Approximate General Timeline

Approximate Timeline For Entity Establishment

M1 M2 M3 M4 M5 M6 M7 M8 M9 M10

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

1.1.
General License

1.1.1 Deed of Establishment + Decree of MoLHR

Taxpayer Registration Number (Nomor Pokok Wajib Pajak

"NPWP")
1.1.2

1.1.3
Single Business Registration (Nomor Induk Berusaha - "NIB") Legal

Domicile Certificate from Jababeka and Kelurahan Serta Jaya

1.1.4
Company's Manpower Social Security Number and Health
Social Security Number
1.1.5

1.2 Commercial License (Each KBLI)

KBLI 21015 (Medical Device Industry)

1.2.1
Approximate Timeline for Construction
M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2

2,1 Consultation with Regulatory

Authorities

BPOM
2.1.1 1. Discussion related process,
requirements, layout.
2. Finalization of Layout design
2.1.2 MOH
Preparation of Construction
2,2

2.2.1 Search CM company

2.2.2 Contract with CM Company
2.2.3
Open tender construction company
2.2.4
Contract with construction company
2.2.5 Finalization DED (Detailed
Engineering Design)
Construction
2,3

PQ (Room Performance Qualification)

2,4

SPPL (Ijin Lingkungan)

2,5

2.5.1 Preparation dokuments for

SPPL/UKL UPL
2.5.2
Documents submission
2.5.3 Documents's review by
Authorization
2.5.4 Obtain SPPL certificate
Approximate Timeline for GMP Audit
M18 and
M13 M14 M15 M16 M17
onwards
ITEM

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
5,1 Documents Prepartion
5.1.1 QMS
5.1.2 RIV
5.1.3 SOP of QA
5.1.4 SOP of QC
5.1.5 SOP of Production
5,2 Industrial license
5.2.1 Apply industrial license to MOH
5.2.1 Obtain Industrial License
5,3 GMP Audit
5.3.1 Submitting audit request to BPOM
5.3.2 GMP audit
5.3.3 Obtaining GMP Certificate
 Regulatory Framework:

Law Number 11 of 2020 on Job Creation (“Law 11/2020”)

Government Regulation Number 5 of 2021 on Implementation of Risk-Based Business Licensing

(“GR 5/2021”)

Government Regulation Number 8 of 2021 on Capital of Limited Liability Company, as well as

Establishment, Amendment and Disbanding of Business Entities Classified as Micro and Small
Business Entities (“GR 8/2021”)
Government Regulations Number 22 Year 2021 regarding the Organization of Environmental
The End Protection and Management (“GR 22/2021”)

Presidential Regulation Number 49 of 2021 on the Amendment of Presidential Regulation Number

10 of 2021 on Investment Business Lines (“PR 49/2021”)

Indonesian Investment Coordinating Board (Badan Koordinasi Penanaman Modal or BKPM)

Regulation Number 4 of 2021 on Guidelines and Procedures for Risk-Based Business Licensing
Services and Investment Facilities (“BKPM Regulation 4/2021”)
Ministry of Health Regulation no 14 of 2021 on Standards of Business Activities and Products on
The Implementation of Risk Based Business Licensing in Health Sector (“MOH Regulation
14/2021”)
Ministry of Industry Regulation No. 9 of 2021 on Standards of Business Activities and Products on
The Implementation of Risk Based Business Licensing in Industry Sector (“MoI Regulation
9/2021”)