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I'm a brand owner who private-labels cosmetic products manufactured by a third party. If I sell products under my own brand name, do I automatically become the Responsible Person, or can the manufactu...

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Asked: 5 months ago
Asked by Lo H. Khamis

I'm confused about the different roles in the EU cosmetics supply chain. What's the difference between the Responsible Person, importer, and distributor, and can the same company fulfill multiple role...

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Asked: 5 months ago
Asked by Lo H. Khamis

I'm considering using a virtual office or mail forwarding service for my EU Responsible Person address. Is this allowed under EU cosmetics regulations, and what are the practical considerations?

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Asked: 5 months ago
Asked by Lo H. Khamis

I'm preparing labels for my cosmetic products to sell in the EU. What are all the mandatory labeling requirements, including Responsible Person information, ingredients, warnings, and other required e...

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Asked: 5 months ago
Asked by Lo H. Khamis

I need to prepare for CPNP notification but want to understand what information I'll need to provide. What product details, documentation, and data must be included in the EU notification?

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Asked: 5 months ago
Asked by Lo H. Khamis

I understand CPNP is a centralized system, but I'm unclear if I still need to submit separate notifications to individual EU member states. Does CPNP cover all EU countries, or are there additional na...

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Asked: 5 months ago
Asked by Lo H. Khamis

I keep hearing about CPNP notifications. What is CPNP, is it mandatory, when do I need to notify, and what information must be submitted?

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Asked: 5 months ago
Asked by Lo H. Khamis

I'm confused about the Cosmetic Product Safety Report (CPSR). What is it, who creates it, who signs it, and what's the relationship between the CPSR and the Responsible Person?

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Asked: 5 months ago
Asked by Lo H. Khamis

I understand I need a Product Information File, but I'm unclear on retention requirements. How long must the PIF be maintained, where must it be stored, and what are the accessibility requirements?

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Asked: 5 months ago
Asked by Lo H. Khamis

I keep hearing about the Product Information File (PIF) requirement. What exactly is a PIF, what must be included in it, and why is it so important for EU cosmetics compliance?

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Asked: 5 months ago
Asked by Lo H. Khamis

I understand I need an EU Responsible Person, but I want to know exactly what they're responsible for. What are their day-to-day obligations and what happens if something goes wrong?

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Asked: 5 months ago
Asked by Lo H. Khamis

I'm a non-EU cosmetics brand selling directly to EU customers through my website. Do I still need an EU Responsible Person, or does this requirement only apply to physical retailers?

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Asked: 5 months ago
Asked by Lo H. Khamis

I'm trying to understand who is eligible to serve as the Responsible Person for my cosmetic products in the EU. Does it depend on where my products are manufactured, and what are the different scenari...

๐Ÿ’ฌ 1 โœ“ ๐Ÿ‘๏ธ 28 ๐Ÿ‘ 0
Asked: 5 months ago
Asked by Lo H. Khamis

I'm new to EU cosmetics regulations and keep hearing about the "Responsible Person" requirement. Can you explain what an EU Cosmetics Responsible Person is in simple terms and why it's required?

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Asked: 5 months ago
Asked by Lo H. Khamis

For sponsors developing a novel medical device, such as an AI-powered diagnostic tool with no clear predicate, the FDA's Q-Submission (Q-Sub) program is a critical mechanism for obtaining early agency...

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Asked: 5 months ago
Asked by Lo H. Khamis

For a startup launching a Class I medical device, such as an elastic bandage or tongue depressor, navigating the "General Controls" can be complex due to common misconceptions about exemptions. While ...

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Asked: 5 months ago
Asked by Lo H. Khamis

When preparing a 510(k) for a medical device, such as a Class II Software as a Medical Device (SaMD) for diagnostic imaging analysis, a sponsor may identify a suitable predicate device that has very l...

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Asked: 5 months ago
Asked by Lo H. Khamis

When developing a performance testing strategy to demonstrate substantial equivalence for a 510(k), how should a sponsor systematically translate the differences between their new device and a chosen ...

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Asked: 5 months ago
Asked by Lo H. Khamis

When preparing a 510(k) for an innovative Software as a Medical Device (SaMD) that utilizes an advanced technology like an AI/ML algorithm, a significant challenge arises if the most suitable predicat...

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Asked: 5 months ago
Asked by Lo H. Khamis

For medical device companies preparing for the upcoming fiscal year, how should they navigate the annual FDA establishment registration process to ensure uninterrupted U.S. market access? This mandato...

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Asked: 5 months ago
Asked by Lo H. Khamis
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