Pharmaceutical, Medical Device &

Cosmetic
Regulatory Pathway
INDONESIA

Fully fledged healthcare business service provider with

end-to-end value chain coverage in ASEAN
Legal support
F&A process (tax payment, billing & collection)

Post Mkt
Surveillance

After sales service

Distribution

Importation/Man
ufacturing

Product
Registration

Due Diligence

Human Resources management

10 Legal entities across ASEAN

Sixmurs-HTH Vietnam Trading Co., Ltd.
Sixmurs Philippines, Inc.
Mursmedic Philippines, Inc.

Sixmurs
(Thailand) Ltd
Sixmurs Malaysia, Sdn.Bhd.
Sixmurs
Singapore, Pte. Ltd
PT Sixmurs Perdana
PT Sixmurs Indonesia Perdana
PT Mursmedic
PT Provital Perdana

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

Regulating Healthcare
Products in Indonesia
Health care
product
Pharmaceutical
BPOM Deputy 1

FS/ TM/
Quasi
drug

Cosmetic

BPOM Deputy 2

Food

BPOM Deputy 3

Medical
Device

Household
device

Ministry of Health

All products must be registered, except for Cosmetic (notified)

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BPOM
Organization
Structure

MoH Organization Structure

Directorate General of Health Service

Directorate General of Pharmaceutical &

Medical Device
Production &
distribution license
Post marketing
surveillance

10

High

Healthcare products regulatory framework

(based on risk)
7
6

6
5

Note : number is subjective, just indication of level for

purpose of comparison

2
1

Low

COSMETIC

FOOD

Overall regulatory control

FS : Food supplement
TM : Traditional medicine

MEDICAL DEVICE MD CLASS D &

CLASS A-C
DRUG
Pre-market Control
PMS Control

FS/TM/QD

QD : Quasi Drug
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Categorizing the Products

(Pharmaceutical-MD-Cosmetic)
Definition as per regulation,
which consists of :
Product benefit/ functionality
Mechanism
Ingredients (when applicable)

Claim and claim support

Note :
Dosage form may be
taken into
consideration
regulators expect to
see normal dosage
form
Combination product
may create complexity
in differentiating
products
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Definition

Drugs are medicines including biological product, which is a

material or combination of materials used to influence or probe
the physiological systems or pathological states for determination
of diagnosis, prevention, cure, rehabilitation and health
improvement and contraception for human (Head of BPOM
Regulation No. HK.03.1.23.10.1108481 year 2011 regarding
Criteria & Procedure of Drug Registration)
MD : instrument, apparatus, machine and or implant which does
not contain medication for the purpose of preventing, diagnosing,
curing and alleviating of disease, treating and recovering health
and/or forming structure and improving the functionality of the
body (Ministry of Health Regulation #1190/2010 regarding Product
License of MD & Household Device )
13

Definition

Cosmetic is material or preparation which is intended to be

used at the external part of human body (epidermis, hair, nail,
outer genital organ) or teeth or mucous membrane in the
mouth to clean, with the intention to clean, perfume, change
the appearance and /or improve body odor and or protect or
maintain body in good condition. (Ministry of Health
Regulation No. 1176/2010 regarding Cosmetic Notification)
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Drug eluting stent :

Cardiac stent which is covered by drug to
help reducing possibility of restenosis

Injected dermal filler to treat

wrinkles
Cream with Mentholatum &
Salicylic Acid to treat acne
15

Products to manage
GERD symptoms
Medical Device in
EU
Drug in USA
Drug in Indonesia

Eye drop for dry eyes

Medical Device in
EU, Sing, Mal
Drug in US
Drug in Indonesia,
Philippines,
Thailand, Vietnam
16

 It is important to know what is the category

of products your are dealing with before
being able to define the pathway (which will
define the milestone & deliverables)
Product categories may be different from
country to country, check & re-check even
we think we already know
Need to flexibly adjusting ourselves when
dealing with different categories (dont be
carried away with a certain category)
17

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

18

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

19

Adoption of ASEAN Cosmetic Directives

The party putting the product in the market is fully
responsible for its safety & quality
Focus on post marketing surveillance, only formula will
be thoroughly assessed in notification process
Relatively short lead time for notification (1-2 months)
20

Who can notify a cosmetic product in Indonesia?

Local Manufacturer

Importer
Private business (CV) /Private Limited
Company (PT) who outsource
manufacturing process to manufacturer
21

Who can distribute cosmetic in

Indonesia?
Distributor with maximum of 67% foreign share
For cosmetic retailer :100% local share
Department store with 400-2,000 m2 : maximum of 67% of
local share, special license from Ministry of Trade
Supermarket / minimarket : 100% local share
Drug store & Pharmacy: 100% local share

Foreign LE can still do marketing,

education & demand creation as long
as not selling
Government Regulation No 44 Year 2016

22

Company Account Registration

Fill in company
account
registration form in
online system

Timeline : +/- 14 working days

Submit and upload

administrative &
legal documents

Verification of
original documents
to BPOM (Manual)

Activation company
account

Evaluation Process*

23

Documents Required for Companys Account

Registration
Documents needed

Local
product

Import
Product

Contracted
product

Taxpayer Identification Number

(NPWP)

Production License

Import License (API-U)

Letter of Authorization (LoA)

Agreement between applicant

and Licensor

Business License (SIUP)

GMP Certificate

Certificate of Free Sales (CFS)

V
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Fill in the notification template

through BPOM online system
(notifkos.pom.go.id)
Submit
Issuance of Payment Order of GDC*
(automatically by online system)
Going back to beginning if additional
document is not submitted in 14 WD

Notification Process
Pay the payment order
Submit the payment receipt to counter
Issuance of Application Number (on
online system)

Additional document (14 wd)

Evaluation Process (14 WD)

Submit additional document

Issuance of Notification Number (on

online system)

* GDC depends on the category of product, refer to the

Government Regulation No.48 Year 2010

25

25

Principal issues
Termination Letter for
current Distributor

License Transfer process

Current Distributor issues No Objection
Letter for termination process

Submit to BPOM
Current Distributor submits Cancellation of Notification
Letter and Explanation for availability stock to BPOM
New Distributor applies
account registration to BPOM
New Notification letter is
issued by BPOM

14 WD

14 WD

New Distributor receives notification

from BPOM for activation of
companys account
New Distributor submits notification
application to online system
26

Transfer License
During the notification process of new application under new
Distributor, the products are still allowed to be distributed by
current Distributor until new notification letter (under new
Distributor) is issued by BPOM. However, the current
Distributor only allowed to distribute their availability stock
and cant do the importation process after terminated by the
Principal.
Notification process of Transfer License will follow the new
application pathway, included the timeline of notification
process.
27

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

28

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

29

MoH Regulation No.

1010/2008 is applied

Registered under Deputy 1

BPOM
Pharmaceutical
category

Food supplement

Non-pharmaceutical
category

Traditional medicine

OTC Products

Registered under Deputy 2

BPOM

Quasi drug

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Food supplement

Non-pharmaceutical
category

Traditional medicine

Quasi drug

Vitamin, mineral & other

products to help
maintaining health
(containing no API &
have max limit of
content)
Products with medicinal
function containing only
natural ingredients
(herbal)
Product with indirect
medicinal functionality
to soothe illness such as
ointment, balm, etc.
31

(*) Medicines with new active

substances, new additional
substances, new dosage form /
route of , or new combinations
that have not been approved in
Indonesia

New Drug and

biological product
including Similar Bio
therapeutic Product
(SBP) (*)

Pharmaceutical
Product

Copy drug

Other dosage which

contain drugs

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Registration
classification

New
Registration

Renewal

Variation Registration (Major Variation

& Minor Variation)

Timeline
Pre
registration
(40 WD)

Registration
(40,100,
150, 300
WD)

Total
timeline

33

34

40 working days: minor variation and registration of drug for export

100 working days: new registration for drug and biological product for life saving, new
registration of orphan drug, new registration for public health programs, new registration
for development drugs, new registration for essential generic copy drug, new registration
for copy drugs with stinel, major variation registration for drug with new indication or
posology
150 working days: registration of new drugs, biological products, and registration for major
variation of new indications registration / posology approved in countries that have
implemented harmonized evaluation system and in the country with well-known evaluation
system; registration of new drugs, biological products, and a major variation new
indications registration / posology approved in 3 country with well-known evaluation
system; copy drug without stinel
300 working days : registration of new drug, biological product, similar biological product, or
registration of major variation of new indications registration / posology that not include in
150 working days evaluation pathway

* For Biological product

Type
Change safety related product
information that need clinical study
data

Major Variation
Changes

Change / add Indication and / or Posology; Change

safety related product information

Change related API and / or Formula Change related API and / or Formula that need clinical
that need clinical study data
study; Change Master Cell /*Seed Bank
Change safety related product
information that no need clinical
study data

Change safety related product information

Change of product ownership

Change of registrant

Change related API

Change and / or add API manufacture; Change API

manufacturing process; Change IPC spec of API*,
Change spec of Non Pharmacopeia API, Change
product spec & shelf life*; etc.

Change related finished product

quality

Increase batch size >10x; Increase / decrease batch

size up to 10x (for sterile product); change tablets
coated material weight for gastro-resistant product,
35etc.
change qualitative and/or quantitative ingredient,

Minor Variation
Type

Changes

Change related product

information and/or labeling

Change product information; change imported product

manufacturers name; change product trade name;
change packaging dimension; add product information;
claim tightening

Change related API quality

Minor change on API manufacturing process; change

analytical method; change/add testing place*; change
self life.

Change related finished product

quality

Change product releasing party**; Increase and/or

decrease batch size (for tablet and oral liquid); Change
capsule manufacturer; change capsule size; change
product form / dimension (for tablet gastro-resistant,
slow-release tablet); change analytical method; etc.

* For Biological Product ** For imported product

36

Change of product ownership

Principal issues
Termination Letter for
current Distributor

Current Distributor issues No

Objection Letter for
termination process

Share the copy of Termination Letter and

No Objection Letter to New Distributor

New Distributor submits the Variation

registration (Major Variation) included No
Objection Letter and Current License

Evaluation
Pre-Registration: 40 WD
Registration: 100 WD

37

Document required for Change of Product

Ownership
Administrative document:
Statement letter from current product owner to transfer their
product;
Product information
Packaging design

Quality Documents:
Quality documents of API (Active Pharmaceutical Ingredients)
Quality documents of finished product
38

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

39

Regulating healthcare
products in Indonesia
Cosmetic
OTC product
Medical device

40

Legal entity establishment (PT with

max of 49% foreign share under
President Regulation #44/2016)
MD Distributor
establishment (MoH
Regulation 1191/2010)
Product registration

Only products, which

registration # is listed
in the INSW system can
be released by custom

Importation under the

name of product license
holder
41

42

Pre- requisite for application of MD Distributor product license

Five sections of license coverage :
Non-electromedical, non sterile
Non-electromedical, sterile
Electro-medical, non-radiation
Electro-medical, radiation
In vitro Diagnostics
MD manufacturer must poses IPAK for being able to distribute
its own products
Two stages :
Audit & recommendation from PTSP (One-door integrated
services)
License issuance from Ministry of Health

Medical Device in Indonesia

Adopting EU Directives via ASEAN
MD Directives

Adopting US FDA definition when

EU Directives is not applicable

Cover broader
range of
products vs.
other countries
(in general)

Any types of products (non drug)

which will be used in hospital only,
i.e. hospital furniture
43

MD Classification
Principle of classification : based on risk to patients, users &
others
Risk Class

Risk Level

Examples

Low risk

Surgical retractors / tongue

depressors

Low-moderate risk

Hypodermic Needles / suction

equipment

Moderate-high risk

Lung ventilator / bone fixation

plate

High risk

Heart valves / implantable

defibrillator
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Documents
Review
Creating draft
input and
dossier
preparation for
products
submission

Registration Process of MD
Consultation with MoH if there is any issue related
documents and/or grouping and classification of products
Submit draft input and upload dossier
according to the requirements
Evaluator Product classification
process (7 calendar days)

Not
MD

MD
GDC Payment Request Payment Process and Upload GDC
Payment Receipt to online system (14 calendar days)
Evaluation
Class I/A: 45 days
Class 2a/B: 90 days
Class 2b/C: 100 days
Class 3/D: 120 days

Identified that the

products are not
considered as
medical devices

45

Evaluation I (in Accordance with the class)

Class I/A: 45 days
Class 2a/B: 90 days
Class 2b/C: 100 days
Class 3/D: 120 days

Yes

License issued by
MoH

License Issuance
Process
(1-2 months)

No
OK

1st Additional Data Request

(30 Days)

Checking License
Number by
Distributor
No

Evaluation II Additional Data

(45 days)

Yes

Revision to MoH
( 1 month)

No
2nd Additional Data Request
(30 Days)

Evaluation III Additional Data

(45 days)

Rejection

Revised License
issued by MoH
Yes

46

License Transfer
Principal issues
Termination Letter for
current Distributor

Current Distributor issues No

Objection Letter for
termination process

Share the scan of Termination Letter and

No Objection Letter to New Distributor

New Distributor submits the new

application (full dossier) included scanned
copy of Termination Letter, No Objection
Letter and Current License

Evaluation
Class I/A: 45 days
Class 2a/B: 90 days
Class 2b/C: 100 days
Class 3/D: 120 days

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PT Sixmurs Perdana
Gading Bukit Indah Blok SB No. 21
Jakarta 14240- INDONESIA
Telp : 021-290-78-797
Fax : 021-290-78-922
info@sixmurs.com
www.sixmurs.com
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