Health Hazard Evaluation

Health Hazard Evaluation Overview

Health hazard evaluation form is crucial for accessing potential risks associated with medical devices. It helps Regulatory bodies and manufacturers determine the severity of the hazards and take appropriate corrective actions to resolve them.

The key components of completing a HHE form are -

Risk Assessment – Identifies potential health risks linked to defective or malfunctioning products
Regulatory Compliance – Ensures adherence to stands like FDA, EU MDR
Recall Management – Supports decision-making in product recalls by evaluating the impact on public health

Health Hazard Evaluation Services

Data Collection and Analysis
Gather information on affected products, including complaints, adverse events, and failure rates.
Risk Assessment
Evaluate the severity of health consequences.
Regulatory Compliance
Ensure adherence to FDA, EU MDR, and ISO 13485 standards for recall classification and risk mitigation.

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

Medicinal Products Regulatory Services

Medical Devices Regulatory Services

Cosmetics Regulatory Services

Food Supplements Regulatory Services

Food Product Service

Food Product Compliance

Novel Food Registration

Chemicals Regulatory Services

Medicinal Products Regulatory Services

Medical Devices Regulatory Services

Consumers

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Health Hazard Evaluation

Health Hazard Evaluation Overview

Health Hazard Evaluation Services

Data Collection and Analysis

Risk Assessment

Regulatory Compliance

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