Understanding Medical Device Registration and Vigilant System in Norway
Norwegian Medicines Agency
The Norwegian Medicines Agency (NOMA) is a government agency under the Ministry of Health and Care Services, tasked with ensuring public and animal health by ensuring the safety, quality, and efficacy of medicines and enforcing medical device regulations.
Their tasks include assessing medicines, administering the pharmaceutical distribution chain, determining prescription medicine prices, and evaluating cost effectiveness. They also supervise clinical trials, marketing, and safety deficiencies. NOMA also provides medical information, regulations, and advice to doctors and the general public.
They also manage medical devices legislation, monitor the market, and participate in international cooperation.
NOMA also represents Norway in EU scientific committees and working parties, participates in European co-operation, and makes assessments of medicines on behalf of the European Medicines Agency.
https://legemiddelverket.no/english
EU MDR 2017/745
Class I, IIa, IIb and III
The registration process takes approximately the same time as in the EU
5 years
Norwegian labeling and IFU
Incidents with medical devices on the market related to accidents and failures defined as serious incidents must to be reported to the Norwegian Medical Products Agency.
Incidents involving medical devices refer to any malfunction or deterioration in the properties or performance of the device.
This also includes:
A serious incident is defined as any event that has directly or indirectly led to, could have led to, or may lead to any of the following:
Serious incidents involving medical devices in the Norwegian market must be reported to the Norwegian Medical Products Agency (NoMA)
Healthcare facilities are obligated to report serious incidents that are or may be related to the use of a medical device.
Classification of incident |
Deadline |
Serious threat to public health |
2 days |
Death |
10 days |
Unexpected serious deterioration of a person’s health condition |
10 days |
Other serious incidents |
30 days |
The manufacturer can submit a combined preliminary and final report if they have all the necessary information to complete within deadlines. If an incident cannot be determined, it should be reported within the deadline. The manufacturer can submit an incomplete preliminary report and then a complete report after obtaining all necessary information and completing the investigation.
A field safety corrective action is an action that manufacturers can implement based on technical or medical reasons to prevent or reduce the risk of serious incidents when using a medical device that has been placed on the market.
The Norwegian Medical Products Agency is responsible for ensuring that manufacturers implement field safety corrective actions as planned. The agency assesses received reports and monitors their implementation, evaluating the sufficiency of the manufacturer’s measures and determining if additional corrective measures are needed. The agency collaborates with other EU authorities to monitor these actions. When a Norwegian manufacturer reports a safety corrective action, the information is shared with the European network, ensuring other authorities in the countries where the medical device is on the market are informed, in addition to the manufacturer’s own notification.
Before placing a medical device into the market.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.