic Informations

1.      According to the regulations of the Indonesian Ministry of Health, all imported and distributed medical products in Indonesia must be registered with the AKL (License for Imported Medical Product Distribution).

2.      In Indonesia, medical products are classified into four risk levels based on their usage risks:

Risk Level

Examples

1A (Low Risk)

Dental floss, ice packs, surgical instruments, surgical gloves, oxygen masks, cholesterol testers, uric acid testers

2B (Low-Medium Risk)

Steam sterilizers, pulse oximeters, suction catheters, pregnancy test kits (self-test kits)

2C (Medium-High Risk)

ECG monitors, X-ray machines, blood glucose meters

3D (High Risk)

Heart stents, pacemakers, HIV test reagents

 

3.      The following conditions must be met to apply for the AKL Imported Medical Product Distribution License:

    a. Must already possess the IDAK (Medical Device Distributor License).

    b. Must have registered an E-report (electronic reporting) account.

    c. Must possess the CDAKB (Good Distribution Practice License for Medical Devices).

 

4.      The validity period of the license varies depending on the import model:

    a. For pure imported medical product distribution licenses, the validity is 5 years. If product specifications remain unchanged, the license can be renewed multiple times.

    b. For OEM medical product distribution licenses, the validity is 3 years and can be renewed once.

 

5.      If a company does not obtain the AKL, it cannot legally import or sell medical products in Indonesia and may face penalties such as fines.

Processing Time & Required Documents

Processing Time :
Processing time varies, based on the medical products usage risks: 

Risk Level

Processing Time

1A (Low Risk)

35 Working Days

2B (Low-Medium Risk)

50 Working Days

2C (Medium-High Risk)

50 Working Days

3D (High Risk)

60 Working Days

Required Documents :

No

AKL Required Documents

Risk Level

1A

(Low Risk)

2B

(Low-Medium Risk)

2C

(Medium-High Risk)

3D

(High Risk)

1

Company Information and Documents

v

v

v

v

2

Company Director’s Information (mobile number and email)

v

v

v

v

3

Company Supporting Documents (letterhead, stamp, email address, landline number starting with 021)

v

v

v

v

4

Medical Device Distributor License (IDAK)

v

v

v

v

5

AKL Registration Application Form

v

v

v

v

6

Manufacturer Authorization Letter (Apostille/Hague Authentication)

v

v

v

v

7

Certificate of Free Sale (CFS)

v

v

v

v

8

Factory Documents (e.g., ISO 9001 for Class 1A / ISO 13485 / CE Certificate, if applicable)

v

v

v

v

9

CDAKB Certificate

v

v

v

v

10

Product Description (including product photos and instructions for use)

v

v

v

v

11

Declaration of Conformity (DOC)

v

v

v

v

12

Trademark Patent Declaration / Willingness to Provide Agency Declaration / Trademark Certificate

v

v

v

v

13

Document Authenticity Declaration

v

v

v

v

14

Integrity Pact

v

v

v

v

15

List of Raw Materials

v

v

v

v

16

Material Safety Data Sheet (MSDS)

v

v

v

v

17

Process Flow Chart

v

v

v

v

18

Finished Product Specifications

v

v

v

v

19

Validation Report (for sterile products)

v

v

v

v

20

Software Validation Test Results (if applicable)

v

v

v

v

21

Preclinical Research

–

–

–

v

22

Clinical Evidence

–

–

v

v

23

Disease-Free Certificate for Devices Containing Biological Materials

–

–

–

v

24

Risk Analysis and Results

–

v

v

v

25

Certificate of Analysis (COA) for Raw Materials

–

–

–

v

26

Packaging Specifications (for IVD products)

v

v

v

v

27

Analytical Report or Clinical Test Report for IVD Reagents (specificity, sensitivity, stability)

v

v

v

v

28

Medical Device Test Results or Clinical & Safety Test Results (IEC, COA of finished products, QC Pass/Inspection Report)

v

v

v

v

29

Packaging and Labeling (in Indonesian/English)

v

v

v

v

30

Markings/Symbols on Tools and Packaging

v

v

v

v

31

Instructions for Use (IFU) (in Indonesian and English)

v

v

v

v

32

Product Batch Number Explanation

v

v

v

v

33

Type/Size/Accessories List (include supporting materials if applicable)

v

v

v

v

34

Supporting Materials (if claimed)

v

v

v

v

35

Documents Related to SOPs (Return, Recall, Customer Complaint)

v

v

v

v

*Note: The specific information required is adjusted according to product specifications and functions.
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