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CDMO platform

CDMO platform

Biochemical immune CDMO platform full life cycle service

Based on the medical device registrar system, Liding Medical has established a professional biochemical immune CDMO platform to provide the full life cycle services of entrusted research and development (CRO), entrusted registration (CRAO) and entrusted production (CDMO).

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Registrant

 

Medical devices can be divided into three categories according to risk level:
Class I medical devices (low risk) - filing - filing person
Class II medical devices (medium risk) - registration - registrant
Class III medical devices (higher risk) - registration - registrant

 

1. Medical device registrants and registrants can produce medical devices themselves, or entrust enterprises that meet the provisions of these Regulations and meet the corresponding conditions to produce medical devices.
2. When the registration license (marketing license and production license) is untied, the registrant can produce by itself or directly commission production.
3. The registrant may entrust production across provinces, autonomous regions and municipalities directly under the Central Government, but not across borders;
4. The registrant can entrust multiple enterprises

Entrusted R&D (CRO) service process

The implementation of the medical device registrar system can not only separate the medical device registration certificate from the production license, but also realize the entrusted production of medical devices. At the same time, the R&D of medical devices can also be entrusted.

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The requirements are as follows:

1. Those who independently develop medical devices should have corresponding research and development sites, facilities and equipment;
2. If the research and development of medical devices is entrusted, the entrusted institution shall be ensured to have corresponding research and development sites, facilities and equipment;
3. The registrant shall specify the requirements for the trustee's site, facilities and equipment, and shall inspect the trustee's production conditions and periodically evaluate them before commissioning production.

Delegated Registration (CRAO) Service Process

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CDMO service process

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After-sale service

Online service: telephone service: 24-hour after-sales technical service hotline
Offline service: on site service: provide on-site commissioning reagents and equipment services for customers
Remote support: according to customer needs or technical problems fed back, technical guidance on the use of special conference calls can be provided

Service hotline

Headquarters: building C6, life science and Technology Innovation Park, Qixia District, Nanjing

E-mail:marketing@leading-med. com

Official website:www.leadingmed.cn

Nanjing Liding Medical Technology Co., Ltd

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