Japan MDC plays a cooperative role in work on such revisions with the government, PMDA and related industrial groups. As a result, it is in a strong position to help applicants navigate the related registration process of regulatory approval for medical device and offer a variety of support services for product registration with its expert knowledge of trends in Japan's regulatory environment.
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Japan medical device registrations | j-mdc.com Reviews
https://j-mdc.com
Japan MDC plays a cooperative role in work on such revisions with the government, PMDA and related industrial groups. As a result, it is in a strong position to help applicants navigate the related registration process of regulatory approval for medical device and offer a variety of support services for product registration with its expert knowledge of trends in Japan's regulatory environment.
j-mdc.com
About us - Our message
http://www.j-mdc.com/about.html
Specialized services in regulatory consulting for medical devices. Japan MDC(JMDC) was founded by Mr. Kunihiko Mitsuda and Ms. Nobuko Matsunaga in July 2003 as a government-licensed firm with Marketing Authorization Holder ( MAH. Designated Marketing Authorization Holder ( DMAH. And its Pharmaceuticals and Medical Devices Agency -Japan’s review body for medical products ( PMDA. Obtaining regulatory approval is just part of an overall marketing strategy process rather than being the final goal in itself&#...
医療機器トータル薬事コンサルタントのJapan MDC
http://www.j-mdc.com/indexj.html
1 製造 輸入 の規制から 販売 を主眼とした規制の強化. しかし、日本では新医薬品や新医療機器の薬事申請から薬事承認に対して諸外国と比較して時間がかかる ドラッグラグ や デバイスラグ といわれている問題が深刻化しています。 また、さらに2008年12月には 医療機器の薬事審査の迅速化アクションプログラム を策定し、2009年4月から薬事申請区分の見直しが行われ、以前の後発的医療機器に対する審査は、承認基準をベースにする審査から 実質的同等性 をベースにする審査方式に移行する等の新たな仕組みの導入も行っています。 薬事承認 認証 申請書作成および承認 認証 申請業務.
Security Policy-Japan MDC,LLC
http://www.j-mdc.com/security.html
Establishment of Information Security Management System. JMDC ensures that all directors, officers and employees understand the importance of information security. JMDC establishes Information Security Management System to ensure appropriate management of information assets and continuously seeks to improve it. Management of Personal Information. JMDC will continuously train and educate its directors, officers and employees to raise their awareness of information security and implement an information sec...
JMDC Medical Device News Today
http://www.j-mdc.com/news.html
Medical Device News brings you latest news from well-regarded sources such as press release. Includes news technological developments, robotic surgery, medical devices for use by medical professionals. Medical Device Industry News. August 26, 2016. Medtronic, on Behalf of Its Subsidiary Heartware International, Inc., Announces Offer to Repurchase HeartWare's 3.50% Convertible Senior Notes Due 2017 and 1.75% Convertible Senior Notes Due 2021. August 26, 2016. August 26, 2016. August 26, 2016. Nanoparticle...
Business Licenses for Medical Devices
http://www.j-mdc.com/licenses.html
Business licenses for Medical Devices. Business licenses relating to the manufacture, import, wholesale, retail, rental or repair for Medical Devices in Japan are as listed below. 2) Marketing Authorization Holder (MAH) and Designated MAH (DMAH). 3) Manufacturer for Packaging, Labeling and Storage. 4) Retail/Rental Service license. 1)-(3):Licenses required at the time of submission for approval. 4)-(5):Licenses required after obtaining approval. PMDA: Pharmaceuticals and Medical Devices Agenc. In Case 2,...
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e-Conferences for Advanced Knowledge
http://www.clinicaldevice.com/mall/eConferenceCD.aspx
EConferences on CD—90-Minute Guest Lectures on Device Pre-Approval Issues. 8-15] Bio Risk Mgmt. 09-4] Access Part 11. 09-3] Excel Part 11. 09-17] GHTF StudyGrp 5. 09-7] Device Directive Recast. 06-8] CE Literature Route. 08-9] Intro to FD&C Act. 08-4] FDAAA of 2007. 08-2] Patient and Cash Flow. 07-4] FDA Site Inspections. 06-7] Registries - Investigator Viewpoint. 07-8] Data Monitoring Committees. 08-6] Getting to Reimbursement. 07-7] Section 522 Studies. 06-7] Registries - Investigator Viewpoint. The ne...
英文校正
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英文校正 ネイティブチェック 英文編集 プルーフリーディング 英文添削. ミツダ クニヒコ様、 Japan MDC, LLC. 英文校正のお見積りは、ご依頼の原稿を information@pgelanguage.co.jp. 169; 2010 ネイティブチェックのPGE Language.
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Japan medical device registrations
Japan’s Pharmaceutical Affairs Law ( PAL. Recent years have seen an expansion of medical research and development activities in Japan, the United States, the European Union, Asia and other regions, as well as population aging and advanced technological innovation in fields such as biotechnology and new medical devices. Ministry of Health, Labour and Welfare) implemented a major revision of the Pharmaceutical Affairs Law ( PAL. In 2002 and reformed the related approval. With the product license-holder fun...
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