In a world where precision is paramount, ensuring that measuring instruments meet global regulatory standards is crucial for manufacturers. The Product Compliance Institute offers a comprehensive suite of features designed to guide manufacturers through the labyrinth of international regulations. This service is tailored to assist companies in achieving compliance across various markets, promoting innovation, reliability, and market access.

Key Features:

1. Regulatory Landscape Navigation:
   • Continuous monitoring of international regulations, such as the European Union’s Measuring Instruments Directive (MID), ensuring compliance with metrological requirements.
   • Adherence to the International Organization of Legal Metrology (OIML) standards, which are widely accepted globally, ensuring harmonization.
2. Customized Compliance Strategies:
   • Tailored strategies for different types of measuring instruments, considering the specifics of regulations such as the US National Institute of Standards and Technology (NIST) requirements for calibration services.
   • Guidance on compliance with the International Electrotechnical Commission (IEC) standards for electrical measuring instruments.
3. Global Regulatory Submissions:
   • Expertise in submissions for the Federal Communications Commission (FCC) compliance in the United States for electronic measuring instruments.
   • Assistance in obtaining the Conformité Européenne (CE) mark for products distributed in the European Union, ensuring compliance with relevant directives.
4. Quality Management Systems (QMS):
   • Development and implementation of QMS compliant with ISO 9001 for quality management.
   • Adherence to ISO/IEC 17025 for calibration laboratories, ensuring the reliability and traceability of measurement results.
5. Post-Market Surveillance and Reporting:
   • Vigilant monitoring of post-market performance and compliance with regulations such as the UK Weights and Measures Act.
   • Timely reporting to regulatory authorities, aligning with the reporting requirements of the US Food and Drug Administration (FDA) for certain measuring instruments.
6. Labeling and Packaging Compliance:
   • Ensuring compliance with the OIML R 126 standard for labeling and packaging of measuring instruments.
   • Expertise in meeting the packaging requirements outlined in the European Directive 2014/31/EU for non-automatic weighing instruments.
7. Audit and Inspection Readiness:
   • Preparation for audits based on standards like ISO/IEC 17020 for inspection bodies.
   • Conducting mock audits aligned with specific regional requirements, such as those outlined in the Japanese Measurement Law.
8. Global Market Access Support:
   • Assistance in navigating the diverse regulatory landscapes of major markets, including China’s State Administration for Market Regulation (SAMR) requirements.
   • Coordination with in-country representatives for compliance with specific regional regulations, such as Australia’s National Measurement Institute (NMI) requirements.

Examples of various regulations affecting medical devices worldwide:

• Chinese Taipei: Regulations Governing Verification and Inspection of Measuring Instruments
• UAE: UAE Technical regulations  for legal measuring instruments
• Korea: Environmental Testing and Inspection Act
• Argentina: Periodic Verification, Initial Verification and Usage Monitoring – List of Measuring Instruments
• Montenegro: Rulebook on metrological requirements for measuring instruments for testing safety measures in electrical engineering
• Mercosur: Reglamento Técnico MERCOSUR “Criterios Generales de Metrología Legal” (MERCOSUR Technical Regulation “General Criteria for Legal Metrology”)

Do not hesitate to contact us directly to talk about your challenges regarding the global regulatory compliance for measuring instruments.