Anand K, Saini Ks, Chopra Y, Binod Sk
Department of Pharmaceutical Sciences, Jodhpur National University, Jodhpur, Rajasthan, India.
J Young Pharm. 2010 Jul;2(3):321-5. doi: 10.4103/0975-1483.66804.
'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards, such as, basic standards, group standards, and product standards, are a tool for harmonizing regulatory processes, to assure the safety, quality, and performance of medical devices. Standards represent the opinion of experts from all interested parties, including industry, regulators, users, and others.
“医疗设备”涵盖了从高度复杂的计算机化医疗设备到简单的木质压舌板等所有物品。法规体现了公众对建筑物和设施预期性能的期望，因此代表了公共政策。制定和执行法规的监管机构有权为公众利益制定此项政策，并最终对此向公众负责。标准化有助于构建支撑社会（包括健康和环境）的基础设施，同时促进可持续发展和良好的监管实践。制定国际标准的国际组织包括国际电工委员会（IEC）、国际标准化组织（ISO）和国际电信联盟（ITU）。随着市场全球化程度的不断提高，国际标准（相对于区域或国家标准）对于贸易过程变得至关重要，它确保了出口的公平竞争环境，并确保进口产品符合国际认可的性能和安全水平。标准的制定是为了回应那些明确表示有需求的行业部门和利益相关者。一个行业部门或其他利益相关者群体通常会将其对标准的要求传达给某个国家成员。要被接受进行制定，一个拟议的工作项目必须获得参与成员的多数支持，这些成员会核实拟议项目的全球相关性。监管机构（RA）应提供一种认可国际自愿性标准并对此认可进行公开通知的方法。认可过程可能因国家而异。认可可能通过定期公布监管机构认定符合基本原则的标准清单来实现。总之，国际标准，如基础标准、团体标准和产品标准，是协调监管过程的工具，以确保医疗设备的安全、质量和性能。标准代表了包括行业、监管机构、用户等所有利益相关方的专家意见。
