Understanding the ALIMS Medical Device registration and Vigilant Post Market Surveillance in Serbia

Regulatory Authority

Medicines and Medical Devices Agency of Serbia (ALIMS)

Link for Regulatory Authority

https://www.alims.gov.rs/medicinska-sredstva/

Local Regulations

Law on Medicines and Medical Devices of Serbia

Overview on Serbia Medical Device Registration

The Serbian government has been regulating the marketing of medical devices since 1993, with the first regulation being based on the Law on the Production and Trade of Medicines. The new Law on Medical Devices was adopted in 2017, and its full implementation began at the end of 2018. ALIMS, the authority responsible for medical device registration, operates in electronic form, following the current regulations.

The company maintains the “Register of Medical Devices” with all relevant data related to medical devices registered in Serbia. It also registers foreign and domestic manufacturers of medical devices in the “Register of Manufacturers.” Registration is submitted on Form 1 with appropriate documentation and proof of payment, and the sale of registered medical devices is carried out based on a valid registration decision.

ALIMS can approve the circulation of unregistered medical devices only at the request of the import proponent, such as healthcare institutions, private practices, social welfare institutions, humanitarian organizations, patient associations, defense affairs ministries, and emergency situations ministries. It also issues approvals for clinical trials of medical devices and monitors their safety through vigilance and market surveillance.

ALIMS regularly publishes information on its official website about the “Register of medical devices”, “Register of manufacturers”, and “Register of authorized representatives of manufacturers of medical devices“.

Classification of Medical Device

Class I, IIa, IIb, III

Listing or Regulation Requirements

• The registration procedure in the Register of Medical Devices is different for medical devices with and without the CE-mark.
  • Medical devices with the CE-mark refer to the devices controlled in an institution accredited by the European Union and means that these medical devices are compliant with the EU directives on medical devices. Registration in the Register shall be performed by an administrative procedure based on relevant certificates and documents on compliance with the EU directives on medical devices.
  • Registration of medical devices without the CE-mark shall be performed based on the evaluation of performed quality, safety and efficiency tests which are conducted in our country, in accordance with internationally accepted standards.
• Issuance procedure for the Decision on registration of medical devices in the Register of Medical Devices is in accordance with the Guidelines of Good Regulatory Practice.

Documents Required for Registration

• Registration form
• Certificate of conformity – EC Certificate
• Declaration of Conformity
• Written authorization of the foreign manufacturer for the authorized representative of the manufacturer to act on his behalf and to conduct proceedings before the competent authorities of the Republic of Serbia

Registration Fee

• Class I: USD 118 (up to 25 products); USD 95 (26-100 products); USD 71 (more than 100 products)
• Class IIa: USD 294 (up to 25 products); USD 236 (26-100 products); USD 177 (more than 100 products)
• Class IIb: USD 353 (up to 25 products); USD 283 (more than 25 products)
• Class III: USD 589 (up to 15 products); USD 471 (more than 15 products)
• AIMD: USD 589 (up to 10 products); USD 471 (11-25 products); USD 353 (more than 25 products).

License Validity

The validity of the registration certificate will follow the validity of the certificate of conformity (plus 60 days after the expiry date), except for Class I medical devices (non-sterile, non-measuring) and other IVDs, the registration certificate will be valid for 5 years.

License Renewal

The request for approval must be submitted a maximum of 180 days before, and no later than 90 days after, the expiry of the marketing authorization.

Special Labelling Requirements

Medical devices must be labelled in the Serbian language. Serbian AR details may be indicated on label-not a mandatory requirement

Vigilance of Medical Devices

The Agency for Medicines and Medical Devices of Serbia, in accordance with the Law on Medical Devices (“Official Gazette of the RS” No. 105/2017) and the Rulebook on Vigilance (“Official Gazette of the RS”, No. 3/2019), organizes and monitors vigilance medical devices.

Medical device vigilance is a set of activities related to the collection, evaluation, understanding and response to knowledge about the risks arising from the use or application of a medical device, and especially with regard to reporting incidents (incidents) in order to improve and protect the health and safety of patients and users and other persons and if it is necessary to provide information that reduces the likelihood that the incident will be repeated in another place or that mitigates the consequences of that incident.

An incident is any malfunction or deterioration of the characteristics or performance of a medical device, as well as inadequacy in labeling or instructions for use.

The law mandates health institutions to appoint and report a vigilance coordinator to the Agency, who informs the Agency and the manufacturer about incidents after a medical device is released on the market. In June 2022, the Agency established a medical device vigilance system for coordinators, using an IT solution called ePortal MS for registration. Health workers, manufacturers, and users can also report adverse reactions via email or phone.

Reporting an adverse reaction to a medical device (INCIDENT)

• Adverse reaction to a medical device is reported by healthcare professionals using the Adverse Reaction Reporting Form
• Adverse reaction to a medical device is reported by registration holders and manufacturers via the Adverse Reaction Reporting Form
• An adverse reaction to a medical device is reported by manufacturers (FSCA) via the Field Safety Corrective Action Reporting Form

You can send the completed application

• to the e-mail address: vigilancams@alims.gov.rs
• to the postal address:
  Agency for Medicines and Medical Devices of Serbia
  (Sector for Medical Devices)
  Vojvode Stepe 458, 11221 Belgrade
  You can report an adverse reaction by phone via number: 011/3951-158

Post Market Surveillance

The surveillance of medical devices on the market involves post-market surveillance and market surveillance. This regulation is based on EU directives (98/79 EC, 93/42 EEC, 98/385 EEC) or new EU regulations (“(EU) 2017/745″/ “(EU) 2017/746”). Post-market surveillance involves manufacturers establishing and maintaining a systematic procedure for proactive collection and evaluation of experiences related to their medical devices placed on the market or in use. The purpose is to identify any need for corrective and preventive measures without delay.

Market surveillance involves activities carried out by the Ministry and the Agency for Medicines and Medical Devices of Serbia to ensure that medical devices comply with basic requirements and do not endanger health, safety, or general interest. 

Manufacturers are required to continuously monitor the market to identify any need for immediate corrective or preventive measures. They keep records of implemented corrective and preventive measures and report to the Agency.

The Agency provides, organizes, and coordinates the collection and analysis of data obtained after placing a medical device on the market. The Agency may require manufacturers to submit a reasoned and evidence-based report on the experiences of the medical device on the market. 

Two types of reports are submitted to the Agency: Post-Market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR). PMSR summarizes the results and conclusions of the analysis of post-marketing monitoring data collected as a result of the post-marketing monitoring plan, while PSUR summarizes the results and conclusions of the data analysis post-marketing monitoring collected as a result of the post-marketing monitoring plan.

Additional Comments

Changes following the implementation of the EU MDR must be anticipated:

Class I medical devices (sterile, have a measuring function or are reusable surgical instruments) whose conformity certificates were issued before May 26, 2021.

Certificates issued in accordance with the requirements of Directives 93/42/EEC and 90/385/ EEC shall remain valid until the date specified on the certificate but no later than May 26, 2024. 

https://www.alims.gov.rs/regulativa/medicinska-sredstva/uputstva/