GAP Analysis

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Product GAP Analysis

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP provides comprehensive global regulatory affairs services, leveraging our expertise to navigate market-specific regulations and ensure your products are safe, effective, and compliant with both local and international standards, enabling seamless export and distribution.

Product GAP Analysis: Essential Insights for Your Business

GAP analysis is a comprehensive service that examines global regulations to assess how well your product meets the requirements of its target markets.

We provide a clear roadmap to help clients prepare their products for launch in compliance with relevant regulations. Ultimately, GAP analysis minimizes regulatory risks in global markets and serves as a critical first step toward successful product commercialization.

KGMP Product GAP Analysis Service

Product Information Review	Category Analysis	Regulatory Compliance Advisory	1:1 Customized Consulting

Key Stage of Product GAP Analysis

Product classifications differ by country and depend on the intended use and relevant factors according to the target market's regulations. A thorough analysis of product definitions and applicable categories is essential to ensure regulatory compliance.

This analysis covers product definitions and the classification of applicable categories in each country, with a focus on ensuring regulatory compliance. Accurate classification is a crucial key for successful market entry.

Definition & Classification of Food and Dietary Supplement

Food products can be classified differently depending on the country, with examples of regulated terms including general foods, health supplements, health functional foods, specially controlled foods, standardized foods, and natural products.

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• Food: General Foods & Conventional Foods (e.g., Bread, Beverages, Meat, Liquors, Sauces, etc.)
• Dietary Supplement (or Health Functional Food): A product intended for ingestion that contains dietary ingredients (functional ingredients) such as vitamins, minerals, herbs (or other botanicals), amino acids, etc.
• Infant Formula: A food specifically designed to be the sole source of nutrition for infants (children up to 12 months of age) as an alternative to human milk.
• Medical Food: A specially formulated food intended for consumption or administration enterally under the supervision of a physician, designed for the specific dietary management of a disease or condition with distinct nutritional requirements established through medical evaluation.

Note: Product classification systems and definitions differ by country, with distinct laws and regulations for each product type. Contact us for precise regulatory insights.

Definition & Classification of Cosmetic

Cosmetic products can be classified differently across countries, using regulated terms like general cosmetics, functional cosmetics, OTC, and personal care products. A product classified as a functional cosmetic in one country may be considered a drug in another.

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• Cosmetic: Products applied to the human body for cleansing, beautifying, enhancing attractiveness, or altering appearance. Examples include moisturizers, perfumes, makeup, hair colors, and deodorants.
• Functional Cosmetic: Cosmetics with specific functions, such as improving skin or hair conditions. Examples include products for skin whitening, wrinkle improvement, acne relief, hair loss prevention, and body hair removal.
• Drug: Products intended for diagnosing, curing, mitigating, treating, or preventing disease, or affecting body structure or function, excluding food.
• Personal care: Consumer products applied to external body parts (skin, hair, nails, lips, etc.) or oral areas to clean, protect, or maintain them in good condition.

Note: Product classification systems and definitions differ by country, with distinct laws and regulations for each product type. Contact us for precise regulatory insights.

Definition & Classification of Medical Device

The medical device classification system categorizes devices based on their risk level and characteristics, serving a crucial function in their registration, documentation, quality management, and applicable regulatory scope.

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Medical devices are generally classified into three or four classes based on their risk level. Each class has different regulatory requirements and registration procedures:

• Class I: Low-risk devices that are subject to general regulatory requirements. Examples include hand sanitizers and adhesive bandages.
• Class II: Medium-risk devices that require performance validation and must meet specific standards. Examples include blood pressure monitors and glucose meters for diabetes management.
• Class III: High-risk devices that perform critical functions or sustain life, requiring rigorous clinical trials and safety evaluations. Examples include pacemakers and implantable defibrillators.

Note: Product classification systems and definitions differ by country, with distinct laws and regulations for each product type. Contact us for precise regulatory insights.

Definition & Classification of Drug and OTC

Drug classification is a systematic method of categorizing drugs based on criteria such as therapeutic use, mechanism of action, chemical structure, or legal status, and is crucial as it impacts prescribing practices and pharmaceutical regulation.

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• Over-the-Counter (OTC) Drugs: Medications that can be purchased without a prescription, intended for self-medication of minor conditions.
• Prescription Drugs: Medications that require a prescription from a licensed healthcare professional due to their potential risks, side effects, or intended uses.
• Herbal and Traditional Medicines: Products derived from plants or natural sources used for medicinal purposes, often with historical or cultural significance.
• Biologics: Products derived from living organisms, such as vaccines, blood products, and gene therapies.
• Generic Drugs: Drugs that are bioequivalent to branded prescription drugs but sold under their chemical name.
• New Drugs: Medications that have not previously been marketed or sold in a given country and require approval from regulatory authorities before they can be prescribed or sold.

Note: Product classification systems and definitions differ by country, with distinct laws and regulations for each product type. Contact us for precise regulatory insights.

Definition & Classification of Pesticide and Cleaner

Pesticides and cleaners are categorized to ensure safe use and proper regulation. This classification is based on chemical composition, intended use, and potential health and environmental risks.

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• Pesticide: Any substance or mixture designed to prevent, destroy, repel, or mitigate pests. This includes substances used as plant regulators, defoliants, desiccants, or nitrogen stabilizers.
• Pesticide device: Any instrument or contrivance (excluding firearms) intended for trapping, destroying, repelling, or mitigating pests or other forms of plant or animal life (excluding humans and microorganisms). This definition does not include equipment sold separately for pesticide application.
• Disinfecting: A chemical agent specifically designed to kill viruses and bacteria on surfaces.
• Sterilizer: A chemical agent used to sanitize surfaces by killing bacteria. Note that it is not intended to eliminate viruses.
• Cleaner: A product used to remove dirt and organic matter from surfaces, typically utilizing soap or detergents.

Note: Product classification systems and definitions differ by country, with distinct laws and regulations for each product type. Contact us for precise regulatory insights.

Remember that different regulations apply in each country.

Contact us today to discover how our Procuct GAP Analysis services can benefit your business.

KGMP simplifies compliance with complex global regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final products.

U.S. FDA Compliance	Health CANADA Compliance	MFDS Compliance
EU & UK Compliance	ASEAN Compliance	NMPA Compliance

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

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