Medical Device GMP Certification
Release time:
2024-10-25
According to the spirit of the national food and drug supervision and administration and the construction of a clean and honest government on December 26, 2013, China will fully implement the production quality management standard in the medical device industry.
Good Manufacturing Practice (GMP) for Medical Devices
The whole process of GMP compliance service is in place in one step.
The Necessity of GMP Certification in Medical Device Factory
According to the spirit of the national food and drug supervision and administration and the construction of a clean and honest government on December 26, 2013, China will fully implement the production quality management standard in the medical device industry. In 2014, the State Food and Drug Administration issued the "Notice on Matters Related to the Implementation of Medical Device Production Quality Management Regulations" (No. 15 of 2014), in accordance with the principles of risk management and classification promotion, it determined different types of medical device manufacturers. The specific time limit requirements for the implementation of the "Regulations. By the end of 2015, all third-class medical device manufacturers in my country must meet the requirements of the "Medical Device Production Quality Management Regulations" (hereinafter referred to as the "Regulations"); since January 1, 2018, all medical device manufacturers must meet the "Medical Device Production Quality Management Regulations" requirements.
The Importance of GMP Certification in Medical Device Factory
Standardize the production process of medical device manufacturers and ensure the standardized operation of products; |
Standardized system to facilitate international integration;
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Ensure the quality of medical device products, and ensure the safety and effectiveness of products used by the people; |
Improve the technological level of medical device manufacturers and improve the comprehensive competitiveness of medical device products. |
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Medical Device Factory GMP Certification Service Process
Durst Medical Device GMP Certified Specialist:
5. Durst advantage:
1: the medical device industry regulations, standards of accurate understanding and mastery
2: has a wealth of medical device GMP certification consulting and training experience and on-site technical service experience;
3: professional team, a number of foreign industry experts guidance.
4: one-stop, all-round technical services, etc.
Durst Success Story (partial):
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Shenzhen Jianke Industrial Co., Ltd. |
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Yangzijiang Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd. |
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Shenzhen Zhonghe Hyderway Biotechnology Co., Ltd. |
For more information, please contact Durst400 9932 368
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Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
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