Slovakia
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Slovakia, Devices are regulated by the State Institute for Drug Control (ŠÚKL), Medical Devices Section. CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. TIMEFRAME: The EU registration process takes about 4-6 weeks after submission for Class I…
Lithuania
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Lithuania, devices are regulated by the Lithuanian State Health Care Accreditation Agency (VASPVT). CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the…
Spain
REGULATORY AUTHORITY: Devices are regulated by the Spanish Agency of Medicines and Health Products (AEMPS). CLASSIFICATION SYSTEM: Medical devices are classified according to the EU risk based classification system. Medical Devices: Class I, IIa, IIb, III. IVD Devices: List A & B annex II, Self testing IVD, all others. TIMEFRAME: Class I registration is not required. The notification process,…
United Kingdom
REGULATORY AUTHORITY: Medical devices in the UK are regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA). CLASSIFICATION SYSTEM: Medical devices: Classified according to risk into Classes I, IIa, IIb, and III. IVD Devices: Same as the EU IVDD– List A & B, Self testing, all others TIMEFRAME: The registration process takes about 6…
Moldova
REGULATORY AUTHORITY: Medical devices are regulated by the Medicines and Medical Devices Agency of the Republic of Moldova. CLASSIFICATION SYSTEM: Devices are classified according to the risk-based EU model of Classes I, IIa, IIb, III, and IV. TIMEFRAME: The approval process takes 45 days for Class I devices, and 90 days for all other classes of devices. LICENSE…
Poland
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. The Polish Ministry of Health (MOH) must also be notified of all medical and IVD devices which are marketed in Poland. CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, and III. TIMEFRAME: The registration process takes about 4-6 weeks…
Netherlands
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In the Netherlands, devices are regulated by the Ministry of Health, Welfare and Sport Agency, CIBG Farmatec. CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I…
Slovenia
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Slovenia, devices are regulated by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. TIMEFRAME: The registration process takes about 4-6 weeks after submission…
Portugal
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Portugal, devices are regulated by the National Authority of Medicines and Health Products, I.P.(Infarmed). CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For…
Iceland
REGULATORY AUTHORITY: Medical devices are regulated by the Icelandic Medicines Agency (IMA). Although Iceland is not a member of the European Union (EU), it is a signatory to the European Economic Area agreement. Devices can only be marketed and sold in Iceland if they already have a CE Mark. CLASSIFICATION SYSTEM: Medical devices are classified according to…
Belarus
Regulatory Authority: Department of Medical Equipment of Center for Examinations and Tests in Health Service (NCE) that working under Ministry of Health (MoH). Classification System: Medical Device and IVD: I/IIa/IIb/III Timeframe: According to our experience the whole registration process will takes around 3 months for medical device and 5 months for medical equipment. Special Requirements:…