This guideline document to assist the high quality development of the recombinant collagen based medical device industry

A few days ago, CFDA issued the Classification and Definition Principles for Recombinant Collagen Medical Products(hereinafter referred to as the Classification and Definition Principles) to further clarify the management attributes and management categories of recombinant collagen medical products, and provided the guidance documents for the classification and definition and the compliance of innovative product research and development.

Multi-party cooperation to quickly complete the preparation

Recombinant collagen has been used as a raw material in medicine, cosmetics and other fields due to its good biological properties, biodegradability and low immunogenicity.During the research and development of such products, their management attributes should be determined according to the expected use and utility realization of the design, that is, according to the management of drugs, medical devices, cosmetics, or other types of products, otherwise there may be risk of compliance with market access.
For example, do skin care products containing recombinant collagen belong to medical devices or cosmetics?If the product is regulated by medical device, the management category should be determined according to the degree of risk.Collagen products included in the Classification Catalog of Medical Devices (2017 edition) are mainly compiled and formulated for medical devices with collagen extracted from animals. Currently, there is no guidance document on the classification and definition of medical devices with recombinant collagen.
In order to fill this missing item as soon as possible and standardize the classification and definition of medical products containing recombinant collagen, the Medical Device Standards Management Center of the State Food and Drug Administration led and organized several technical units to form a drafting group and completed the compilation of the Classification and Definition Principles.

Scientific formulation of classification principles

The Principles of Classification and Definition are formulated based on the risk management principles of the Regulations on the Supervision and Administration of Medical Devices .
In the application scope of the Classification and Definition Principles , the term meaning of recombinant collagen medical products is given, that is, the recombinant collagen medical products stipulated in the Principles refer to the products with recombinant collagen as the main component and for the purpose of medical treatment.This clause indicates the principal ingredients and intended purpose of the product, to distinguish it from non-recombinant collagen as the principal ingredient and products for non-medical purposes.

The  Classification and Definition Principles clarifies the principles for determining the management attributes of recombinant collagen medical products, specifying the specific circumstances of products that are not managed as medical devices, managed as a combination of drugs and devices, and managed as medical devices, and guide the determination of the management attributes of such products .

Recombinant collagen is a new kind of biomaterial, which is processed by recombinant technology in genetic engineering, and has some potential risks.According to the principle of risk management, the current regulatory measures for the class I medical devices are insufficient to guarantee the safety and effectiveness of recombinant collagen medical devices.Therefore,  Classification and Definition Principles clarifies the general principles of management categories, and stipulates that the management of recombinant collagen-based medical devices should not be lower than the second category.

On the basis of studies on the management category of collagen based medical devices as well as the situation with existing marketed recombinant collagen based medical devices, with respect to products in the form of passive implants, surgical hemostatic and antiadhesive materials, medical dressings, and other forms most likely to be applied by recombinant collagen based biomaterials in the medical device field, the Principles of Classification and Definition defines principles that specify specific principles for management category adjudication,and established principles of taxonomy coding, making the Classification and Definition Principles more instructive.

There are also specific requirements for the implementation of the Classification and Definition Principles  .The registration certificate of the recombinant collagen product which has been approved to be registered as a medical device shall continue to be valid within the period of validity.If the registration certificate expires during the period of product category conversion, the registrant may apply to the original examination and approval department for the extension of the original registration certificate.If the extension is granted, the term of validity of the original registration certificate shall in principle not exceed December 31, 2023.

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