Pakistan

REGULATORY AUTHORITY: Drug Regulatory Authority of Pakistan (DRAP) – Medical Devices & Medical Cosmetics Division (MD&MC). CLASSIFICATION SYSTEM: Medical Devices and IVDs: A/B/C/D TIMEFRAME: New Registration: 3-6 months. SPECIAL REQUIREMENT: On-Site Audit: Manufacturing site inspection is sometimes required, especially for medical devices that were not previously approved by the USA, Japan, Australia, Canada, Austria, Belgium,…

Uganda

REGULATORY AUTHORITY: The National Drug Authority (NDA). REGULATORY STATUS: In Uganda, only Surgical instruments and appliances are regulated and need to be registered. All the information below applies to these devices. CLASSIFICATION SYSTEM Surgical instruments and appliances are classified according to risk into Classes A-D, with A being the lowest risk and D being the…

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…

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…

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…

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…

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…

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…

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…

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:…