Setting Up a PT PMA
What Is a PT PMA?
A PT PMA (Perusahaan Terbatas Penanaman Modal Asing) is an Indonesian limited liability company with foreign investment — in effect, a foreign-owned subsidiary. Establishing a PT PMA allows a foreign medical device manufacturer to:
- Hold the IDAK and CDAKB in their own entity
- Own the NIE directly, without dependence on a third-party distributor
- Appoint and change commercial distributors freely without affecting the product registration
- Exercise direct control over regulatory affairs activities in Indonesia
Eligibility and Restrictions
Under BKPM Regulation No. 4 of 2021 and Government Regulation No. 29 of 2021:
| Requirement | Detail |
|---|---|
| Business classification | Must register under KBLI 46691 (Wholesale Trade of Laboratory Equipment, Pharmaceutical Devices, and Medical Devices for Humans) |
| Minimum investment | IDR 10 billion (approximately USD 760,000), excluding land and buildings |
| Foreign ownership | 100% foreign ownership is generally permitted for this KBLI code |
| Retail trading | Cannot be combined with retail trade activities in the same entity |
Setup Process
- Name reservation — Check and reserve company name via AHU Online (Ministry of Law and Human Rights)
- Notarial deed — Engage an Indonesian notary to draft the company establishment deed
- MoH / AHU registration — Register the company deed
- OSS registration — Register the company on the Online Single Submission (OSS) system at
oss.go.idto obtain NIB - IDAK application — Apply for IDAK via OSS (KBLI 46691)
- Facility/warehouse setup — Establish appropriate storage and distribution facilities per CDAKB requirements
- CDAKB application — Apply for and pass CDAKB inspection
- Commence NIE registrations — Once IDAK + CDAKB are in place
Timeline
Setting up a PT PMA from scratch typically takes 6–12 months before the entity is in a position to submit a first NIE application. Factor this into your market entry timeline.
PT PMA vs Using a Neutral Licence Holder
| Factor | PT PMA | Neutral Licence Holder |
|---|---|---|
| Upfront cost | High (IDR 10B + setup) | Low–moderate |
| Setup time | 6–12 months | Available immediately |
| Control over NIE | Full | Full (via contract) |
| Flexibility | Maximum | High |
| Operational responsibility | You manage CDAKB compliance | Third party manages |
| Best for | Large portfolios; long-term commitment | Faster market entry; testing the market |