01 / 04
Company incorporation
Explore service↗PT PMA
Foreign-owned company setup, business classification and company licensing readiness.
INDONESIA MARKET ENTRY & REGULATORY SERVICES
Enter Indonesia.
Move forward
with clarity.
From foreign-owned company establishment to medical device distribution and product registration, we help you navigate the practical work behind Indonesia market access.
✳Business setup. Distribution licensing. Quality compliance. Product registration.
YOUR MARKET-ENTRY BLUEPRINT INDONESIA
One market.
Four possible workstreams.
01
PT PMACorporate establishment & business scope
↗02
IDAKMedical device distribution licensing
↗03
CDAKBDistribution quality certification
↗04
AKLImported product registration
↗Every project follows its own requirementsRECOVE / 2026
PLAN.
PREPARE.
PROGRESS.
PREPARE.
PROGRESS.
PT RECOVE GROUP INDONESIAPRIVATE REGULATORY SUPPORTLET’S BUILD YOUR NEXT STEP ↗
Foreign investors✳Medical device importers✳Healthcare distributors✳Overseas manufacturers
OUR SERVICES
From incorporation
to market access.
Focused support for the decisions, documentation and regulatory steps that shape your launch in Indonesia.
02 / 04
Distribution licensing
Explore service↗IDAK
Medical device distributor licensing, personnel, facilities and operating requirements.
03 / 04
Distribution quality
Explore service↗CDAKB
Quality procedures, implementation records and distribution certification readiness.
04 / 04
Product registration
Explore service↗AKL
Imported medical device registration support, technical dossiers and submission preparation.
Each service can be scoped individually. Regulatory requirements depend on the entity, activities, product and applicable rules.
A simpler way to approach a complex market. ↗
THE RECOVE APPROACH
Local context.
Practical direction.
Clear next steps.
Regulatory work is easier when you know what comes first. Our approach begins with the real business model—not a generic list of permits.
01
Understand the business
Who owns the company, what products are involved, and what activities are planned?
02
Map the requirements
Identify the licences, quality documentation and submissions relevant to your situation.
03
Support execution
Prepare the agreed workstream and coordinate documentation through the applicable process.
FIND YOUR STARTING POINT
Not sure where
to begin?
Select your immediate goal and explore the likely first steps. This guide is informational, not a licensing determination.
STEP 01 / CHOOSE YOUR GOAL
What are you planning to do?
Choose the one that best matches your next move.
YOUR SUGGESTED STARTING POINT
Start with PT PMA incorporation
Some projects need multiple workstreams; any required sequence and eligibility must be assessed against current regulations.
HOW WE WORK
Four steps to a
better-prepared submission.
A structured approach, with transparent scope and documentation needs at every stage.
01
Discovery
Understand your company, planned activities, products and existing authorisations.
02
Gap assessment
Identify missing documents, regulatory dependencies and practical priorities.
03
Preparation
Organise the agreed documentation and application-readiness workstream.
04
Application support
Coordinate submission steps and assist with responses where included in scope.
COMMON QUESTIONS
The questions
worth asking
before you apply.
Rules vary with business activity and device category. These answers describe typical considerations, not case-specific legal advice.
What is the difference between IDAK, CDAKB and AKL?
They address different regulatory areas. IDAK relates to medical device distributor licensing, CDAKB to good distribution practice and certification, and AKL to marketing authorization for imported devices. The exact combination depends on the applicant, activities and product.
Can a foreign company apply directly for AKL?
An imported-device application generally needs an eligible Indonesian applicant or registration holder, with appropriate manufacturer authorization and supporting technical documentation. We can review your proposed structure before any application.
Does PT PMA incorporation automatically authorize medical device sales?
No. Corporate establishment and the NIB do not automatically replace sector-specific medical device distribution and product requirements. These should be assessed separately.
Can you guarantee approval or a fixed timeline?
No. Approval decisions and review periods are controlled by the relevant authorities. We can help assess document completeness, plan the workflow and respond to requests for additional materials.
Do you offer separate services or a combined package?
Both. You can engage support for a single workstream, or ask for an integrated scope that covers company setup, distribution licensing, quality compliance and product registration.
What should I share for an initial assessment?
Your intended business activities, ownership structure (for PT PMA), existing Indonesian licences, product type and intended use, manufacturer country, and available product or quality documentation.
Official regulatory references
General guidance only. Current rules, classification and agency instructions must be checked for each case.
START HERE
Let’s get your
next step right.
Tell us what you plan to establish, distribute or register. We’ll start by understanding your business model and the documentation you already have.
✓ A practical starting-point discussion✓ Review of likely documentation needs✓ An agreed service scope before work begins
PT Recove Group IndonesiaCorporate site: recovegroup.id ↗
Independent, private sector support. Not a government licensing authority.
Independent, private sector support. Not a government licensing authority.
Tell us about your project.
Complete the details below to prepare a consultation enquiry.