Common Submission Dossier Template
Found 6 free book(s)Guidance on Preparation of a Product Registration …
www.asean.orgAn executive summary shall be provided with the common submission dossier template, which shall include the following information:- an overview, e.g., introductory descriptive information on the medical device, the intended uses and indications for use of the medical device,
Home - Food and Drug Administration
www.fda.gov.ph(Common Submission Dossier Template) based on the provisions of AMDD. With the implementation of AO 2018-0002, the FDA through the Center for Device Regulation, Radiation Health and Research (CDRRHR) is also mandated to release list of medical devices per classification based on the classification set forth in the ASEAN AMDD.
ASEAN 医療機器指令の概要と各国の 対応状況向調査 - JETRO
www.jetro.go.jpプロセスが一定程度整合されること、統一申請様式(Common Submission Dossier Template、 以下CSDT)を活用した申請が可能となることは、労力・時間・コストを削減する点で大き なメリットとなります。一方、現状では、各国のAMDD へ準拠した法令や許認可プロセス
Guidance on the format of the risk management plan (RMP) …
www.ema.europa.euthe eCTD dossier of the supporting documents or PSURs , when applicable. Throughout the RMP template, eCTD data/submissions should be read as eCTD or CTD data/submission, corresponding to the type of submission to the competent authority. Specific requirements for different types of initial ... Where the submission of a common, consolidated RMP ...
Validation issues frequently seen with initial MAAs
www.ema.europa.euIf not, the applicant may use one of the proposed (invented) names or the common name (or scientific name), together with a trademark or the name of the Marketing Authorisation Holder. In both cases, the NRG review is required. Once the NRG review outcome is available, the dossier may be updated as required.
ASEAN MEDICAL DEVICE DIRECTIVE
asean.orgdevice regulations, common technical documents and the progress made in implementation. HAVE AGREED as follows: ARTICLE 1 GENERAL PROVISIONS (1) Each Member State shall undertake all necessary measures to ensure that only medical devices which conform to the provisions of this ASEAN Agreement on Medical Device Directive (hereinafter referred to as