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YY/T 0954-2026Nonactive surgical implants - Type I collagen implants (English PDF)

无源外科植入物 I型胶原蛋白植入剂

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 9, 2026

Implementation date

March 1, 2027

Scope

YY/T 0954-2026 is the English-translated version of 无源外科植入物 I型胶原蛋白植入剂.

YY/T 0954 is the product standard for injectable and implantable type I collagen, the material used in soft tissue augmentation, dermal filling and tissue repair.

As a standard for a non-active surgical implant it addresses the material and the finished implant together, since with collagen the two cannot be separated: the source tissue, the extraction route and the crosslinking determine what the implant does in the body.

It is the finished-product counterpart to YY/T 1985 on collagen as a tissue engineering raw material, revised in the same period.

For a manufacturer of collagen fillers or collagen-based implants seeking registration in China, this is the standard the product specification is written against, and for a foreign supplier it is the document a Chinese partner will cite when qualifying the material.

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Document preview — YY/T 0954-2026

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 9 March 2026 by the National Medical Products Administration and takes effect on 1 March 2027.

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.

1 Scope

YY/T 0954 is the product standard for injectable and implantable type I collagen, the material used in soft tissue augmentation, dermal filling and tissue repair. As a standard for a non-active surgical implant it addresses the material and the finished implant together, since with collagen the two cannot be separated: the source tissue, the extraction route and the crosslinking determine what the implant does in the body. It is the finished-product counterpart to YY/T 1985 on collagen as a tissue engineering raw material, revised in the same period. For a manufacturer of collagen fillers or collagen-based implants seeking registration in China, this is the standard the product specification is written against, and for a foreign supplier it is the document a Chinese partner will cite when qualifying the material.

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 — 20 pages — is available in the English PDF.

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