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?
- 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:
Hotline: (+84) 911.233.955 - (024) 6293 8326
Doanh Tri Law Firm is pleased to accompany our Customers!
- APPLICATION FOR REGISTRATION OF CIRCULATION OF PROBIOTICS
- HOW TO RE-ISSUE THE REGISTRATION NUMBER FOR DAMAGED MEDICAL EQUIPMENT?
- PROCEDURES FOR REGISTRATION OF BIO - PRODUCTS IN 2021
- PROCEDURES FOR ISSUING NEW REGISTRATION NUMBER OF FREE SALE OF MEDICAL EQUIPMENT DO NOT YET HAVE RELEVANT NATIONAL TECHNICAL REGULATIONS
- PROCEDURES FOR NEW ISSUANCE OF FREE SALE NUMBER OF MEDICAL EQUIPMENT ALREADY HAVE RESPECTIVE NATIONAL TECHNICAL REGULATIONS
- HOW TO RENEW MEDICAL EQUIPMENT IMPORT PERMIT
- MEDICAL CERTIFICATION (HC) FOR FOOD, FOOD ADDITIVES, PROCESSING AIDS; TOOLS, FOOD PACKAGING MATERIALS AND CONTAINERS
- PROCEDURES FOR GRANTING CERTIFICATES OF SATISFACTION OF FOOD SAFETY REQUIREMENTS TO FOOD MANUFACTURERS AND TRADERS UNDER THE AUTHORITY OF THE MINISTRY OF HEALTH
- CERTIFICATE OF FREE SALE (CFS) FOR EXPORTED FOOD PRODUCTS
- HOW TO EXTEND THE CIRCULATION NUMBER OF MEDICAL EQUIPMENT?
- CONSULTING SERVICE FOR THE ANNOUNCEMENT AND CERTIFICATION OF MICROBIOLOGICAL PRODUCTS IN VIETNAM
- THE PROCESS OF CHEMICAL DECLARATION AND REGISTRATION IN VIETNAM
- CONSULTING REGISTRATION OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE IN VIETNAM