United Kingdom Product Registration & Certification
Important Notes
- UKCA Marking Transition Period: Post-Brexit implementation of UKCA system; CE marking still recognized during transition period (until December 31, 2024)
- MHRA Registration Requirements: All medical devices must register with UK Medicines and Healthcare products Regulatory Agency (MHRA) with different timelines by class
- Legal Representative Responsibility: Medical devices must appoint UK-based Responsible Person; cosmetics need UK-based Responsible Person
- Food Supplement Compliance: Food supplements must comply with UK Food Standards Agency (FSA) requirements including ingredient safety and claim management
- Technical Documentation Retention: Technical files must be retained at least 5 years after production discontinuation for MHRA review
- Post-market Surveillance System: Must establish UK-specific PMS and vigilance system reporting adverse events to MHRA
- UK MDR Regulation: Medical devices must comply with UK Medical Devices Regulations 2002 with technical documentation meeting UK standards
- Labeling Requirements: Product labels require UKCA marking, UK Responsible Person information, and English instructions with clear safety information
United Kingdom specific Requirements
- Post-Brexit Independent Regulatory System: Establishes independent UKCA certification system gradually separating from EU CE system
- MHRA-led Registration: Medical devices register with MHRA with differentiated timelines by risk classification
- UK MDR Regulatory Framework: Medical devices follow UK Medical Devices Regulations 2002 supplemented with post-Brexit requirements
- Cosmetic UK Procedures: Cosmetics require UK-specific notification procedures appointing UK-based Responsible Person
- Food Supplement FSA Oversight: Food supplements regulated by FSA requiring UK-specific ingredient and claim compliance
- Responsible Person System: Must appoint UK-based Authorized Representative or Responsible Person as legal entity
- Technical Documentation Localization: Technical documentation and labeling must meet UK-specific requirements including language and format standards
- Transition Period Management: Implements dual CE/UKCA recognition during transition requiring corporate compliance strategies
Medical Devices Registration
Regulatory Requirements
- UKCA marking or CE marking (recognized during transition period)
- Classification according to UK MDR 2002 (Class I, IIa, IIb, III)
- Technical documentation and clinical evaluation reports
- Quality management system compliance
- Declaration of Conformity (DoC)
- MHRA registration
Main Process
- Product classification determination
- Technical documentation preparation
- Conformity assessment completion
- MHRA registration submission
- UKCA/CE marking application
Registration Timeline
6-18 months
Official Fees
£2,000 - £35,000
Service Fees
$15,000 - $50,000
Regulatory System Overview
MHRA
Medicines and Healthcare products Regulatory Agency
Responsible for medical devices and medicines registration, quality supervision, and market surveillance, operating under the UK Department of Health
FSA
Food Standards Agency
Responsible for food and food supplements safety regulation and market surveillance, ensuring safety and compliance throughout the food supply chain
Medical Devices Registration Process
Product Classification
Determine medical device risk classification according to UK MDR 2002
Technical Documentation
Prepare technical documentation and clinical evaluation reports
Conformity Assessment
Complete assessment through UK Approved Body or CE recognized body
MHRA Registration
Submit medical device registration to MHRA
Marking Application
Apply UKCA marking or CE marking (UK recognized)
Cosmetics Registration
Regulatory Requirements
- UK Cosmetic Product Notification
- Product Information File (PIF)
- Safety Assessment Report
- Good Manufacturing Practice (GMP)
- UK labeling and packaging requirements
Main Process
- Safety assessment completion
- Product information file preparation
- UK notification submission
- GMP system establishment
- UK Responsible Person designation
Registration Timeline
2-4 months
Official Fees
£0 - £2,000
Service Fees
$4,000 - $12,000
Regulatory System Overview
MHRA
Medicines and Healthcare products Regulatory Agency
Responsible for medical devices and medicines registration, quality supervision, and market surveillance, operating under the UK Department of Health
FSA
Food Standards Agency
Responsible for food and food supplements safety regulation and market surveillance, ensuring safety and compliance throughout the food supply chain
Cosmetics Registration Process
Safety Assessment
Complete product safety assessment by qualified safety assessor
PIF Preparation
Prepare complete Product Information File
UK Notification
Submit product information through UK Cosmetic Product Notification Portal
Responsible Person
Designate UK-based responsible person
Labeling Compliance
Ensure labeling meets UK requirements
Food Supplements Registration
Regulatory Requirements
- UK Food Standards Agency (FSA) compliance
- Ingredient compliance assessment
- Nutrition and health claims compliance
- Good Manufacturing Practice certification
- UK labeling and advertising requirements
Main Process
- Ingredient compliance assessment
- Technical documentation preparation
- FSA compliance confirmation
- Labeling review completion
- Post-market surveillance establishment
Registration Timeline
3-6 months
Official Fees
£500 - £5,000
Service Fees
$6,000 - $15,000
Regulatory System Overview
MHRA
Medicines and Healthcare products Regulatory Agency
Responsible for medical devices and medicines registration, quality supervision, and market surveillance, operating under the UK Department of Health
FSA
Food Standards Agency
Responsible for food and food supplements safety regulation and market surveillance, ensuring safety and compliance throughout the food supply chain
Food Supplements Registration Process
Ingredient Compliance
Assess ingredients against UK permitted lists
Technical Documentation
Prepare product formulation and safety evidence
FSA Compliance
Ensure product meets FSA requirements
Labeling Review
Ensure labeling complies with UK requirements
Post-market Surveillance
Monitor regulatory changes and product compliance