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Questions and Answers
What does Annex 7 focus on?
What does Annex 7 focus on?
What type of languages can Member States require for the label of a medical device?
What type of languages can Member States require for the label of a medical device?
Which document specifies the structure of the AMDD?
Which document specifies the structure of the AMDD?
What is the purpose of Article 11 in relation to medical devices?
What is the purpose of Article 11 in relation to medical devices?
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In which annex do you find information related to Post Marketing Alert System (PMAS) requirements?
In which annex do you find information related to Post Marketing Alert System (PMAS) requirements?
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According to the provided information, which language is required for labeling homeused medical devices in Malaysia?
According to the provided information, which language is required for labeling homeused medical devices in Malaysia?
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Under AMDD, what must be the language of the label for medical devices according to the text?
Under AMDD, what must be the language of the label for medical devices according to the text?
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What is required for establishments placing medical devices in the market in Malaysia, as per the text?
What is required for establishments placing medical devices in the market in Malaysia, as per the text?
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Which section of the Act prohibits misleading claims about medical devices in advertisements?
Which section of the Act prohibits misleading claims about medical devices in advertisements?
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What type of document do all establishments placing medical devices in Malaysia have to comply with, as per the text?
What type of document do all establishments placing medical devices in Malaysia have to comply with, as per the text?
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Which body may require the use of Bahasa Malaysia for types of medical devices other than homeused devices?
Which body may require the use of Bahasa Malaysia for types of medical devices other than homeused devices?
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What is the purpose of the common submission dossier template in the context of medical devices?
What is the purpose of the common submission dossier template in the context of medical devices?
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What is one of the key goals of Malaysia's medical device regulatory overhaul plans?
What is one of the key goals of Malaysia's medical device regulatory overhaul plans?
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How does Malaysia plan to enhance its medical device regulatory framework?
How does Malaysia plan to enhance its medical device regulatory framework?
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Which statement accurately reflects a key aspect of Malaysia's medical device updates?
Which statement accurately reflects a key aspect of Malaysia's medical device updates?
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What is the significance of Act 737 in relation to Malaysia's medical device control?
What is the significance of Act 737 in relation to Malaysia's medical device control?
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How does the Malaysian Device Authority plan to further support Malaysia's medical device regulatory framework?
How does the Malaysian Device Authority plan to further support Malaysia's medical device regulatory framework?
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Study Notes
Annex 7 Overview
- Focuses on the labeling and information requirements for medical devices.
- Establishes standards for compliance with language and content.
Language Requirements for Medical Device Labels
- Member States can require the use of official languages or other languages deemed appropriate for labels.
- In Malaysia, homeused medical devices must be labeled in Bahasa Malaysia.
Structure of the AMDD
- Specified in a structured document designed to organize regulatory requirements for medical devices.
Purpose of Article 11
- Aims to address the clinical evaluations and evidence required for the safety and efficacy of medical devices.
Post Marketing Alert System (PMAS)
- Information related to PMAS requirements can be found in Annex X.
Language for Homeused Medical Devices in Malaysia
- Labels must be in Bahasa Malaysia.
Label Language Requirements under AMDD
- The language of labels for medical devices must be clear, understandable, and consistent with local regulations.
Requirements for Establishments in Malaysia
- Establishments must comply with local regulatory documentation and standards when placing medical devices in the market.
Prohibition of Misleading Claims
- Section 20 of the Act prohibits misleading claims in advertisements related to medical devices.
Compliance Document for Establishments
- All establishments are required to comply with the Medical Devices Act and associated regulations.
Use of Bahasa Malaysia for Other Devices
- The Malaysian Device Authority may require the use of Bahasa Malaysia for other types of medical devices beyond homeused devices.
Common Submission Dossier Template
- Created to streamline submissions of information for regulatory purposes regarding medical devices.
Key Goals of Malaysia's Regulatory Overhaul
- Aims to improve safety, quality, and compliance in the medical device sector.
Enhancement of Regulatory Framework
- Plans to adopt better standards and practices to govern medical device approval and monitoring.
Key Aspect of Medical Device Updates in Malaysia
- Focus on transparency and rigorous evaluation processes for medical devices.
Significance of Act 737
- Establishes the legal framework for controlling and regulating medical devices in Malaysia.
Support for Regulatory Framework
- The Malaysian Device Authority aims to provide improved guidance and resources for compliance and regulatory matters.
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Description
Test your knowledge on the technical documents required for medical devices in accordance with European regulations. The quiz covers topics like common technical documents, submission dossier templates, post-marketing alert systems, product owner's declaration, labelling, and claims.
