Manufacturing medical equipment is a conditional business line according to the provisions of Vietnamese law. Organizations and individuals must meet the conditions prescribed by law to set up medical equipment manufacturing company. The conditions, dossiers, procedures for setting up a medical equipment manufacturing company are analyzed in the following article.
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1. Conditions on professional managers of medical equipment manufacturing company
Persons in charge of professional qualifications possessing a college degree in medical equipment or higher or a bachelor’s degree in engineering or in medicine or pharmacy or higher;
For an establishment manufacturing medical equipment containing narcotic substances and precursors, this individual must have a bachelor’s degree in medical, medical, pharmaceutical, chemical or biological equipment;
Working directly on the technical equipment of medical equipment at medical equipment facilities from 24 months or more.
2. Production facility of medical equipment manufacturing company
– The location, area and factory are in accordance with the requirements of the type of medical equipment that the company manufactures.
– Equipment and manufacturing processes, quality control consistent with the requirements of the type of medical equipment that the company manufactures. In case there is no quality control equipment, it is required to have a contract with a competent testing unit to check the quality of the medical equipment it manufactures.
– Storage warehouses meet the following minimum conditions:
+ Area suitable to the type and quantity of medical equipment stored;
+ Ensure airy, dry, clean, not near sources of pollution;
+ Meet other preservation requirements of medical equipment according to the instructions for use.
– Have a means of transporting medical equipment or have a contract with the unit that meets the requirements for storage and transportation of medical equipment.
– Achieving ISO 9001 quality management system standard before January 1, 2018 and ISO 13485 quality management system before January 1, 2020.
– For medical equipment manufacturing company containing narcotic substances and precursors, it is necessary to have a monitoring system for management of the process of export, import, inventory and use of narcotic substances and precursors.
3. Steps to establish a medical equipment manufacturing company
3.1 Register for issuance of a business registration certificate (ERC)
Dossier of establishment of an enterprise granting enterprise registration certificate
– Application form for enterprise registration;
– Company rules;
– List of members for two-member limited liability companies or founding shareholders for joint stock companies;
– Certified copy of papers:
+ Citizenship identification cards, identity cards, passports of individual members;
+ Establishment decision, enterprise registration certificate of the organization and authorization document;
Agency authorized to deal with: Department of Planning and Investment where the medical equipment manufacturing company is headquartered.
Time: 5-7 working days from the date of receipt of complete and valid file
Results: The certificate of business registration involves the production of medical equipment
Note: in case a medical equipment manufacturing company locates a factory other than its head office, it must register its business location for the factory.
3.2. Registration for issuance of medical mask production license
After obtaining the business registration certificate, in order to be able to produce medical masks, medical equipment manufacturing company must have the following licenses:
– ISO certification;
– Testing of medical masks;
– Announcing the establishment which fully meets the conditions of producing masks;
– Classification of medical equipment.
Agency authorized to handle: Department of Health where medical equipment manufacturing company is located in the factory.
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