Product Name
Covid related IVD medical Device (Class D) / 新冠IVD产品（D类别）
Service
HSA IVD Medical Pre-Market Approval Registration Service / 新加坡卫生科学局入市注册服务
Service Detail
– Serving as your in-country Registrant to liaise with HSA throughout the registration process
成为贵司的注册代理，负责全程与卫生科学局的有效沟通
– Helping to determine your device classification and registration route
帮助您辨识的产品分类和与其合宜的注册途径
– Assisting with the preparation of the HSA submission dossier
协助预备与整理提交的档案
– Identifying opportunities for authorization and documentation in other markets for more efficient registration in Singapore
找出您产品在国际市场上相关的有利文件，以便推进更高效地注册
– Proposing an optimal device grouping strategy to expedite registration processes and reduce unnecessary costs
提供最佳产品分类注册策略以加快注册流程并降低不必要的成本
– Assisting with post-market surveillance, vigilance, adverse-event reporting, if required
协助受理所注册产品上市后监督、警惕、不良事件报告的事宜
Estimate Activity Duration
3 – 6 Months （月）
Other Detail
Complimentary Registration Service for Self-Testing Market Approval (MOH) if product applies.
提供免费的自测注册服务 – 卫生部
Fees
USD 45,000
Payment Term
50% payment before commencement of registration with HSA
提交材料申请以先预付全款的50%
50% payment upon provision of proof of successful registration with HSA
在提供通过注册的证据后支付剩余款项
*No Exclusivity or Distribution Rights will be granted to Alcotech in the registration service.
此注册服务不含任何形式的独代与销售权