Our Services
Extension/Modification of Medical Device & In-Vitro Diagnostic (IVD) Distribution License
About this service
The extension or modification of a medical device distribution license, as well as the extension of a PKRT license, are crucial aspects that every manufacturer planning to sell products in the Indonesian market must consider. This process is vital because failure to obtain or renew these permits can have serious consequences, including the loss of access to the desired market. The impact can be significant, leading to a decline in sales that can affect overall business sustainability. Therefore, ensuring these licenses are always active and compliant with applicable regulations is a strategic step for successful medical device marketing in Indonesia.
What You Get
Initial regulatory consultation to determine product classification.
Complete assistance in preparing registration documents.
Document review to ensure compliance with Ministry of Health standards.
Document review to ensure compliance with Ministry of Health standards.
Monitoring of registration status until the permit is issued.
Official distribution license number for legal distribution in Indonesia.
Requirements
Download AttachmentAdministrative Data
Product Conformity Documents
Supporting Data
Tariff PNBP
State licensing registration fees.
| EXTENSION | ||||
|---|---|---|---|---|
| Class | Initial evaluation service promise | Deadline to complete additional data | Additional data evaluation service promise | PNBP Tariff (Rp.) |
| A | 7 HK | 10 HK | 10 HK | 500.000 |
| B | 7 HK | 10 HK | 10 HK | 1.000.000 |
| C | 7 HK | 10 HK | 10 HK | 1.000.000 |
| D | 7 HK | 10 HK | 10 HK | 1.000.000 |
| MODIFICATION | ||||
|---|---|---|---|---|
| Class | Initial evaluation service promise | Deadline to complete additional data | Additional data evaluation service promise | PNBP Tariff (Rp.) |
| A | 10 HK | 10 HK | 10 HK | 500.000 |
| B | 10 HK | 10 HK | 10 HK | 1.000.000 |
| C | 10 HK | 10 HK | 10 HK | 1.000.000 |
| D | 10 HK | 10 HK | 10 HK | 1.000.000 |
| EXTENSION & MODIFICATION | ||||
|---|---|---|---|---|
| Class | Initial evaluation service promise | Deadline to complete additional data | Additional data evaluation service promise | PNBP Tariff (Rp.) |
| A | 10 HK | 10 HK | 10 HK | 500.000 |
| B | 10 HK | 10 HK | 10 HK | 1.000.000 |
| C | 10 HK | 10 HK | 10 HK | 1.000.000 |
| D | 10 HK | 10 HK | 10 HK | 1.000.000 |
