Understanding Medical Device Registration and Vigilant System in Romania

Regulatory Authority

National Agency for Medicines and Medical Devices

The National Agency for Medicines and Medical Devices (NAMMD) is a public institution established in Romania by Government Decision No. 734 of 21 July 2010. Its mission is to protect and promote public health by evaluating documentation for authorization, monitoring the safety of medicinal products for therapeutic use, ensuring access to accurate information, maintaining high performance and safety of medical devices, assessing medical-technical units, issuing technical procedures, and ensuring institutional administrative effectiveness.

The NAMMD aims to strengthen its status as a reference national authority and a reliable source of accurate information. Its strategic objectives include protecting public health, providing clear and timely information, contributing to the projection of future legal frameworks, and coordinating a quality and qualified workforce to cope with future challenges.

Link for Regulatory Authority

https://www.anm.ro/en/dispozitive-medicale/inregistrare-dispozitive-medicale-in-baza-nationala-de-date/

Local Regulation

• Decision No. 54/2009 (29 Jan. 2009)
• Decision No. 798/2003 – on IVDs
• Decision No. 344/2004 – on active implantable devices

Classification of Medical Device

Class I, IIa, IIb and III

Overview on Medical Device Registration

The manufacturer or the authorized representative of the manufacturer, based in Romania, has the obligation to register with the NAMMDR in accordance with the provisions of Article 6 of Order of the Minister of Health no. 3539 of 2022 on approval of the Methodological Rules regarding the introduction of medical devices on the market and the registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database and exemption from the procedures for assessment of compliance, when placing the following types of medical devices on the market:

1. Class I, IIa, IIb and III medical devices, including sterile and / or measuring devices;
2. Systems and procedure packages referred to in Article 22 of the Regulation;
3. Custom-made active implantable medical devices

 Form F1 – Notification form for the introduction of medical devices on the market

Listing or Registration Requirements

• On market placement of the following types of medical devices, NAMMD registration of manufacturers, or their authorized representatives established in Romania, is mandatory: Class I medical devices, including sterile and / or measuring devices; Custom-made medical devices and custom-made active implantable medical devices; Systems and procedure packages & In-vitro diagnostic medical devices.
• In Romania, NAMMD notification by manufacturers, their authorized representative, importers, or distributors established in Romania/other Member State is mandatory when placing into service the following types of medical devices (within 3 months):
  • Class IIa, IIb and III medical devices;
  • In-vitro diagnostic medical devices covered by Annex II
  • In-vitro diagnostic medical devices for self-testing;
  • Active implantable medical devices.

Documents Required

1. Certified copy of the registration certificate or other official document / normative document certifying the establishment of the requesting unit and the ascertaining certificate issued by the registry office trade from which the object of activity of the company results, for the requesting units that have the obligation to register at the trade register office the establishment of the requesting unit.
2. The EC declaration of conformity of the manufacturer provided in Annex no. 7 to the Government Decision 54/2009, with the subsequent amendments.
3. The declaration of conformity provided in annex no. 8 to the Government Decision 54/2009, with the subsequent modifications ÿ the declaration of conformity provided in art. 29 of the Government Decision No. 54/2009, with subsequent amendments.
4. A list of the components of the system or package of procedures, together with the EC declaration of conformity of the manufacturer for each component.
5. Technical specification.
6. Instructions for use of the medical device.
7. Medical device label
8. The declaration of conformity provided in annex no. 6 to the Government Decision 55/2009, with subsequent amendments
9. The document by which the manufacturer designates you as an authorized representative
10. Copy of the certificate of conformity issued by a notified body

Registration Timeline

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

Registration Fee

No Fees

License Validity

5 Years

Special Labelling Requirements

The information provided by the manufacturer together with the medical device must be in the Romanian language

Vigilance

The medical devices vigilance system is a system for reporting and evaluating incidents and field safety corrective actions (FSCA). This system is primarily aimed at the health and safety of patients, users, and others by reducing the likelihood of an incident occurring again at another location. 

This is done by evaluating reported incidents and, where appropriate, disseminating information which could be used to prevent the recurrence or mitigate the consequences of such incidents.

According to the requirements set out in Articles 13 and 14 of the MDR, if an importer or a distributor based in Romania considers or has reason to believe that a device is exposed to a serious risk or is a counterfeit device, it must inform the NAMMDR about this. If the device in question is also available in other EU member states, the distributor or importer must inform the competent authorities in the affected markets about the potentially serious risk or about the counterfeit device.

CORRECTIVE ACTION REPORT ON SAFETY IN OPERATION

Field safety corrective action is a corrective action taken by a manufacturer, for technical or medical reasons, to prevent or reduce the risk of an incident occurring in relation to a medical device made available on the market. Field Safety Corrective Actions are brought to the attention of the Competent Authorities via the Field Safety Corrective Action (FSCA) form.

Field safety corrective actions may consist of changes to the medical device, recommendations provided by the manufacturer regarding the use of the device and/or tracking of patients, users, etc. or returning a medical device to suppliers. Manufacturers bring field safety corrective actions to the attention of operators/users through Field Safety Notifications (FSN).

• Reporting form – Incidents related to medical devices – Users
• Reporting form – Incidents related to medical devices – Manufacturers

Additional Comments

On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

On market placement of the following types of medical devices, NAMMD registration of manufacturers, or their authorized representatives established in Romania, is mandatory: Class I medical devices, including sterile and / or measuring devices; Custom-made medical devices and custom-made active implantable medical devices; Systems and procedure packages & In-vitro diagnostic medical devices.

In Romania, NAMMD notification by manufacturers, their authorized representative, importers, or distributors established in Romania/other Member State is mandatory when placing into service the following types of medical devices:

• Class IIa, IIb and III medical devices;
• In-vitro diagnostic medical devices covered by Annex II
• In-vitro diagnostic medical devices for self-testing;
• Active implantable medical devices. 

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk