What we do
Medical Device Product License
Services start from registration, to import tax & distribution. Market your products with our ready-made product & distributor licenses today!
Izin Edar/PKRT
- Pendaftaran Merek
- Pengurusan Ijin Produksi Kementrian Kesehatan (Alkes &PKRT)
- Pengurusan Ijin Distribusi Kementrian Kesehatan (Alkes)
- Pengurusan Ijin Edar Produk Alkes
- Pengurusan Ijin Edar Produk PKRT
- Pengurusan Daftar Produk BPOM
- Sertifikat ISO 17025:2017 Sistem Manajemen Laboratorium
- Sertifikat ISO 9001:2015 Sistem Manajemen Mutu (Quality System)
- Sertifikat ISO 13485:2016 Sistem Manajemen Mutu Alat Kesehatan (Medical Devices)
- Sertifikat ISO 14001:2015 Sistem Manajemen Lingkungan (Environmental)
- Sertifikasi ISO 22000:2018 Sistem Manajemen Kemanan Pangan (Food Safety)
- Setifikasi ISO 45001:2018 Occupational and Healty Management System (OHSAS)
- Setifikasi ISO 45001:2018 Occupational and Healty Management System (OHSAS)
- Sertifikasi ISO 27001:2018 Information Security Management System
- Sertifikasi ISO 10002:2018 Customer Satisfaction Management System
- FDA Certification (USA)
- CE Marking (European)
- Sertifikat Halal
Our Accomplishments
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