QP Declaration of Conformity is a formal declaration of GMP conformity in the clinical phase of the product in the EU and PIC/S Member States, which has the effect of legal recognition, and the inspection in the clinical phase is equivalent to the official inspection. The QP shall be responsible for the GMP implementation results of the enterprise. In the clinical phase, the QP conformity statement can be submitted as GMP conformity data in the clinical phase to the EU or PIC/S countries as the basis for GMP conformity. The QP declaration of conformity is also a very good proof of compliance before the enterprise has not obtained the official GMP certificate overseas. According to the EU QP regulation, except in special circumstances, the QP declaration of conformity needs to be checked remotely, the enterprise or local government provides proof, and the QP should go to the site for review.
2024
10-25
Drug Marketing Holder System/MAH
"The medical device registrant system issued and implemented by the State Drug Administration has solved the actual dilemma of landing products for science and technology start-up enterprises and technology research institutions, solved the problems of idle production sites, equipment and other resources before listing and unsaturated work of professional manufacturing personnel, and avoided the waste of resources caused by the difference between pre-market trial production and post-market mass production scale, and the occupation of a large amount of infrastructure funds before listing approval.
2024
10-25
Medical Device GMP Certification
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.
2024
10-25
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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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