Our Services
Registration for Medical Device and In-Vitro Diagnostic (IVD) Distribution License
About this service
All medical devices, whether domestically produced or imported, must be officially registered with the Ministry of Health through the Online Medical Device Registration platform (regalkes). This platform is integrated with the OSS (Online Single Submission) system, which facilitates the digital licensing and registration process for medical devices. To ensure your medical devices meet all requirements and are registered according to applicable regulations, contact us. We are ready to assist you throughout the entire medical device registration process, from start to finish, so you can focus more on business development without worrying about legality and regulatory aspects.
What You Get
Full assistance throughout the entire product registration process.
Preparation and review of documents according to Ministry of Health regulations.
Direct consultation with an expert regulatory affairs team.
Latest regulatory information to maintain product compliance.
A faster and more efficient registration process.
Regular monitoring and status reports on registration.
Requirements
Download AttachmentAdministrative Data
Product Information Data
Specification and Quality Assurance Data
Labeling Data
Post-Market Evaluation Data
Share Data
Tariff PNBP
State licensing registration fees.
| NEW APPLICATION | |||||
|---|---|---|---|---|---|
| Class | Initial evaluation service promise | Deadline to complete additional data | Additional data evaluation service promise | PNBP Tariff (Rp.) | |
| DN | LN | ||||
| A | 10 HK | 15 HK | 10 HK | 10 HK | 1.500.000 |
| B | 20 HK | 30 HK | 10 HK | 10 HK | 3.000.000 |
| C | 20 HK | 30 HK | 10 HK | 10 HK | 3.000.000 |
| D | 30 HK | 40 HK | 15 HK | 10 HK | 5.000.000 |
