Food, cosmetics and medical devices

Frequently required services

• Foodstuffs

  Foodstuffs

  Strategic consultation

  • Analysis of your product and the possible product categories
  • Selection of the right product category considering various criteria: Opportunities and risks, planned advertising and sales channels, product life cycle and quality management requirements, costs and regulatory time expenditure
  • Classification into food groups
  • Assessment in relation to novel food, botanicals (expert reports)
  • Choice of sales channels and their requirements
  • Training in the field of food law

   

  Operational support

  • Project management for approval and notification procedures from the Swiss Federal Office for Food Safety and Veterinary Matters (BLV) for novel products, health claims, FSMP 
  • Registration of the company with the cantonal authorities
  • Determination of the legally compliant product requirements

  • Creating and checking legally compliant labelling

  • Evaluation of clinical trials for a health claim application

  • Review of advertising materials for their legal compliance
  • Development and implementation of a self-control concept
• Cosmetics

  Cosmetics

  Strategic consultation

  • Analysis of your product and the possible product categories

  • Selection of the right product category considering various criteria: Opportunities and risks, planned advertising and sales channels, product life cycle and quality management requirements, costs and regulatory time expenditure
  • Definition of the cosmetic group and differentiation from other items of daily use or consumer goods

   

  Operational support

  • Advice on the creation of the product information file (PID)

  • Creation of the safety report

  • Determination of the legally compliant product requirements
  • Verification of the legal compatibility of formulations

  • Creating and checking legally compliant labelling

  • Reviewing the legal compliance of advertising materials
• Medical devices – market access procedures

  Medical devices – market access procedures

  In the field of market access procedures, we would be happy to advise you on the following questions:

  Strategic consultation

  • Analysis of your product and the possible product categories

  • Selection of the right product category considering various criteria: Opportunities and risks, planned advertising and sales channels, product life cycle and quality management requirements, costs and regulatory time expenditure

  • Indicating the consequences of classification

   

  Operational support

  • Preparation of technical documentation with clinical evaluation (in cooperation with an external partner)
  • Determination of the legally compliant product requirements
  • Classification of medical devices

  • Differentiation from borderline product categories

  • Control of legally compliant labelling and adaptation to CH regulations
  • Reviewing the legal compliance of advertising materials
• Medical devices – health insurance reimbursement

  Medical devices – health insurance reimbursement

  In Switzerland, the Material and Item List (MiGeL) uses categories to define how medical devices are to be reimbursed by the health insurance companies.

  If a new medical device cannot be assigned to an existing category, it is possible to apply to the Swiss Federal Office of Public Health (BAG) for a new main category or subcategory. To achieve this, clinical data must prove the efficacy and safety of the medical device and the appropriateness of the treatment. From the point of view of the Swiss healthcare system, economic viability and financial consequences must be demonstrated.

  We provide our expertise in the following areas:

  Strategic consultation

  • Defining the right pricing strategy (comparator product or standard method)
  • Negotiations with the authorities (Swiss Federal Office of Public Health (BAG)

  • Assessment of notifications and decisions of the authorities

  • Development of counter arguments
  • Support in case of technical enquiries during the application process

   

  Operational support

  • Drafting of health insurance reimbursement applications
  • Literature searches and evaluation for decision-supporting arguments