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,…
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…
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Lithuania, the responsible authority is The State Health Care Accreditation Agency (VASPVT) CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification. Medical Devices: Class I (low), IIa, IIb, III (High) IVD Devices: A (Low),B,C,D (high) TIMEFRAME: The registration process takes about 4-6…
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In the Netherlands, the responsible authority is Dutch Health and Youth Care Inspectorate (IGJ) CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification. Medical Devices: Class I (low), IIa, IIb, III (High) IVD Devices: A (Low),B,C,D (high) TIMEFRAME: The registration process takes about…
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Poland, the responsible authority is Office for Registration of Medicinal Products, Medical Devices and Biocidal Products CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification. Medical Devices: Class I (low), IIa, IIb, III (High) IVD Devices: A (Low),B,C,D (high) TIMEFRAME: The…
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Portugal, the responsible authority is Infarmed – National Authority of Medicines and Health Products CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification. Medical Devices: Class I (low), IIa, IIb, III (High) IVD Devices: A (Low),B,C,D (high) TIMEFRAME: The registration process takes…
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Slovakia, the responsible authority is State Institute for Drug Control, Medical Devices Section (SUKL) CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification. Medical Devices: Class I (low), IIa, IIb, III (High) IVD Devices: A (Low),B,C,D (high) TIMEFRAME: The registration process takes…
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Slovenia, the responsible authority is Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification. Medical Devices: Class I (low), IIa, IIb, III (High) IVD Devices: A (Low),B,C,D (high)…
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,…
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…
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:…
