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Food and Drugs Administration (FDA)
Quality management requirements are based on 21 CFR Part 820.
Agência Nacional de Vigilância Sanitária (ANVISA)
Quality management requirements are based on RDC ANVISA 16/2013.
JapanMinistry of Health Labor and Welfare & Pharmaceuticals and Medical Devices Agency (MHLW & PMDA)
Quality management requirements are based on MHLW Ordinance No. 169.
Health Canada
Quality management requirements are based on ISO 13485:2016.
Therapeutic Goods Administration (TGA)
Quality management requirements are based on TGA regulation (TG(MD)R Sch3).
Direct nonconformities (Chapter 6.4 to 8.5) are the high-risk issues and starting at grading level 3 (first nonconformity) or grading level 4 (repeated nonconformity). Depends on the deviation, additional gradings can be put on top. For example, the deviation has an absence of procedure or it ends in a non-conformity product on the market (+1 Level each).
Indirect nonconformities (Chapter 4.1 to 6.3) are the low-risk issues and normally starting with grading level 1 (first nonconformity) or grading level 2 (repeated nonconformity). Depends on the deviation, additional gradings can be put on top. For example, the deviation has an absence of procedure or it ends in a non-conformity product on the market (+1 Level each).
If the Auditing Organization finds three or more 4 levels or one or more 5 levels, these are strong indicators that you will not pass the audit.
This timeline shows the next steps of both manufacturer and Auditing Organization after an audit ends.
To develop medical products that improve quality of life and extend life expectancy is the goal of the medical device industry. In order to serve this basic need optimally, laws and regulations are inevitable. Such regulations ensure safety and quality of products as well as raise the state of the art and thus promote progress steadily. This is the reason why it is so important to take the new requirements as an opportunity for improvements and not as a burden. Only companies that recognize this will be successful in the long term.
This is where the task of Regulatory Globe begins. Together with our partners, we specialize in monitoring laws and regulations and provide tools that help our clients improve their products processes. This will eventually benefit the people in need of these medical devices. Visit our website to learn more by clicking here.
