| Name | Requirement for Registration or Notification of Medical Product Exports |
|---|---|
| Description | Legal entities or organizations exporting medical products are required to register or notify the relevant authorities of the medical products by providing details such as the product name, ingredients or manufacturer’s formula, dosage form, strength, packaging unit, international code, and source of the medical products. This is to ensure that business operations are conducted properly and in compliance with established legislation, as well as regional and international standards, while also ensuring product quality and consumer safety. |
| Comments | To ensure the safety, efficacy, and quality of disease treatment |
| Validity From | 2025-06-25 |
| Reference | Article 53 of Law 85/NA, Articles 14-18 of Decision 1470/MOH |
| Measure Type | Registration Requirement |
| Agency | Ministry of Health |
| Legal Document | - Decision on the registration and verification of medical devices, No. 1470/MOH, dated 11 July 2023. - Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 |
| UN Code | P12 |
Procedures
| # | Procedure Name | Description | Category | View Detail |
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Forms
| # | Title | Description | Issued By | File |
|---|
Commodity/s
| # | HS Code | Description |
|---|
Step-by-Step Guide
| # | Process name | Process short name | Activity |
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