PROCEDURES FOR ANNOUNING THE ELIGIBILITY TO MANUFACTURE MEDICAL EQUIPMENT FOR THE ENTERPRISE

Manufacturing medical equipment is a conditional industry, which means that an institution can only manufacture medical equipment after submitting a statement of eligibility to do so in accordance with rules. So, what are the requirements for dossiers and procedures for declaring eligibility to produce medical equipment?

Legal basis:

- Law on Investment 2020;

- Decree 36/2016/ND-CP on medical equipment management.

1. Declaration of Eligibility to Manufacture Medical Equipment (Dossier of Declaration of Eligibility to Manufacture Medical Equipment)

- A written announcement of production eligibility;

- A manpower declaration form;

- A document detailing the assignment and appointment of the person in charge of the production facility's expertise;

- A confirmation of working hours;

- The person in charge of the specialty's diplomas and training certifications;

- A certificate stating that the quality management requirements have been met;

- Documents demonstrating that the location, area, and manufacturing workshop are appropriate for the type of medical equipment that the company produces;

- Dossier on manufacturing equipment, processes, and quality control in compliance with the requirements of the type of medical equipment manufactured by the establishment;

- Hire a qualified quality inspection company to inspect the medical equipment that the company produces;

- Medical equipment preservation warehouse dossier;

- Records of medical equipment transportation methods.
2. Declaration of eligibility to produce medical equipment procedures

Step 1: Before beginning the production of medical equipment, the director of the medical equipment manufacturing facility must submit to the Department of Health where the facility is located a dossier of declaration of eligibility for production as stipulated.

Step 2: The Department of Health will issue the establishment that publishes the receipt of the application for declaration of ability to manufacture medical equipment after receiving a complete and valid application.

Step 3: Within three working days of receiving the application, the Department of Health will post the following information on the portal: Name of the manufacturer; name of the person in charge of the production facility's expertise; except for the production process and quality control process, the medical equipment that the business manufactures; location, contact phone number, and declaration of eligibility for production.

The above information is about the " Procedures for announcing the eligibility to manufacture medical equipment for the enterprise". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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