CONDITIONS FOR MEDICAL EQUIPMENT MANUFACTURE

Given the direct impact of the finished product on human health and life, the manufacture of medical equipment is categorized as one of the industries with stringent conditions for operation. Individuals and organizations operating in this field are required to fully comply with the legal requirements to obtain licenses and operate lawfully. So, what are the specific business conditions for medical equipment manufacture?

1. What is medical equipment?

As defined in Decree No. 98/2021/ND-CP, medical equipment encompasses various types of devices, grafting materials, instruments, materials, test kits, in vitro diagnostic reagents, software fulfilling the following criteria:

a. To be used either individually or in combination as instructed by the owner of the medical equipment to serve one or multiple purposes for humans, including:

– Diagnosis, prevention, monitoring, treatment, and alleviation of diseases or injuries;

– Examination, replacement, adjustment, or support for anatomy and physiological processes;

– Support or maintenance of life;

– Birth control;

– Disinfection of medical equipment;

– Provision of information for diagnosis, monitoring, and treatment through testing specimens originating from the human body.

b. Not to be involved pharmacological, immunological, or metabolic mechanisms within or on the human body. If these mechanisms are used, they serve solely as supportive means to achieve the purposes specified in point a above.

2. Quality management requirements for medical equipment manufacture facilities

The facilities must meet the ISO 13485 quality management system standards.

Additionally, medical equipment manufacture facilities containing narcotics and precursor substances must fulfill the following additional requirements:

– Implement a monitoring system to manage the process of import, export, inventory, and use of narcotic and precursor substances, as well as the import, export, and inventory of medical equipment and materials containing narcotics and precursor substances.

– Medical equipment and materials containing narcotics and precursor substances must be stored in a separate area within the warehouse or in a separate warehouse to ensure safety.

>> DOSSIERS FOR ISSUANCE OF DOCTOR MEDICAL PRACTICE CERTIFICATE https://linconlaw.vn/dossiers-for-issuance-of-doctor-medical-practice-certificate/

3. Procedures to be followed

Medical equipment manufacture facilities need to complete the procedure for declaring their production capacity before commencing production activities.

– Step 1: The medical equipment manufacture facility submits the dossier to the Department of Health where the manufacturing location is situated (the manufacture location is determined by the address specified in the quality management system certificate). If there are multiple manufacture locations in different provinces, the declaration must be made separately for each province.

– Step 2: The competent authority receives the dossier and the medical equipment manufacture facilities pay the required fees as stipulated.

– Step 3: The authority processes the dossier and publicly posts it on the Electronic Information Portal for the management of medical equipment, including all relevant information and documents concerning the declaration of production capacity for medical equipment.

Note: During operations, the manufacture facility is responsible for notifying, making adjustments, and updating relevant documents regarding any changes that occur to the declared dossier within a period of 03 working days, starting from the date of the changes to the information in the declared dossier.