Guideline for Technical Review of Implantable Drug Delivery Device Product Registration
This Guideline is intended to help and instruct the registration applicant to prepare application dossiers for implantable drug delivery device registration, so as to meet the basic requirements for technical review. It also helps the technical reviewing institution to conduct a scientific and standardized review of such products, improving the quality and efficiency of the review.
The Guideline is the general requirements for the application dossiers for implantable drug delivery device registration. The applicant shall supplement and detail the contents of the registration application dossiers based on the characteristics of specific products. The applicant shall also determine whether the specific content of this Guideline is applicable based on the features of specific products and specify reasons and relevant scientific basis if not.
This Guideline is a guiding document for the applicant and the reviewer, which excludes the administrative matters involved in registration approval and shall not be enforced as regulations. It shall be used on the premise of complying with relevant regulations. Other methods (if any) that can meet the requirements of relevant regulations may also be adopted, but detailed research and verification data shall be provided.
This Guideline is formulated based on the current regulations, standard system and present cognitive level. Along with constant improvement of regulations and standards as well as continuous development of science and technology, the relevant content in this Guideline will be revised timely.
CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司，作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商，CODEX科译拥有更多的医学资深语言专家，能实现40多种语言对的互译，接受更高难度的医学领域的项目挑战，并在最短时间内适应以给出最合理的解决方案。保证最高质量，100%按时交付，高效、完善的售后保障是CODEX科译给客户的用心承诺。CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.