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

Basic Information*

1.      According to the regulations of the Indonesian Ministry of Health, all medical products manufactured and distributed in Indonesia must be registered with the AKD (License for Local 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 AKD Local Medical Product Distribution License Registration：

    a. Must already possess SS (Surat Standar) and/or IDAK (Medical Device Distributor License).

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

c. Must possess the CPAKB (Good Manufacturing Practice Certificate) and/or CDAKB (Good Distribution Practice Certificate).

 

4.      The AKD Local Medical Product Distribution License is valid for 5 years and can be renewed.

 

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

Processing Time & Required Documents

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

 

Risk Level

Processing Time

1A (Low Risk)

30 Working Days

2B (Low-Medium Risk)

40 Working Days

2C (Medium-High Risk)

40 Working Days

3D (High Risk)

50 Working Days


Required Documents :

 

No

AKD 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

Factory Standard Certificate (Activated)*

v

v

v

v

5

Medical Device Distributor License (IDAK)**

v

v

v

v

6

AKD Registration Application Form

v

v

v

v

7

Manufacturer Authorization Letter (Notarized in Indonesia)

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

CPAKB Certificate*

v

v

v

v

 

CDAKB Certificate**

    

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:

    *CPAKB (Certificate of Good Manufacturing Practice for Medical Devices) is required for local manufacturers.

    **CDAKB (Certificate of Good Distribution Practice for Medical Devices) is required for distributors.

 

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