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MEDICAL DEVICE CONTROL DIVISION Ministry of Health, MalaysiaMEDICAL DEVICE GUIDANCE DOCUMENTED GUIDANCE ON THE COMMON SUBMISSION DOSSIER TEMPLATEDRAFTCommon Submission Dossier TemplateTable of Contents 1.0Introduction

How to fill out medical device control division

How to fill out medical device control division:

1. Understand the regulatory requirements: Familiarize yourself with the regulations and guidelines that govern the medical device industry, such as the FDA regulations in the United States.
2. Develop a quality management system: Establish a comprehensive quality management system that encompasses aspects like document control, risk management, complaint handling, and corrective and preventive actions.
3. Identify and classify medical devices: Determine the classification of the medical devices your organization deals with based on factors like their intended use and potential risks.
4. Implement design controls: Implement design controls to ensure that medical devices are developed and manufactured according to predetermined specifications, including design verification, validation, and transfer activities.
5. Establish a post-market surveillance system: Implement a system to monitor the performance and safety of medical devices after they are on the market, including processes for adverse event reporting and trending analysis.
6. Conduct training and awareness programs: Train employees on the importance of medical device control and provide ongoing awareness programs to ensure compliance with regulations and best practices.

Who needs medical device control division:

1. Medical device manufacturers: Companies involved in designing, producing, and distributing medical devices need a dedicated medical device control division to ensure compliance with regulations and maintain product quality and safety.
2. Healthcare facilities: Hospitals, clinics, and other healthcare facilities that use and maintain medical devices also require a medical device control division to oversee the proper management and use of these devices.
3. Regulatory authorities: Government agencies responsible for regulating the medical device industry may have their own medical device control divisions to enforce compliance with regulations and conduct inspections and audits.
4. Medical device consultants: Consultants specializing in medical device regulations and quality management may offer services related to medical device control division, assisting organizations in establishing and maintaining compliant systems.
5. Research and development organizations: Companies or institutions engaged in the research and development of new medical devices often have a medical device control division to ensure the proper design, testing, and documentation of their inventions.

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What is medical device control division?

The medical device control division is responsible for regulating and overseeing the medical devices used in healthcare.

Who is required to file medical device control division?

Manufacturers, importers, and distributors of medical devices are required to file with the medical device control division.

How to fill out medical device control division?

To fill out the medical device control division, the required information must be accurately provided and submitted according to the guidelines set by the division.

What is the purpose of medical device control division?

The purpose of the medical device control division is to ensure the safety, efficacy, and quality of medical devices used in healthcare settings.

What information must be reported on medical device control division?

Information such as device classification, registration number, manufacturing details, and adverse events must be reported on the medical device control division.