The Ministry of Health has issued an announcement to ensure the smooth importation of medical devices into Indonesia, specifically addressing the importation process for dermal fillers. This clarification aims to enhance regulatory compliance and streamline procedures for medical device distributors.
Key Points of the Announcement
- Dermal Filler Classification
Authorities classify dermal fillers as medical devices under General Surgery and Plastic Surgery Equipment, sub-category Prosthetic Surgery Equipment, with a product type of Dermal Filler. They fall under the high-risk category (Class D). - Harmonization with Global Regulations
In alignment with globally harmonized regulations, dermal fillers are classified as medical devices. This classification is consistent across ASEAN countries, including Singapore, Malaysia, and Thailand. - Harmonized System (HS) Code Assignment
The Directorate General of Customs and Excise (Ditjen Bea dan Cukai) of the Ministry of Finance has assigned 3304.99.90 as the HS Code for dermal fillers. - Distribution Permit
According to Minister of Health Regulation No. 62 of 2017, Article 4, paragraph 1, manufacturers, importers, assemblers, and repackagers of all medical devices, including in-vitro diagnostic medical devices and household health supplies (PKRT), must obtain a Distributior Permit (Izin Edar) before distributing them in Indonesia. - Importation Without Additional Import Certificates
Beyond the marketing authorization mentioned above, the Ministry of Health does not issue Import Certificates (Surat Keterangan Impor) as an additional import requirement for medical devices that have already obtained Distribution Permit.
Ensuring Regulatory Compliance
These updated guidelines provide clarity for medical device importers and ensure compliance with Indonesian health regulations. By classifying dermal fillers as medical devices and aligning with global standards, the Ministry of Health aims to facilitate a transparent and standardized importation process.
