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ISO 13485 & MDR Blog

List of worldwide regulations that require implementation of ISO 13485

Regulatory requirements for medical devices are becoming tighter every year. Manufacturers are expected to prove that their quality management processes are under control to ensure best practice in everything they do, while observing an increasing number of regulations in many countries.

What countries require ISO 13485 certification?
  • Europe – the MDR and ISO 13485:2016.
  • Canada – CAN/CSA-ISO 13485:2016.
  • USA – US Quality System Regulations (21 CFR 820) together with ISO 13485.
  • Japan – ISO 13485.
  • Australia – The Therapeutic Goods document requires ISO 13485:2016.
  • Singapore – ISO 13485.
  • Malaysia – The Medical device act (Act 737) requires ISO 13485.

Because ISO 13485 has gained significant recognition around the world, in this article we will discuss how the requirements of the standard are applicable to manufacturers of medical devices in different countries.

What is the worldwide situation considering the obligations of ISO 13485?

Europe. Companies active in the EU market are expected to have a Quality Management System (QMS) certified under ISO 13485:2016, according to the MDR 2017/745. This applies to the following business entities:

  • Medical device manufacturers – meaning both manufacturers of medical devices and in vitro diagnostic devices, as well as manufacturers of the devices listed in Annex XVI of the MDR
  • Medical device developers, including software as a medical device
  • Medical device contract manufacturers
  • Manufacturers of medical device parts or components as described in MDR Article 23 and In Vitro Diagnostic Medical Device Regulation (IVDR) Article 20
  • Service providers for medical device installation, servicing, or maintenance
  • EU distributors or importers that undertake activities corresponding to manufacturer obligations described in MDR/IVDR Article 16(1)

List of countries that require ISO 13485 certification

Canada. Canadian Medical Device Regulations (SOR 98-282) require QMS certification under the Canadian version CAN/CSA-ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes.

USA. The US Food & Drug Administration (FDA) has Title 21 Code of Federal Regulation (CFR) Part 820 Quality System Regulation. This regulation is the current quality system for medical devices used by the FDA. While there are many similarities, ISO 13485:2016 is more up to date than 21 CFR 820. But because ISO 13485 is so widespread, the FDA issued in December 2018 a proposed rule to harmonize the US Quality System Regulations (21 CFR 820) with ISO 13485 and make ISO 13485 mandatory. However, the proposed change is not yet mandated by law.

Saudi Arabia. In April 2019, the Saudi Food & Drug Authority (SFDA) published the document MDS-35 Guidance to Implement a Medical Devices Standard “Quality Management System” Regulatory Requirement (ISO 13485:2016).
In January 2020, the SFDA published the document MDS 45 – Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives.

Japan. Japan has largely embraced ISO 13485 as the basis for their QMS requirements. However, Japanese Ministerial Ordinance on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic devices (MHLW MO 169) contains additional QMS requirements that medical device manufacturers must meet to be in full compliance.

Malaysia. The Medical device act (Act 737) requires all manufacturers to have implemented a Quality Management System according to the ISO 13485 standard. Other entities, like distributors, importers, and authorized representatives, must be in compliance with the good distribution practice of medical devices (GDPMD).

Singapore. Singapore requires that medical device manufacturers have an ISO 13485-compliant QMS as described in the document Health Products (Medical Device) Regulations 2010.

Australia. The document Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, published on March 26, 2019, states that the conformity assessment standard for Quality Management Systems is ISO 13485:2016.

Globally recognized certification

From this review, it can be seen that ISO 13485 is recognized worldwide as a major standard in quality assurance systems for medical device manufacturers. Although some markets have some updates, ISO 13485 still remains the main base.

To learn more about the ISO 13485 requirements and how to implement them, download this free white paper: Clause-by-clause explanation of ISO 13485:2016.

Advisera Kristina Zvonar Brkic
Kristina Zvonar Brkic

Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and auditor and assessor for MDD.

The portfolio of medical devices for which she has approval is plastic products with measuring function, various creams and gels, different systems for wound care, disinfectants, dental materials, different catheters, panels for operating rooms and clean rooms, accessories, and kits for performing surgical procedures of non-woven materials, medical gases, and various dental materials.