Importing Healthcare Products into Singapore Part 4: Importing Medical Devices
DEFINITION OF MEDICAL DEVICES
Medical Device is understood as “Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related articles used for achieving a medical function, that is diagnostic, preventive or therapeutic in nature but without involving pharmacological, immunological or metabolic action”.
HPA classifies the medical devices into four classes depending on the risk involved, which is assessed based on factors including duration of use, invasive or implantable, involves any drug or biological compound etc.
| 类 | 风险水平 | Device examples |
| A | Low Risk | Surgical retractors / tongue depressors |
| B | Low-moderate Risk | Hypodermic Needles / suction equipment |
| C | Moderate-high Risk | 肺呼吸机/骨固定板 |
| D | High Risk | Heart valves / implantable defibrillator |
Since August 2011 according to the Health Products Act, all medical devices, including those licensed under Radiation Protection Act, will need to be registered with HSA before supply unless they are for clinical trials, are “custom made” medical devices, and/or are class A devices on the exemption list. Certain low risk medical devices, due to the low risk associated with their use, are exempted from product registration. However exemption from product registration does not relieve the dealers of such devices from their responsibilities under the法案and规定.
自2012年1月1日起：所有医疗器械无论其风险分类如何（除非豁免产品注册），进口和供应必须符合下面的标准之一：
- Listed on the Singapore Medical Device Register (SMDR);
- Listed on the Transition List; OR
- 通过其中一个授权路线授权。
For medical devices imported solely for re-export or manufactured solely for export, the Authority shall be notified of their importation and exportation.
医疗设备的注册
Health Products Act requires that the product owner and its registrant must register the product with HSA in order to be listed in the Singapore Medical Device Register (SDMR). SDMR listing must occur before the device is to be supplied to the local market. The product registration requirement would only be applicable to Class A sterile, Class B, Class C and Class D medical devices to be supplied in the domestic market.
A company that is registered with Accounting and Corporate Regulatory Authority (ACRA) can apply for a product registration. It may be the Singapore subsidiary of the product owner (principal manufacturer) or a local company that is authorized by the product owner to submit the product registration application.
产品所有者必须记录设备的预期目的，并通过按照所提供的分类规则确定设备的风险分类Regulatory Guidance of HSA. Where a particular device qualifies under more than one risk class, the highest risk class must be taken into account.
注册程序
Applications must be submitted online via医疗设备信息和通信系统（医疗服务）.
ACRIC（客户注册和识别服务）公司需要访问医疗服务。一旦授权，通常需要3-4个工作日，通过克里斯，员工或服务提供商可以使用他们的Singpass或HSA引脚访问医疗机构。它不会产生任何费用。
After obtaining a CRIS account, the company must apply for a Registrant’s Account. Only Singapore registered companies are allowed to obtain a Registrant’s Account and the process takes 7 working days.
A类医疗设备
For the registration of class A medical device, submission in CSDT format is not required. The application process is simple and has four steps – Application Submission, Screening, Review and Regulatory Decision by Authority. The application must be accompanied by the following:
- Original English copies of labels and packaging
- 使用说明
- 患者信息传单（如果适用）
- Promotional materials
- 灭菌验证报告（如适用）
- Certification on medical device metrology (if applicable)
- 电气安全标准认证（如适用）
类B, C, D Registration
Product registration application must be prepared in accordance with ASEAN Common Submission Dossier Template (CSDT) in English and must be accompanied by all relevant certificates, reports and copies of labeling etc., as annexure. Depending on the evaluation route chosen by the owner/registrant, the extent of details required will vary.
A Pre-submission consultation may be necessary if there are specific issues or when there is uncertainty as to whether the application dossier will meet the prevailing submission requirements.
将筛选申请，以获取信息或文件的任何主要缺乏，如果已确定任何此类缺乏注册人，将发送输入请求以填补空白。如果注册人未能提供所有请求的信息，或者提交的信息不完整，缺陷或包含未经请求的信息，则申请将被拒绝。同样没有以规定的格式制作的应用程序，寻求非医疗设备的产品注册或不恰当的课程和评估也将被拒绝。
Evaluation will commence after payment of evaluation fees. If a product has been evaluated and obtained market clearance in at least one of the GHTF founding member countries, abridged evaluation route is applicable. All other class B, C, and D medical devices must undergo the full evaluation route.
从r可以要求额外的信息egistrant at this stage and must be submitted within 14 days. When such information cannot be provided within the stipulated time the registrant may approach the Authority to ask for additional time. If the registrant fails to furnish the requested details within the mutually agreed time frame then the application will be rejected.
在评估时，如果权限确定为“可注册的产品”，则注册人可以提交申请书列出新加坡医疗设备登记册（SMDR）的医疗设备。注册人必须遵守当局奠定的所有职位登记条件。
Product registration is done electronically hence no hardcopy certificates are available. If the Registrant wishes to have a hardcopy of the registration, the Registrant may request for a hardcopy certificate upon payment of a fee. An annual fees is payable for retaining the products registered in the SMDR.
在提交申请后的产品注册时转弯时间因产品类别和评估类型而异。对于A类产品，它是60个工作日和B类，C和D产品，其范围从100到310个工作日。
医疗设备进口许可证
A company importing medical devices into Singapore is required to hold an importer’s license. Applications for Importer’s Licences are to be submitted via the on-line system, MEDICS@HSA.
A Key contact person appointed by the company would be the person, who will liaise with the Authority on all issues regarding applications submitted by the company including input request on applications.
Application must be accompanied by certificate of Good Distribution Practice for Medical Devices in Singapore (GDPMDS) or ISO 13485 certificate, with scope of storage and distribution included and a list of exempted Class A medical devices imported.
对于不制造或进口豁免医疗设备的公司来说，应提供关于公司信笺上的宣言函。GDPMDS认证将由新加坡认证委员会认可的公认认证机构进行。
以下活动不需要GDPMDS认证：
- Import for re-export only
- Import for non-clinical use only
在上述例外情况下，应提交宣言代替证书。
每辆被许可人都必须在何时对以前宣布的任何详情发生变更时通知管理局。
许可证有效期为12个日历月份，许可证续签的电子邮件通知提醒将从许可证抵达前的被许可人60日历日发出权限。必须在许可证到期日之前提交40个日历日内的申请。
请注意，仅在空中或海港的FTZ内行进医疗设备活动的公司，不需要由HSA许可。
The importation of medical devices into Zero-Rated GST warehouses will require a medical device Importer’s License. When exporting (which is a wholesale supply) these medical devices, a medical device Wholesaler’s License is required.
Obligation Of the Importers
进口商有以下强制性义务履行：
- 维护进口和供应记录
- Maintain records of complaints
- 向HSA报告缺陷和不利影响
- 通知HSA关于现场安全校正操作
- Follow prohibition against false or misleading advertisement
For information about importing other types of healthcare products into Singapore, refer to the following guides: