Medical Device Market Access: Understanding MDSAP, UKCA and International Requirements

Medical device manufacturers operating internationally must navigate different regulatory requirements across multiple markets. Certification, quality management, technical documentation and conformity assessment requirements can vary between jurisdictions, making coordinated regulatory planning essential.

Taking an integrated approach can help manufacturers anticipate requirements, reduce unnecessary duplication and prepare the documentation and evidence needed to support access to target markets.

Planning for international medical device market access

When the same medical device is intended for multiple markets, manufacturers should consider the regulatory requirements of each jurisdiction early in the planning process.

This includes reviewing:

• Target markets
• Applicable regulatory frameworks
• Device classification and intended purpose
• Quality management system requirements
• Existing certifications
• Technical and clinical documentation
• Market-specific evidence requirements
• Applicable transition arrangements
• Available conformity assessment routes

Understanding these requirements together can help manufacturers identify where evidence, audits or quality processes can support more than one market and where additional market-specific activities will be required.

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) enables a medical device manufacturer's QMS to be audited against the requirements of participating regulatory authorities through a single audit program.

It is particularly relevant to manufacturers targeting Australia, Brazil, Canada, Japan and the United States.

For organizations operating internationally, MDSAP can support a more coordinated approach to quality management system auditing and reduce some of the duplication associated with separate regulatory audits.

How does MDSAP support international planning?

Manufacturers entering several regulated markets need to understand both the common requirements and the differences between jurisdictions.

MDSAP can provide a common auditing framework across participating markets, but manufacturers must still consider the regulatory requirements that apply to their products in each jurisdiction.

Organizations should therefore consider MDSAP as part of a broader market access strategy that aligns the QMS, regulatory planning and product documentation.

Placing medical devices in the Great Britain market

Manufacturers seeking access to the Great Britain market (England, Scotland and Wales) must also consider the applicable UK medical device regulatory and conformity assessment requirements.

UKCA forms part of this regulatory landscape alongside applicable transitional arrangements and other recognized routes. Manufacturers should establish which requirements apply to their particular device and planned market-entry timeline before beginning the assessment process.

This is particularly important when the same product is being marketed in Great Britain as well as the European Union or other international markets, because the regulatory route, documentation and conformity assessment arrangements may differ.

Coordinating requirements across markets

A global market access strategy should look beyond individual certifications. When planning entry into several jurisdictions, manufacturers should review the relationship between:

• Quality management system requirements
• Product certification and conformity assessment
• Technical documentation
• Clinical or performance evidence
• Risk management
• Existing approvals and certifications
• Market-specific regulatory requirements

An integrated approach can help organizations identify opportunities to use common processes and evidence while ensuring that differences between markets are addressed appropriately.

Build market access into your regulatory strategy

International medical device market access is easier to manage when regulatory planning begins early in the product life cycle.

Rather than considering each certification or jurisdiction in isolation, manufacturers can benefit from establishing a coordinated strategy covering target markets, the QMS, technical documentation, evidence and conformity assessment.

This can help reduce duplication, improve regulatory readiness and provide greater visibility of the requirements and activities needed to support market entry.

How SGS can help

We provide medical device regulatory compliance, testing, assessment and certification services across international markets. Our specialists support manufacturers with areas including ISO 13485, EU Medical Device Regulation (MDR), the EU In Vitro Diagnostic Medical Device Regulation (IVDR), the UK Medical Device Regulations (UK MDR) 2002 and the Medical Device Single Audit Program (MDSAP).

With expertise across multiple regulatory frameworks, we can help you understand applicable requirements and develop a coordinated approach to certification and international market access.

Explore our medical device services and discover how SGS can support your international market access strategy on our webpage.