Guidance Document - Medical Device Authority (MDA)

Feb 2, 2024 · MDA/GD/0008 : First Edition : March 2014 : Declaration of Conformity (DOC) MDA/GD/0025 : First Edition : February 2016 : Change Notification for Registered Medical Device: MDA/GD/0020 : Fourth Edition : 21 November 2022 : Guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737) MDA/GL/MD-01 : …

Harga Mesin Air Isi Ulang - Aqualux

Jun 8, 2023 · MDA/GL/08 1 1 Introduction 1.1 Section 5 (1) of Medical Device Act 2012 (Act 737) requires a medical device to be registered under the Act before it can be imported, exported or placed in the market. For that purpose, an application for the registration of a medical device must be made according to the

Kontak - Aqualux

MARKETING : 1. Widya : 0852-79797-384 2. Erva : 082-260-260-803 3. Yuli : 085-816-865-548 Email : [email protected] KANTOR PUSAT Kudus : Jl. Lingkar Ngembal No.36 Ngembalrejo, Kudus KANTOR CABANG Semarang : Ruko Emerald Blk. f No

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Nov 29, 2023 · ：GDPMD（GDPMDCAB；GDPMD1～2）、MDAEstablishment License（MDA EL：4000＋250 RM）（ …

Melihat Perbandingan Antara Air Biru Vs Aqua - Aqualux

Jul 10, 2021 · Melihat Perbandingan Antara Air Biru Vs Aqua – Aqualux Water Purifier Mungkin terlihat aneh jika ingin membandingkan antara produk air isi ulang Air Biru vs Aqua.Kedua produk ini sama-sama menjual air minum dalam kemasan galon.

Monkeypox Test Kits - mda.gov.my

Sep 25, 2024 · Please refer to guideline MDA/GL/09 GUIDELINE FOR REGISTRATION OF ORTHOPOXVIRUS (MONKEYPOX) IVD TEST KITS for further information on the main documents for registration, such as the CSDT, EPSP, DOC, Safety and Performance reports, Labelling/IFU/Brochure, and other related documents.

HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION …

Dec 19, 2023 · HOW TO APPLY FOR MEDICAL DEVICE REGISTRATION UNDER MEDICAL DEVICE ACT ...

Monkeypox Test Kits - Medical Device Authority (MDA)

Please refer to guideline MDA/GL/09 GUIDELINE FOR REGISTRATION OF ORTHOPOXVIRUS (MONKEYPOX) IVD TEST KITS for further information on the main documents for registration, such as the CSDT, EPSP, DOC, Safety and Performance reports, Labelling/IFU/Brochure, and other related documents.

FAQs - Registration, Licensing & Enforcement - Medical …

Please refer to document: MDA/GL No. 2 - How to apply for establishment License under medical device act 2012 ( Act 737) FAQs - Registration, Licensing & Enforcement. ... MDA will not provide any letter for tendering agent. If they are still facing a problem, the tendering agent may call directly to MDA. FAQs - Registration, Licensing ...

Daftar Paket Harga Mesin AMDK dan Spesifikasinya

4. Paket Mineral & Royal Executive GL dengan harga Rp49.850.000,-5. Paket Mineral & RO Executive G dengan harga Rp39.975.000,-6. Paket Mineral Executive GL PLUS Anti Bakteri dengan harga Rp38.975.000,-7. Paket Mineral Executive G dengan8.

COVID-19 RTK (SELF-TEST) -REQUIREMENTS - Medical …

Dec 19, 2022 · MDA Guideline Conditional Approval For COVID-19 Rapid Test Kit (Self-Test) (MDA/GL/05). 2. Scope and application This guidance document specifies requirements for conditional approval of Covid-19 RTK (self-test) to be placed in the Malaysian market, based on Circular Letter No.1/2021.