countries. legco.gov.hk legco.gov.hk 3.1.2 消委會明白,監察這些儀器將會為監管機構帶來重擔,因此,消委會建議, 尋求醫療儀器登記的申請㆟在登記程序㆗須宣誓說明有關產品與在GHTF創始成員國獲准銷售的產品相同。 legco.gov.hk legco.gov.hk The framework proposed in this paper is largely in line with...
NOTE 1 This ‘natural or legal person’ has ultimate responsibility for ensuring compliance with all applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be made available or sold. NOTE 2 The manufacturer’s responsibilities are described ...
The regulatory requirements of some countries do not, at this time, align fully with this guidance. Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this guidance document. Comments or questions should be directed to either the Chairman or Secretary of GHTF Study Group ...
cenorm.be Web Site: http://www.cenorm.be/cenorm/index.htm GHTF SG3 Training : Toronto May 14-16, 2009 32 Sources of Standards - CENELEC CENELEC is a non-profit technical organization set up under Belgian law and composed of the National Electrotechnical Committees of 28 European countries...
This agreement will pave the way for a lasting peace between the two countries. 3)他们通常要等你开始放松警惕,才提出他们的要求。(let one’s defenses down) They usually don’t mention their requirements until you are beginning to let your defenses down. 4)要有勇气面对自...
Another way to look at this is to think of your passport . That is usually proof that you're from a specific country. Some people even have two passports because they are from two countries! Some count ries let you have dual citizenship!