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YY/T 0606.3-2007Tissue engineered medical products - Part 3: General classification (English PDF)

组织工程医疗产品第3部分：通用分类

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 31, 2007

Implementation date

January 1, 2008

Scope

YY/T 0606.3-2007 is the English-translated version of 组织工程医疗产品第3部分：通用分类.

YY/T 0606.3 is Part 3 of the Chinese tissue engineered medical product series and sets out the general classification for the field.

Tissue engineered products sit awkwardly between devices, biologics and cell therapies, and a classification is what determines which requirements apply to a given product: a scaffold alone, a scaffold seeded with cells, and a cell preparation with no scaffold raise different questions and different evidence.

As the earliest part of a series that now runs to more than a dozen documents, it established the framework that YY/T 1995, YY/T 1985 and the other tissue engineering standards fit into.

For a manufacturer developing a tissue engineered product for China, this is where the regulatory classification of the product starts.

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Document preview — YY/T 0606.3-2007

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C45

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 31 January 2007 by the National Medical Products Administration and takes effect on 1 January 2008.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

It is classified under ICS 11.040.40, Chinese classification C45.

1 Scope

YY/T 0606.3 is Part 3 of the Chinese tissue engineered medical product series and sets out the general classification for the field. Tissue engineered products sit awkwardly between devices, biologics and cell therapies, and a classification is what determines which requirements apply to a given product: a scaffold alone, a scaffold seeded with cells, and a cell preparation with no scaffold raise different questions and different evidence. As the earliest part of a series that now runs to more than a dozen documents, it established the framework that YY/T 1995, YY/T 1985 and the other tissue engineering standards fit into. For a manufacturer developing a tissue engineered product for China, this is where the regulatory classification of the product starts.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Cited by

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