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MDA/GD/00XX September 2019 Status: 30.20MEDICAL DEVICE GUIDANCE DOCUMENTNOTIFICATION OF REFURBISHED MEDICAL DEVICEMedical Device Authority MINISTRY OF HEALTH MALAYSIA/GD/00xxContentsPagePreface ...................................................................................................................iii1Introduction

How to fill out medical device guidance document

How to fill out medical device guidance document

1. Gather all necessary information about the medical device being submitted for guidance document
2. Fill out all required sections of the guidance document including product details, intended use, risk assessment, testing information, and labeling details
3. Provide any supporting documentation or data that may be required by the regulatory authorities
4. Submit the completed guidance document to the appropriate regulatory agency for review and approval

Who needs medical device guidance document?

1. Manufacturers of medical devices who are seeking regulatory approval or guidance for their products

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What is medical device guidance document?

A medical device guidance document is a document that provides instructions and recommendations on how to comply with regulations and standards for the design, manufacturing, testing, and distribution of medical devices.

Who is required to file medical device guidance document?

Manufacturers, importers, and distributors of medical devices are required to file a guidance document.

How to fill out medical device guidance document?

The medical device guidance document can be filled out electronically through the designated regulatory authority's online portal or by submitting a physical copy with all required information.

What is the purpose of medical device guidance document?

The purpose of a medical device guidance document is to ensure that medical devices meet safety and efficacy standards, and are in compliance with regulatory requirements before being placed on the market.

What information must be reported on medical device guidance document?

The guidance document typically requires information on the device's design, intended use, manufacturing process, labeling, testing results, and any known risks or adverse events.