ISO 13485:2003 Requirements by Country/Region

ISO 13485:2003 is an international quality system standard developed and published by the International Organization for Standardization, based in Switzerland. The organization, most commonly known as ISO, is non-governmental network of national standards institutes. Some of its members are part of their respective governments while others are organizations started by industry associations or private sector partnerships. ISO coordinates the efforts of its members, building consensus on solutions that benefit society. ISO 13485:2003 is the result of their collaboration in the medical device industry. ISO 13485 is based on ISO 9001 but is focused on meeting national regulations rather than promoting continuous improvement and customer satisfaction.

The chart below shows the medical devices for which ISO 13485 certification is required and a partial list of countries in which ISO 13485:2003 is recognized. Many secondary markets do not have their own unique quality system regulations but accept ISO 13485 certificates as proof of compliance with their national “regulations” governing medical device quality. The ISO 13485 standard is increasingly recognized as the “de facto” quality management system for medical device companies worldwide, although it is not accepted by the US FDA as a way to meet the US Quality System Regulation.

AUSTRALIA

ISO 13485:2003 is not required in Australia but is considered the easiest way to demonstrate compliance with the Australian Therapeutic Goods Act. It applies to companies that manufacture any medical device that falls within these classifications:

• Class I (Sterile or Measuring function)
• Class IIa
• Class IIb
• Class III

CANADA

ISO 13485:2003 is REQUIRED in Canada. Companies must also meet the Canadian Medical Device Regulations (CMDR) which impose some additional requirements beyond ISO 13485:2003. It is important to note that not all Notified Bodies (called Registrars in Canada) are authorized to conduct audits for compliance with CMDR. Only those that comply with the Canadian Medical Devices Conformity Assessment System (CMDCAS) are permitted to issue ISO 13485:2003 certificates that include CMDR within the scope of registration. If you intend to sell in Canada, make sure your auditor isCMDCAS certified. ISO 13485:2003 certification is required for devices in these classes:

• Class II
• Class III
• Class IV

CHINA

ISO 13485:2003 is not required in China but is accepted as proof of meeting Chinese quality system requirements which are modeled after ISO 13485:2003. Proof of US FDA GMP compliance is also accepted. QMS requirements apply to these medical device classifications:

• Class II
• Class III

EUROPE*

ISO 13485:2003 is NOT REQUIRED for CE Marking in Europe. This is commonly misunderstood. However, ISO 13485:2003 certification is considered the easiest way to demonstrate compliance with the Health and Safety requirements of the Medical Devices Directive (93/42/EEC) and the In-Vitro Diagnostic Devices Directive (98/79/EC). For this reason, most medical device companies choose this route to compliance. It applies to:

• Class I (Sterile or Measuring function)
• Class IIa
• Class IIb
• Class III
• IVD – List A, List B, Self-test**

JAPAN

Japanese Ministry of Health, Labour and Welfare (MHLW) Ordinance #169 is based on ISO 13485:2003 and is required in Japan. Companies must also meet the requirements set forth in the Pharmaceutical Affairs Law (PAL). Applies to these medical devices:

• Class II – Designated Controlled
• Class II – Controlled
• Class III – Specially Controlled
• Class IV – Specially Controlled

For more information about the ISO 13485:2003 requirements or consulting support, please contact us.