Indonesian

Medical Device
Landscape
Transformation
22 June 2022

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Each of us has a
crucial role in ensuring
that the next
generation is healthy,
well-educated, and
productive.

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MoH is committed to implementing health system transformation
Six pillars of health transformation
Vision
In line with the President's vision to create healthy, productive, independent and just people

Improve maternal,
Health
children health, family Accelerate improvement Healthy Movement Strengthen health system
system Improve disease control
planning and of community nutrition Culture (GERMAS) and drug & food control
outcomes
reproductive health

1 Primary Care Transformation 2 Secondary Care 3 Health System Resilience

Transformation Transformation

a b c d a b
Population Education Primary prevention Secondary Improving Increasing access Improving Strengthening
6 main prevention capacity and and quality of resilience of emergency
7 main campaigns: adding the scope of response resilience
pillars immunization, Health screening for capability of secondary health pharma and med-
14 routine
balanced nutrition, 14 leading diseases primary care care devices sector national network of lab
immunization and to based surveillance,
sports, no-smoking causing death in Developing Puskesmas Constructing hospitals Local production of
movement, all regions in additional workers for
each age target, in 171 sub-districts, in eastern areas, 14 routine vaccines, emergency response,,
sanitation, disease Indonesia stunting screening, & provision of 40 mentoring network of 6 top 10 med, top 10 table top exercise of
screening, and improving ANC for crisis preparedness.
essential med, adding priority care, med-devices by
medical compliance maternal and baby health workers in partnership with world’s volume & by value.
health. primary care t op healt hcare cent ers.

Health Talent
4 Health financing 5 6 Health Technology
Transformation Transformation Transformation
Health financing regulation with 3 Adding med students quota, local and Development and usage of technology, digitalization,
goals: accessible, sufficient, and and bio-technology in health sector.
international scholarship, easy access for
sustainable; equitable allocation; abroad medical graduates for adaptation a Information b Biotechnology
and effective-efficient utilization process. technology

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Pilar 3

Health System
Resilience
Local production of pharma
and medical devices and the
emergency response resilience

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Strategy for the resilience of pharmaceutical, medical devices, and
emergency response
2022 2023 2024 2025
Vaccines 1. Measles
3. Hep B
4. Rotavirus
2. Rubella 5. HPV 7. IPV
3. Rotavirus 6. PCV 8. JE
Production of 7 out of 14 types of antigens for the routine 4. TBC
immunization vaccines and tuberculosis program
mRNA vaccine Viral vector vaccine
Mastery of viral-vector and nucleic acid based technologies
Technology transfer through B2B, international organization, and multilateral cooperation

Pharmaceutical
Insulin
1. Candesartan 3. Amlodipine 5. Cefixime
2. Bisoprolol 4. Lansoprazole 6. Ceftriaxone
Production of 6 out of 10 highest consumption pharmaceutical
raw materials / active pharmaceutical ingredients (API)
Plasma Derivatives
EPO, Insulin, m-Ab (Albumin, IVIg, F-VIII), m-
m-Ab (Tocilizumab),
Production of biopharmaceutical and plasma derivatives (Bevacizumab), St em
HyFC-EPO
Ab (Adalimumab,
Cell Rituximab, PD-1), R-
Insulin

Medical Devices Local content (TKDN)

of medical devices
Increase purchases of 16 out of 19 top medical devices by
volume and value produced in Indonesia 1. CT Scan
2. Endoscopy
3. MRI
Production of high-tech medical devices (3 out of 19)

Emergency Response 100% registered and

Training and
Initiate cooperation trained emergency
Registered and trained emergency team cert ificat ion
team 5

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Local production of top 10 medical devices by volume and
by value
16 out of 19 top value medical devices can be produced locally, while 3 are still dependent on import

No By Volume By Value

1 Piston syringe Continuous ventilator (non invasive & invasive/ICU)

2 Intravascular administration set Cardiac monitor (including cardiotachometer and rate alarm)

3 Surgeon’s glove CT Scan / Computed tomography x-ray system

4 Intravascular catheter Endoscope and accessories

5 Gauze & wound dressing Mobile x-ray system

6 Specimen transport and storage container AC & manual hospital bed

7 Hypodermic single lumen needle MRI / Magnetic resonance diagnostic device

8 Alcohol swab Piston syringe

9 Blood specimen collection device Stationary x-ray system

Surgical mask, coverall, surgical gown, shoe cover, cap,
10 USG / Ultrasonic pulsed doppler imaging system
medical goggles / Surgical apparel

Fully dependent on import Low production capacity

Source: LKPP e-Catalogue 2019-2020

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Policy to promote the resiliency of pharmaceutical and medical
devices
Research & development
• Task force to develop R&D
ecosystem
• Facilitate technology transfer
• Facilitate clinical trial for
vaccine (especially Merah
Putih Vaccine)
• Facilitate clinical trial for
medical devices
• Facilitate the change source
of pharmaceutical raw
materials / active
pharmaceutical ingredient
(API)
Production
• Intervention through incentives
and disincentives for pharma and
medical devices industries
• Simplification of permission
process
• Facilitate testing and calibration
performance and use of medical
devices
Market protection
• Substitution of imported products:
Freezing imported products in the e-
catalog that can be produced locally
and are able to meet national
demand
• Implementation of domestic
component level / local content
(TKDN) policy: prioritizing
pharmaceutical and medical devices
product with high domestic
component level / local content
(TKDN) in the procurement of goods
and services
• Implementation of Increased Use of
Domestic Product (P3DN) program
especially in the government / public
hospitals (vertical and regional) and
private hospitals
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Regulatory
Convergence and
Harmonization

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Strengthening regulatory capacity to ensure access to affordable medical
products that are safe, of good quality and effective

Technologies, Regulatory Safety and

Standards, System Vigilance
Norms Strengthening

Decreased Reduced time Increased Decreased cost Reduced

regulatory for regulation regulatory of regulation mortality and
burden capacity morbidity

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 Regulation on Medical Device Sector
• Pre and Post Market Control

Product Research Registration/ Adverti Distribution Consumer Disposal

Production
and Development product License sment

GDP
• Manufacturer License • Product License
• Distribution License

GMP

Enforcement
Sampling Monitoring Vigilance Advertising & audit
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 Regulation on Medical Device Sector
• Indonesia Medical Device Regulation Based on Regional and
Global Practices Clinical
Performance
& Regional and multilateral cooperation
Safety
AMDD Indonesia has
ratified
Quality ASEAN
GHWP Management MEDICAL
System DEVICE
Pre-Market DIRECTIVE
(AMDD). Priotity Working Area:
WHO, APEC, IMDRF Medical Devices : Pre-
Bilateral cooperation Market, Post-Market and
QMS

Post Market

Standards
Collaboration with
Bilateral Cooperation Asia, Middle East
and Africa through Collaboration with South East Asia countries for
GHWP. medical products with one of Working Group is Medical
• USA • India • Laos • China Device and IVD.
• Australia • Iran • PNG • Turkey
• Netherland • Colombia • Qatar • Vietnam
• Brunei Darussalam • SouthKorea • Singapore • Etc (MoU on progress)
• Denmark • Cuba • Timor Leste
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Regulation on Medical Device Sector
• MD Classification HIGH RISK
D

C MODERATE
HIGH RISK

LOW
MODERATE
RISK
A
LOW RISK
Classification AMDD EU
(ASEAN MED DEV
DIRECTION)

Low risk A I
Low-Moderate risk B IIa
Risk Clasification is based on the
potency of risk that caused Moderate-High risk C IIb
High risk D III
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 Overview of Medical Device Registration

New Application

Applicant REGALKES
▪ Determine risk class of MD
▪ Submit medical device registration
application and upload the requirements
▪ PNBP (fee) payment

Fulfillment of
PB UMKU application Download
requirement in the
Yes
Ministry/Institution
EVALUATION Approved?
▪ Login with OSS-
(K/L) system Applicant
RBA username and No Medical device
password need additional data registered
▪ Submit PB UMKU
application Yes (product license)

Submit EVALUATION
additional data of additional Approved?
and
requirements data
No Rejection letter

Download

Product License Registration • Login by Regalkes username and password

✓ Renewal • Submit application renewal, variation, renewal with variation
✓ Variation REGALKES • PNBP (fee) payment
REGALKES
✓ Renewal with variation • Evaluation
• Issued product license

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 Medical Device Registration

Notification
Submitted by:

• Certain low risk medical

Manufacturer device (class A)
• SLA <<
Production License/ • Requirements <<
Standard Certificate
https://oss.go.id/

Distributor
Regular
Distribution License

• Class A in general
• Class B, C, D
• SLA>>
• Requirement >>
http://regalkes.kemkes.go.id/
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 MEDICAL DEVICE REGISTRATION Service Level Agreement (SLA) of
Indonesia Medical Device Classification MEDICAL DEVICES
New Registration
Medical devices risk Evaluation timeline
High Risk classification Medical (maximum of working days) Registration
Device
dermal filler, determines the Class Local Imported Fee
Class D breast implant, Product Product
registration IDR 1.500.000
HIGH IOL A 10 15
requirements that (±USD 105)
RISK IDR 3.000.000
has to be submitted B 20 30
(±USD 210)
to ensures the IDR 3.000.000
C 20 30
safety, quality and (±USD 210)
Class C ventilator, infusion IDR 5.000.000
set, mobile x-ray, efficacy/performanc D 30 45
(±USD 350)
MODERATE - HIGH
contact lens e of medical devices *1 USD = ± IDR 14300
RISK
Registration for renewal , variation,
or renewal with variation
Surgical apparel, Evaluation timeline
Class B (maximum of working days)
Registration Fee
electric hospital bed, Medical
LOW - MODERATE sphygmomanometer, Device Variation or
Renewal/ Renewal w/
RISK incubator Class Renewal renewal w/
Variation variation
variation
IDR 500.000 IDR 1.000.000
A 7 10
(± USD 35) (±USD 70)
IDR 1.000.000 IDR 1.500.000
B 7 10
Class A Gauze, manual (±USD 70) (±USD 105)
LOW RISK IDR 1.000.000 IDR 1.500.000
hospital bed, glove, C 7 10
(±USD 70) (±USD 105)
surgical instrument D 7 10
IDR 1.000.000 IDR 1.500.000
(±USD 70) (±USD 105)

Evaluation of additional data /information maximum 10 working days

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Low Risk except 7 working days for renewal application
 Indonesia CSDT Format

ASEAN CSDT FORMAT

(from AMDD) INDONESIA CSDT FORMAT
• Executive summary • Form A: Administration data
• Essential Principles & Evidence of • Form B: Product information
Conformity • Form C: Specification and Quality
• Device Description Assurance
• Design Verification & Validation • Form D: Labelling
• Clinical Evidence • Form E: Post Market Evaluation
• Device Labelling
• Risk Analysis
• Manufacturer Information
Indonesia Registration Forms
“The adoption of the ASEAN CSDT in Indonesia → Requirements for product license
arranged in different formats but with essentially the
same contents”
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REQUIREMENTS OF MEDICAL DEVICE REGISTRATION
FORM A
Administration
1. Production
license/Standard
Certificate
2. Distribution license
3. Letter of authorization
4. Certificate of free sale
5. Quality management
system certificate and
certificate of conformity
(ISO 13485, CE)
6. Executive summary
7. Declaration of conformity
8. Trademark patent
statement / releasing
agency
9. Statement of data
authenticity
10.Statement of integrity
FORM B
Product
Information
1. Product Description
2. Description and Features
of Medical Devices
3. Intended purpose
4. Indications
5. Instructions for use
6. Contraindications
7. Warnings
8. Precautions
9. Potential adverse effects
10. Alternative therapy
11. Material
12. Information about
manufacturer
13. Manufacturing and QC
Process
FORM C
Specification
and Quality
Assurance
1. Product specifications
2. Additional information on
product characteristics
3. Sterile process
validation
4. Pre-clinical studies
5. Software validation
6. Biological material
information
7. Clinical evidence
8. Risk analysis and result
9. Raw material
specification and
requirement
10. Packaging specifications
11. Stability
12. Testing (IEC),
specification, CoA
products, and QC
documents
Form E
Post Market
Evaluation
Form D
Labelling
Complaint and recall
handling system and
procedures
1. Medical device
labelling (ex. artwork Additional test by accredited
design, label, laboratories in Indonesia for
packaging, marking following product:
plate) 1. Condom
2. Explanation packaging 2. Sterile gauze
design and symbol 3. Sterile Syringe
3. Instruction of use - 4. Radiology products (which
Indonesian and contain/emit ionizing
English version radiation)
4. Lot numbering System
5. Accessories
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 NOTIFICATION
● Product license registration with notification
Medical device registration by notification
only applied to certain class A medical device
Arm sling Ice bag Ophthalmic eye shield
which is home-use and non sterile class A
Body waste
medical device that can be used independently Limb orthosis OTC Denture cleanser
receptacle
without any professional or special skill/ Cane Nipple shield Patient scale
healthcare professional assistance. Cane, crutch, and Medical adhesive tape Protective garment for
walker tips and pads. and adhesive bandage incontinence
● Notification also doesn’t apply to in vitro Nonresorbable
Medical disposable
diagnostic product. Mechanical wheelchair gauze/sponge for external
bedding
use
● Simplification of marketing authorization/ Crutch Mechanical Walker Stand-on patient scale

product license Dental floss Manual toothbrush teething ring

Elastic bandage Cold pack Therapeutic massager
Flotation cushion Medical insole Truncal orthosis
Hernia support Moist heat pack menstrual pad
Hot or cold
Manual breast pump Hot/cold water bottle
disposable pack
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 NOTIFICATION
Requirements Class A Medical Device
Registration
Administration requirement
- Production/Distribution License Class A Class A
DIFFERENCE
(Regular) (Notification)
- Quality Management Certification
(ISO 13485, ISO 9001, CE)
Evaluation of new 15 working 6 working
- Letter of Authorization application days days
- Certificate of Free Sale (imported
product) 6 working
Evaluation of renewal
7 working days days
application
Technical Requirement:
- Material Evaluation of variation
- Product Specification 10 working 6 working
and renewal with
days days
- Labelling and IFU variation application
- Accessories (if applicable)
Registration Fee same

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Guidance On Medical Device Registration

Risk Classification Tool – KMK 4475/2021 - related risk class Medical Device Product
SIKLARA and type of medical device Registration Guidelines

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http://regalkes.kemkes.go.id/

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Together we can
build a stronger and
healthier Indonesia

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