Regulatory policy

1. Introduction

1.1. At Newfoundland Diagnostics Ltd [Newfoundland], we are committed to
complying with all applicable regulatory requirements in the markets in which
we operate. This policy outlines our approach to ensuring regulatory
compliance across all jurisdictions, including the UK, and highlights the
importance of high-quality standards, risk management, and continuous
improvement.

1.2. As part of our commitment to ethical business practices, this policy ensures that our products and services comply with UK regulations, including those related to healthcare, environmental protection, data security, and public
procurement standards.

2. Purpose

2.1. The purpose of this policy is to:
2.1.1. Ensure compliance with all relevant laws, regulations, and
standards across all markets where Newfoundland operates.
2.1.2. Minimize regulatory risk and maintain the quality of products and
services.
2.1.3. Foster strong relationships with regulatory bodies to ensure
ongoing compliance and collaboration.
2.1.4. Support compliance with key UK legislation, including the UK
Medical Devices Regulations, Bribery Act 2010, Modern Slavery
Act 2015, UK GDPR, and Health and Safety Regulations.
2.1.5. Ensure that regulatory compliance is integrated into product
development, supplier management, and risk management
processes.

3. Scope

3.1. This policy applies to all Newfoundland employees, contractors, and
suppliers across all regions, with a particular focus on compliance with:

3.1.1. UK Medical Devices Regulations (for applicable products)
3.1.2. Data Protection Act 2018 and UK GDPR
3.1.3. Bribery Act 2010
3.1.4. Environmental Protection Regulations
3.1.5. Health and Safety Regulations

3.2. It covers the entire product lifecycle, from product development to market
entry and ongoing product management. This includes working with
suppliers, subcontractors, and other third parties involved in the supply chain.

4. Regulatory Compliance Principles

4.1. Our approach to regulatory compliance is based on the following principles:
4.1.1. Proactive Compliance:
4.1.2. Regulatory compliance is an ongoing process, starting from product development. We take a proactive approach by integrating regulatory assessments early in the product lifecycle to identify and mitigate risks.
4.1.3. Regularly engage with regulatory bodies, including the Medicines and Healthcare products Regulatory Agency (MHRA) and other relevant authorities, to stay updated on changes to regulations and ensure our products and services meet current standards.

4.2. Reactive Measures:
4.2.1. We maintain processes to address any regulatory issues that
arise. If non-compliance is identified, immediate steps are taken to
rectify the situation and prevent recurrence.
4.2.2. A Regulatory Forum is held regularly to discuss and address
global risks and escalate concerns to corporate leadership when
necessary.

4.3. Supplier and Product Onboarding:
4.3.1. All new suppliers must comply with our Supplier Management Procedure to ensure that they meet the relevant regulatory standards.
4.3.2. New products undergo a comprehensive regulatory review, ensuring that they comply with UK Medical Devices Regulations, environmental laws, and other applicable standards.

4.4. Risk-Based Approach:
4.4.1. Decisions regarding regulatory compliance are made using a risk-based approach, prioritizing areas with higher regulatory exposure.
4.4.2. This approach helps us assess the potential risks in each jurisdiction and take necessary actions to mitigate them.

4.5. Engagement and Collaboration:
4.5.1. We actively engage with regulatory bodies, fostering relationships that help ensure smooth product approvals and ongoing compliance.
4.5.2. Our internal teams work in collaboration with local market representatives to ensure that all in-market products meet jurisdictional regulatory requirements.

5. Roles and Responsibilities

5.1. Leadership:
5.1.1. The leadership team is responsible for promoting a culture of compliance and ensuring that all employees understand and adhere to regulatory requirements.
5.1.2. Regulatory risks and issues are escalated to senior
management, including the Head of Quality & Regulatory and the
CEO, to ensure proper oversight.

5.2. Employees:
5.2.1. All employees are expected to comply with relevant standards and regulations in their respective roles. Training on regulatory requirements is provided as part of employee onboarding and ongoing professional development.

5.3. Regulatory Team:
5.3.1. The Regulatory Team is responsible for ensuring that regulatory
compliance is integrated into product development, supplier
management, and risk management processes.
5.3.2. The team also manages relationships with regulatory bodies and
coordinates audits and inspections.

6. Monitoring and Continuous Improvement

6.1. To ensure ongoing compliance, Newfoundland conducts regular reviews of
regulatory policies and procedures. Monitoring and auditing are carried out
through:
6.1.1. Internal Audits: Regular audits of internal processes and supplier operations to ensure compliance with applicable regulations.
6.1.2. External Audits: Engagement with third-party auditors or regulatory bodies to validate compliance.
6.1.3. Regulatory Forum: Bi-weekly meetings to discuss global regulatory activities and risks, enabling early identification and mitigation of potential compliance issues.

6.2. Continuous improvement is a core component of our regulatory approach.
We are committed to incorporating feedback from regulatory bodies, audits,
and internal reviews to strengthen our regulatory processes.

7. Data Protection and GDPR Compliance

7.1. We ensure compliance with the UK GDPR and the Data Protection Act 2018
by:
7.1.1. Protecting the personal data of customers, employees, and suppliers.
7.1.2. Ensuring that data collected during regulatory processes is processed in accordance with applicable laws and regulations.
7.1.3. Regular training is provided to employees on data protection
and privacy obligations.

8. Product Recalls and Issue Resolution

8.1. In the event of a product recall, we follow our Recall Procedure, which
ensures a coordinated, timely response to protect public health and safety.
This includes:
8.2. Notifying relevant authorities, including the MHRA, and stakeholders.
8.3. Coordinating with distributors, suppliers, and other third parties to remove
affected products from the market.

9. Policy Review and Amendments

9.1. This policy will be reviewed annually, or as required, to ensure it remains
compliant with current regulations and reflects best practices. Updates to the
policy will be approved by the Head of Quality & Regulatory and the CEO.
9.2. Any queries should be directed to: regulatory@newfoundland.io

—

Frequency of Review: 2 Years
Approved by Freddie Jackson – Head of Operations
Date: 04.10.2024