The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed amendments aim to modify a wide scope of provisions and cover numerous aspects related to the regulation of medical device circulation.
General Provisions and Main Principles
The first concept the amendments introduce is a modified definition of a medical device. This definition was harmonized substantially with the definition used in EU legislation. This definition includes all types of medical devices used both individually or in combination with each other, e.g. in vitro diagnostic devices, disinfecting equipment, measuring and monitoring devices. The decree also says that entities operating with medical devices containing drugs or chemicals must also comply with the appropriate regulations.
According to the amendments, the risk-based medical device classification includes 2 groups and 4 types, namely:
– Group 1, including Type A medical devices,
– Group 2, including Type B (low risk), Type C (moderate risk) and Type D (high risk) medical devices.
The amendments also introduce the classification rule providing that the classification should be based on the risk associated with the device and should be performed by the designated establishment. If a medical device meets the criteria of two or more levels of risk, the highest one should be applied. The same principle should be applied if the device has several intended purposes. If the device is intended to be used in connection with other medical equipment, each device should have its own classification while the overall risk of the group should be defined according to the highest risk among all devices of the group. The Ministry of Healthcare specifically emphasizes the importance of the classification to comply with international rules and principles. If there are any discrepancies related to classification, the final decision should be made by the Ministry.
The decree also implements rules for obtaining practice certificates. According to these rules, a professional who is going to perform medical device classification should have a university degree in engineering or medicine, at least 24 months of relevant experience within 48 months prior to applying for the certificate, and should have also completed the courses organized by the Ministry of Healthcare. To apply for the certificate, an applicant must file a written request accompanied by the documents defined in the decree. The document also provides the procedures of modification of content and adjustments to the practice certificates. To be eligible to classify medical devices, the establishment must employ at least 1 professional with a valid classification practice certificate. In this case, the establishment should then submit the Declaration of eligibility to confirm compliance with the appropriate regulations while the Ministry of Healthcare should approve eligibility.
Registration of a Medical Device in Vietnam
Any establishment, either a domestic medical device manufacturer or importer of a foreign medical device, should register the device and obtain the circulation number. According to the regulation, the circulation number will be issued in the following cases:
- When the device is being registered for the first time,
- Any changes are made to the device or raw materials used, requiring re-issue of the circulation number,
- Other cases provided by the legislation.
The decree also provides the requirements that allow the issue of a circulation number in the case of an accelerated procedure. Such a procedure could be applied if:
– The device is already registered and approved for circulation in at least 2 countries from this list: Japan, Canada, Australia, USA, EU member states, or
– Has been in circulation in Vietnam before December 31, 2018, for at least 3 years within 5 years prior to submission and there is no warning information regarding its safety or quality.
To apply for the issuance of a new circulation number for the medical device, the establishment must submit a written request accompanied by the following documents:
– Classification of medical device,
– A valid certificate of quality management standard,
– Authorization letter of the owner of the device (if provided by another party),
– Certificate of eligibility for warranty issued by the owner (if applicable),
– Certificate of free sale,
– Documents describing the technical summary of the medical device,
– General technical dossier of the medical device,
– Documentation of the use of the medical device,
– Summary of clinical trial data (for Type C and Type D medical devices penetrating the human body),
– Sample of labels to be used on the Vietnamese market,
– Proclamation of production conditions,
– Report on the results of business activity.
All documents issued in languages other than Vietnamese should be provided with an appropriate translation.
Obligations of Establishments
The decree also amends the obligations the manufacturers and other establishments involved in operations with medical devices should abide by. The list of obligations includes, but is not limited to the following:
- Registration. To be able to distribute a medical device, the manufacturer of the importer should obtain the circulation number that is a national analog to the unique identification number used to track the device on all steps of its lifecycle. This number could also be used by the regulating authority to require the withdrawal of the device in certain cases prescribed by the law.
- Quality control. The manufacturer must establish a tracking system covering all processes including operations with raw materials, manufacturing, importing, exporting, and storing. It is important to notice that all operations with drugs as components of medical devices should be subject to separate tracking. Before producing medical devices, the manufacturer must file the appropriate dossier to the Ministry of Healthcare to confirm the eligibility for manufacturing medical devices. The manufacturer is also obliged to notify the regulating authority in case of change of the person responsible for quality control or the address of producing facilities.
- Special requirements. If medical devices are being provided to healthcare facilities, the establishment shall keep records containing the information on the number of medical devices supplied, their names, types and circulation numbers.
- Change notification. During the lifecycle of a medical device, the holder of the circulation number (the establishment that performed the registration of a medical device) must promptly notify the regulating authority on any changes related to:
- The name of the circulation number holder,
- The name of the manufacturer,
- Packaging and labeling,
- Warranty facility responsible for post-marketing maintenance and service.
- Investigation and corrective actions. The circulation code owner should notify the Ministry of Healthcare on any investigation that takes more than 30 days stating the cause and solutions proposed. If the medical device could be defined as one with errors and defects that could affect a patient’s health, depending on the particular situation and level of risk associated with the use of the device it may be required to:
- Temporarily suspend the circulation of the device, or
- Notify all parties involved on potential adverse effects, or
- Create a plan to fix errors or recall defective devices,
- Report to the Ministry of Healthcare about actions taken and their outcomes.
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