The Department of Medical Equipment and Construction (DMEC) is the legal entity that regulates the registration of medical devices in Vietnam, under the leadership of the Ministry of Health before medical devices are marketed, imported, exported, or manufactured. Decree No. 98/2021 published on November 8, 2021, which was previously regulated by Decree No. 36/2016/ND-CP as amended by Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP. The transition period for some Class C and D products and documentation will last for one year before the new regulations are fully implemented on January 1, 2022.

Definition of Medical Devices according to Vietnam are any equipment, tools, materials and chemicals, software needed, used alone or in combination for the purpose of preventing, examining, diagnosing, and/or reducing disease or checking, replacing, modifying, or offer surgical support during examination and treatment. ️

Companies wishing to register medical devices in Vietnam must first be registered locally by having Establishment License which is obtained from the Department of Local Planning and Investment. In order to have an Establishment License, companies wishing to register medical devices must have applicable standards such as:

• Foreign dealers with medical devices or with permission from medical device owners to sell medical equipment have representative offices in Vietnam.

• Has the authority by the owner of the medical device to register

• Medical device owners‎

In Vietnam, medical devices are categorized based on their intended purpose according to Circular 39/2016, risk factors, mode of distribution, and amount of body intrusion. Vietnam strictly adheres to the GHTF recommendations for classifying medical devices, which include devices:

• Class A

• Class B

• Class C

• Class D

With a risk range from low to high. The classification of medical devices in Vietnam is divided into 2 types, namely General Medical Devices and IVD Medical Devices. IVD medical device classification has 4 categories:

• Class A

• Class B

• Class C

• Class D

According to 7 risk based rules and AMDD guidelines. There are several factors that influence the risk classification based on the purpose of use, expertise of users of medical devices and the impact of information on medical devices on the community.

In the registration of medical devices and IVD products can be grouped into 1 application to obtain a certificate of registration of medical devices. The grouping categories are:

• Single

• Familly

• System

• Set

• IVD Test Kit

• IVD Cluster

Untuk mendaftarkan alat kesehatan di Vietnam, pertama yang di lakukan adalah menentukan klasifikasi sesuai dengan tujuan penggunaan dan tingkat resiko. hasil klasifikasi akan dikeluarkan oleh pemegang pendaftaran atau pemegang lisensi.

Permohonan pendaftaran alat kesehatan kelas A dan B harus di unggah secara online melalui https://dmec.moh.gov.vn/ dan menunggu disetujui. Pada tanggal 1 Januari 2022, Kementerian Kesehatan Vietnam membuat peraturan bahwa semua alat kesehatan dengan klasifikasi A dan B memerlukan Lisensi Market Authorization (MA). Pemberitahuan Standar yang berlaku akan dikeluarkan Ketika permohonan disetujui dengan validitas seumur hidup.

Sebelum tanggal 1 Januari 2022, permohonan untuk kelas C dan D memerlukan Lisensi Impor dan untuk sekarang memerlukan permohonan Market Authorization (MA). MA tidak memiliki batas untuk masa berlaku sementara izin impor memiliki batas waktu. Alat kesehatan C dan D dapat terus di impor secara bebas sampai 31 Desember 2022, untuk yang tidak tercantum dalam Surat Edaran 30, hanya dengan dokumen klasifikasi.

PMS merupakan tindakan yang diwajibkan kepada pemegang lisensi dari Department of Medical Equipment and Construction (DMEC), sesuai dengan ASEAN Medical Device Directive (AMDD) yang berlaku pada 1 Januari 2015. Setiap negara anggota ASEAN dapa bebas dalam menerapkan persaratan Post Market Surveillance (PMS) ini karena setiap negara memilki hak dan kekhuasaannya masing masing.
Pemegang lisensi diharuskan untuk menyimpan catatan riwayat alat kesehatan dengan catatan distribusi, catatan kejadian, dan lain lain.