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.
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Dec 19, 2022 · 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
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Aug 12, 2024 · address: [email protected] 2. Pre-Market Control Division, MDA will receive the application and send an acknowledgement email to the applicant. 3. Pre-Market Control Division, MDA will issue a payment advice to the Finance Unit (MDA) and the Finance Unit will issue an invoice for the payment fee to the applicant via email.
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Dec 19, 2022 · MDA/GL/04 Januari 2022 iii PREFACE This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it. This Guidance Document shall be read in conjunction with the …
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MDA/GL/MD-01 How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737) Third Edition: MDA/GL No. 2 How to apply for establishment License under medical device act 2012 ( Act 737) MDA/GL No. 2 How to Apply for Apply for In-Vitro Doagnostic (IVD) the Medical Device Registration under Act 737: MDA/GL/04
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