General Questions 

What is a Packaging Assembly? 

A Packaging Assembly is a reusable record that represents the packaging materials and components associated with a finished product. Packaging Assemblies can be linked to one or more products and UPCs and may be used to satisfy customer or regulatory packaging compliance requirements. 

 

Why is WERCSmart adding Packaging Assembly management? 

Many customers and regulatory programs require suppliers to provide information about packaging composition and packaging-related compliance obligations. The new Packaging Assembly capability allows suppliers to manage packaging information in a centralized location and reuse that information across multiple product registrations. 

 

Will I need to create a Packaging Assembly for every product? 

Not necessarily. If multiple products use the same packaging configuration, a single Packaging Assembly may be reused across those products, reducing duplicate data entry. 

 

Packaging Assembly Questions 

What information may be required when creating a Packaging Assembly? 

Depending on customer and compliance requirements, you may be asked to provide: 

  • Packaging Name 
  • Packaging Type 
  • Internal SKU or Identifier (optional) 
  • Packaging Notes (optional) 

  • Packaging chemical group information, including when applicable Declarations of Compliance 

 

Can Packaging Assemblies be associated with multiple products? 

Yes. Packaging Assemblies are designed to be reusable and can be associated with multiple products and UPCs when the same Chemical Group / Declarations are applicable. 

  

Can I update a Packaging Assembly after it has been created? 

Yes. Packaging Assemblies can be maintained and updated as packaging specifications change. Updates may affect future compliance evaluations for products using that Packaging Assembly. 

 

Are Packaging Assemblies required for all registrations? 

No. Packaging requirements depend on customer configuration, regulatory requirements, recipient participation, and product-specific reporting obligations. Some registrations may not require Packaging Assembly information but can be provided at your discretion. 

 

Chemical Group Reporting Questions 

Why am I being asked for Chemical Group information? 

Some customers and regulatory programs require suppliers to disclose information about specific regulated chemical groups that may be present in products or packaging materials. The Portal uses this information to support compliance reporting and customer requirements.  

 

What is changing in the Chemical Group workflow? 

The reporting process has been streamlined to provide a more consistent experience across Articles and Packaging Assemblies. Suppliers may also be able to provide fewer supporting documents through the use of broader declaration options. 

 

Can I submit a single Declaration of Compliance instead of multiple declarations? 

In many cases, yes. The enhanced workflow supports a single Declaration of Compliance that may cover multiple Chemical Groups when appropriate. This can reduce the number of documents that need to be uploaded and maintained. 

 

What happens if a Chemical Group is present? 

If a regulated Chemical Group is identified as present, additional information may be requested regarding the applicable chemical(s) and supporting compliance documentation. 

 

Medical Device Questions 

What types of Medical Device products are affected? 

Registrations that are within the following categories may encounter Medical Device data collection when the registration is associated to a retailer requiring Chemical Group data for the product: 

  • Formulated Registrations: 
    • Health & Beauty 
    • Over the Counter 
    • Pharmacy 
  • Article Registrations: 
    • General Articles (no formulation) 
    • Battery-Containing Products 
    • Electronics 

 

While many medical devices contain batteries or electronic components, some formulated products may also be considered medical devices based on their intended use, claims, or method of action.  The examples below are intended to help identify products that may be considered medical devices by the FDA.  They are not all-inclusive, and other products may also qualify as medical devices based on their intended use and FDA classification. 

 

Examples of formulated products that may be regulated as medical devices include: 

  • Wound dressings and wound care gels 
  • Hydrogel and burn treatment products 
  • Scar management gels and dressings 
  • Medical lubricants 
  • Barrier creams and skin protectants intended to prevent or manage medical conditions 
  • Moisture barrier products used for incontinence care 
  • Contact lens care and conditioning solutions 
  • Certain ophthalmic products intended primarily for physical rather than chemical action 
  • Certain oral care products intended for relief of dry mouth through physical action 
  • Nasal irrigation and saline products that function through mechanical action 
  • Surgical and procedural lubricants 

 

Additional product examples that may be electronic or battery-containing products are: 

  • Blood glucose monitors 
  • Continuous glucose monitors (CGMs) 
  • Digital blood pressure monitors 
  • Digital thermometers 
  • Hearing aids 
  • Electronic Nebulizers 
  • Smart health monitoring devices 

Why are registrations encountering additional Medical Device questions? 

Certain customer and regulatory requirements require additional information to better understand the materials and substances present within a product or component. These enhancements help ensure complete and accurate compliance reporting. 

 

What additional information may be requested? 

Depending on the registration, you may be asked to provide U.S. Food and Drug Administration (FDA) information for a marketed medical device. 

 

This information may include: 

  • A 510(k) number; or 
  • A Unique Device Identifier (UDI); or 
  • Confirmation that the product is not considered a medical device by the FDA. 

 

If a 510(k) number or UDI is provided, WERCSmart will attempt to validate the information against FDA records. If a matching record is not found, you may also be asked to select the product FDA Device Class from a list of FDA-defined classes. 

 

Existing Registration Questions 

Will my existing registrations be automatically updated? 

No. Existing registrations will remain in the system. However, when registrations are updated, renewed, recertified, or resubmitted, additional Packaging Assembly or Chemical Group information may be requested if applicable. 

 

Will these changes affect submissions already under review? 

Current reviews will generally continue to follow established processes. Future updates or resubmissions may require additional information depending on applicable customer requirements and compliance rules. 

 

Support Questions 

How can I determine whether Packaging Assembly reporting applies to my product? 

Packaging requirements are determined by the product, associated retailer requirements, regional applicability, and compliance program configuration. The Portal will indicate when packaging information is required during registration. 

 

What documentation should I gather before beginning? 

You may find it helpful to have access to: 

  • Supplier declarations 
  • Packaging specifications 
  • Test reports 
  • Compliance certifications 
  • Material composition information 

 

Who should I contact if I need assistance? 

If you have questions regarding Packaging Assemblies, Chemical Group reporting, or Medical Device compliance requirements, please contact the WERCSmart Support Team through the Support Solution Center. 

 

Quick Start Checklist for Suppliers 

Before your next registration, we recommend: 

  • Identify reusable packaging configurations 
    • Establish Packaging Assemblies 
  • Gather Declarations of Compliance when Chemical Groups are not present. 
  • Verify Medical Device material information 
  • Familiarize your team with the new Packaging workspace