Procedure and Timeline of Obtaining Medical Devices Distributor License (“IPAK”)

In accordance to Article 12 Ministry of Health Regulation No. 1911 of 2010 concerning Distribution of Medical Devices (“MoHR 1911/2010”),
general provisions to obtain IPAK be consisted of the following requirements:

a. Applicant shall be a legal entity and has obtained trading business license;
b. Have a dedicated full-time Technical Person-In-Charge with relevant academical background;
c. Have facilities and infrastructure in the worm of administrative office and warehouse,
d. Have its own workshop or liaise with another company in conducting after-sale service; and
e. Fulfill Medical Devices Good Distribution Practice (CDAKB)

No. Phase Remarks Requirements Timeline

1 Account Applicant obtains User ID and

Registration Password through Ministry of
Health’s online system
http://www.regalkes.depkes.go.id
2. Recommendation Applicant submit a written form
(stipulated in Appendix of Ministry
of Health Regulation No. 1191 of
2010) to Head of Provincial Health
Office
1 Day
The written form shall be filled out with the
following informations:
a. Name, domicile, and phone number of
applicant;
b. Name, domicile, and phone number of
Tentative
Company;
c. Address and phone Number of warehouse;
d. Address and phone number of workshop;
e. Notarial Deed and MOLHR Decree of
Company’s Establishment;

Head of Provincial Health Office
coordinates with Head of District
Health Office to form an Inspection
Team
Inspection Team conducts inspection
and issues Investigation Report to
Head of Provincial Health Office
Head of Provincial Health Office
forwards the investigation report
Directorate General issues
3 Pre-Registration Applicant uploads required
documents through online system
f. Number of Tax ID;
g. Number of Business License;
h. List of Board of Directors and Board of
Commissioners of Company;
i. Name, academic certificate, employment
agreement as Technical PIC, and other
supporting certification of the Technical
PIC;
j. Name, academic certificate, and
supporting certification of Technical
Officer;
k. Attachment of domicile location map and
building blue-print; and
l. List of medical device that will be
distributed
At the latest 12 Working
Days since submission date
of written form
At the latest 12 Working
Days since the formation
date of the team
At the latest 6 Working
Days since submission date
of investigation report
At the latest 30 Working
Days since investation
report is received
a. Investigation report issued by Head of
Provincial Health Office;
Tentative
b. Recommendation letter issued by Head of
Provincial Health Office;
c. Notarial Deed and MOLHR Decree of
Company’s Establishment;
d. Trading Business License from OSS
system;
e. Business Identification Number from OSS
system;
f. Business Location License;
g. Location Map of Company, which has
been legalized by Provincial Health Office;
h. Building blue-print, which has been
legalized by Provincial Health Office;
i. Lease agreement with building
management, Land and Building Tax
payment (PBB), and building construction
license (IMB);
j. Scanned copy of Resident Identity Card of
local Director/Commissioner; for foreign
Director/Commissioner, provide scanned
copy of temporary/permanent Staying
Permit;
k. Scanned copy of Resident Identity Card of
Technical Person-In-Charge;
l. Scanned copy of Academic Certificate of
Technical Person-In-Charge;
m. Statement Letter from Technical PIC to be
a dedicated PIC in Company;
n. Employment agreement between Technical
PIC and Company, which has been
legalized by Notary;
o. Organizational structure of the Company;
p. Job description of any role in
organizational structure;
 q. List of medical devices;
r. Brochure or catalogue of medical devices
(if any);
s. List of facilities and insfrastructure of the
warehouse; and
t. Administrative completion, i.e: Purchase
Order, Invoices, Receipt and Stock Card
Verification by evaluator.

Applicant will obtain Pre- 7 Working Days

Registration Acceptance Letter and
pay registration fee
4 Registration Applicant upload payment receipt, a. All hard copy of documents’ requirements;
submit the documentation b. Payment receipt; and
requirements above (hard copy) and c. Data conformity statement letter
data conformity statement letter.
Final evaluation

If approved, Directorate General will 45 Days

issue the Medical Devices
Distributor License (IPAK)