Your Medical Device, Legal and Ready for Indonesia's Government Market
We assemble your device in our ISO 13485 and CPAKB certified facility, support your Ministry of Health distribution permit (AKD), and help your product reach the TKDN score that government buyers require.
ISO 13485:2016 Certified
Quality management for medical devices. Scope: Oxygen Concentrator. Issued 2024 — active surveillance.
CPAKB Certified
Cara Produksi Alat Kesehatan yang Baik — Ministry of Health RI. Issued 2025. Mandatory for medical device manufacturing in Indonesia.
BMP 14.5% Added to Your TKDN
When the TKDN certificate is issued in PEC's name, our BMP (Bobot Manfaat Perusahaan) of 14.5% is added to your product's TKDN score — helping it reach the 40% TKDN + BMP threshold.
AEO Status: Customs Facilitation
Authorized Economic Operator. Customs facilitation for your SKD/CKD component imports, which typically shortens clearance time.
Local Products Come First
When a domestic product with TKDN + BMP of at least 40% exists for a given specification, government buyers must purchase domestic products with TKDN of at least 25%. Imported equivalents can be frozen in the Ministry of Health sector catalogue.
CPAKB & ISO 13485 Take Years to Build
Setting up a compliant medical device production facility in Indonesia from scratch requires major investment and takes 2–4 years. Most foreign brands can't afford to wait that long.
Imported Means Ineligible
A fully imported (CBU) product has no TKDN. Where a qualifying local alternative exists, it cannot be chosen in government procurement — no matter how good or how competitively priced it is.
We're the Shortcut You've Been Looking For
PEC already holds the facility certifications required to manufacture medical devices in Indonesia. You bring your technology and brand — we bring the quality system, manufacturing capability, and regulatory experience that took years to build.
Your product stays under your brand and your distribution permit, while being made in Indonesia and eligible for government procurement.
A Clear Path to TKDN ≥ 25%
Local assembly at our Sidoarjo facility counts toward TKDN. The final score depends on how many components and processes are local — we assess it with you before you commit.
Distribution Permit (AKD) Support
The distribution permit (Nomor Izin Edar, AKD) is registered in your name. We provide the manufacturing documentation from our ISO 13485 and CPAKB certified facility that your application needs.
e-Catalogue Listing Support
Once your product holds its distribution permit and TKDN certificate, we support its listing on the government e-Catalogue (katalog.inaproc.id).
Full Traceability System
Every unit assembled carries barcode-tracked records from component to finished product — meeting medical device quality documentation requirements without exception.
End-to-End Manufacturing Service for Medical Devices
From component import to e-Catalogue listing — we handle every step so your brand can focus on what it does best.
Contract Assembly (EMS)
Local assembly of your SKD/CKD components on our certified conveyor and electro-medical assembly lines in Sidoarjo, East Java.
TKDN Certification
We calculate, document, and submit your TKDN application to Kemenperin. Our experienced team knows exactly what maximizes your score.
Local Material Sourcing
We identify and qualify Indonesian component suppliers to increase your TKDN percentage and reduce foreign exchange exposure on your BOM.
Distribution Permit (AKD) Support
We prepare the manufacturing and quality documents for your Ministry of Health distribution permit (Nomor Izin Edar) and support you through to approval.
e-Catalogue Registration
We assist in listing your product on the government e-Catalogue (katalog.inaproc.id), where public hospitals and health centres procure.
In-House Injection Molding
Plastic housings and parts produced in our own facility — one of the most direct ways to raise your product's local content.
From Your Product to Indonesia Government Market
Built on our experience arranging TKDN and type approval for 4G LTE devices since 2013. Here's what the journey looks like.
Product Feasibility
We assess your device against our assembly capabilities and certification scope
TKDN Assessment
Free preliminary TKDN calculation — we tell you what score is achievable before you commit
Trial Assembly
Pilot production run under ISO 13485 documentation — sample units for your distribution permit application
Permit & TKDN Certificate
Ministry of Health distribution permit (AKD) and Kemenperin TKDN certificate
e-Catalogue Launch
Your product listed on the government e-Catalogue, available to public hospitals and health centres
Three Certifications That Took Years to Build — Available to You Now
These are the foundations that let PEC take on medical device contract manufacturing. We didn't just get these certifications — we built a quality system around them.
ISO 13485:2016
Quality Management System for Medical Devices · Active since 2024
The global standard for medical device quality management. Our scope covers Oxygen Concentrator manufacturing — and is being extended to cover Contract Manufacturing for other medical devices.
CPAKB
Cara Produksi Alat Kesehatan yang Baik · Ministry of Health RI · 2025
Indonesia's mandatory Good Manufacturing Practice for medical devices. Required by Kemenkes for any company wishing to manufacture or assemble alkes legally on Indonesian soil.
AEO + BMP 14.5%
Authorized Economic Operator · Bobot Manfaat Perusahaan · Active
AEO status provides customs facilitation for your SKD/CKD components. When the TKDN certificate is in PEC's name, our 14.5% BMP is added to your product's TKDN score in government procurement.
Our Global Partners
Global and national brands we have served across telecommunications, consumer electronics, and media.
Medical Devices Within Our Scope & Capability
Our assembly lines, injection molding, and certified QMS cover a range of electro-medical and diagnostic devices. Our current ISO 13485 scope covers oxygen concentrators; other devices require a certification scope extension, which we plan together with you.
Oxygen Concentrator
Home care & clinical use
ISO 13485 Scope ★Digital Blood Pressure Monitor
Upper arm & wrist types
Scope Extension NeededBlood Glucose Meter
Handheld, for home & clinic
Scope Extension NeededThermometer
Digital & infrared
Scope Extension NeededNebulizer
Compressor & mesh types
Scope Extension NeededReady to Enter Indonesia's Healthcare Procurement Market?
Send us your product specifications for a free preliminary TKDN feasibility assessment. We'll tell you within 5 business days what TKDN score is achievable and what the path to e-Catalogue looks like for your device.
No commitment required. No consultant fees for the initial assessment.