The Ministry Of Trade Requires User Manual And After-Sales Warranty Card To Be Registered In Indonesian For Electric Breast Pump Medical Device Products

As we know, electric breast pumps are classified as Class B medical devices in Indonesia. Recently, the Ministry of Trade issued Regulation No. 21/2023, point D, concerning electronic products and telematics. This regulation mandates that these products must include user manuals and after-sales warranty cards in Indonesian.

The regulation clearly states that the user manual and warranty must be registered with the Ministry of Trade (Kemendag) before the products can be marketed. It is important to note that medical devices like breast pumps have already been registered with the Ministry of Health (Kemenkes) and have received distribution permits, one of which requires the inclusion of a user manual.

Our team at DeRay Indonesia has confirmed this new regulation, issued in July, with Kemendag, emphasizing their seriousness regarding its implementation. It is expected that all distributors of breast pumps will register the user manuals and warranty cards with Kemendag. Massive inspections have already been conducted by Kemendag across all stores selling breast pumps in Indonesia. Additionally, sanctions will be imposed on distributors who fail to register the required documentation, which may include a warning letter (SP1), product withdrawal, and revocation of the company's license.

Registration of the user manual and warranty card can be done through the Kemendag portal at https://sipt.kemendag.go.id/portal/. Users must first register for access and complete the specified requirements. The registration process typically takes about 14 working days, depending on the completeness of the submitted documents

For further information, please do not hesitate to contact us.

SUMBER: PERMENDAG TENTANG PERUBAHAN PERATURAN MENTERI PERDAGANGAN NO. 26 TAHUN 2021 TENTANG PENYUSUNAN KEGIATAN USAHA DAN STANDAR PRODUK DALAM PERIZINAN PERDAGANGAN BERBASIS RISIKO.