On December 19, 2024, the Indonesian Ministry of Health issued Letter No. FR.03.01/E.V/2728/2024, officially classifying dermal fillers as medical devices. This announcement provides guidance to facilitate the importation of dermal fillers into Indonesia while ensuring compliance with regulatory requirements:
Classification of Dermal Fillers
- Dermal fillers are categorized as medical devices under the General Surgical Equipment and Plastic Surgery category, specifically in the Prosthetic Surgical Equipment subcategory.
- These products are classified as high-risk (Class D) medical devices.
Regional Regulatory Alignment
- The classification of dermal fillers as medical devices aligns with the global harmonisation of regulations and follows practices in other ASEAN countries, including Singapore, Malaysia, and Thailand.
Customs and HS Code
- The HS Code for dermal fillers, as determined in collaboration with the Directorate General of Customs of the Ministry of Finance, is 3304.99.90.
Product Approval Requirements
- As outlined in Regulation of the Minister of Health Number 62 of 2017, Article 4, Paragraph 1:
- Medical devices, in vitro diagnostic medical devices, and household health supplies intended for manufacturing, importation, assembly, or repackaging for distribution in Indonesia must obtain a product approval license.
- This requirement applies to dermal fillers and other relevant products.
Import Certificate
- The Ministry of Health does not require an Import Certificate for medical devices that have already received a product approval license.
For more details, you can access the full announcement here: Dermal Filler Product Information (in Indonesian, no English translation available).
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