The UK government intends to introduce legislation in 2024 that will bring into force strengthenedPost-Market Surveillance requirements (PMS)in Great Britain (GB)ahead of the wider future regulatory framework. The regulations will be based on the World Trade Organisation’sdraft Post-market Surveillance...
The UK government intends to introduce legislation in 2024 that will bring into force strengthenedPost-Market Surveillance requirements (PMS)in Great Britain (GB)ahead of the wider future regulatory framework. The regulations will be based on the World Trade Organisation’sdraft Post-market Surveillance...
The UK government intends to introduce legislation in 2024 that will bring into force strengthenedPost-Market Surveillance requirements (PMS)in Great Britain (GB)ahead of the wider future regulatory framework. The regulations will be based on the World Trade Organisation’sdraft Post-market Surveillance...
The UK government intends to introduce legislation in 2024 that will bring into force strengthenedPost-Market Surveillance requirements (PMS)in Great Britain (GB)ahead of the wider future regulatory framework. The regulations will be based on the World Trade Organisation’sdraft Post-market Surveillance...
根据UK法规的要求,如果产品需要英国批准机构做符合性评估的话,UKCA标志是需要包含批准机构号码的。 7. UKCA对于技术文档有特殊的要求吗?欧盟MDR的技术文档是否可以满足UKCA的要求? 一般来讲,MDR的要求是可以覆盖UKCA的要求,因为UKCA的要求是基于MDD。企业能够熟悉不同法规对应的不同要求是很重要的。 8. I类产品进入...
Note:The UK CT Legislation is currently under review. Any changes to this positionwill be updated as necessary.注意:英国反恐立法目前正在审查中。此职位的任何更改都将根据需要进行更新。 However,it may be that the radiopharmaceutical used in a clinical trial may not be anIMP. There are classes of...
UK draft contingency legislation for drugand device regulation was laid in Parliament last week. MHRA intends to followthe same transitional periods as the EU for the application of MDR and IVDR inthe event of a no-deal scenario. ...
具体见以下网站:https://www.gov.uk/guidance/licensing-procedure-for-electronic-cigarettes-as-medicines#full-publication-update-history 1. 医疗器械和药品共同包装或单独提供(Medicinal Product and Medical Device co-packaged or provided separately) 如果电子烟具和含有尼古丁的药品是分别独立的产品,并且该烟具可能...
The news comes in the wake of the MHRA's consultation on changing UK medicines legislation, which was met with disappointment from pharmacy organisations because of its failure to amend Section 64 of the Medicines Act — the legislation under which pharmacists can be prosecuted for supplying the ...
The MHRA will continue to be responsible for the designation and monitoring of UK Conformity Assessment Bodies. MHRA将继续负责英国合格认证机构的指定和监督。 Further guidance is available on how the MHRA enforces the legislation on medical devices. ...