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.
|Class||Risk Level||Device examples|
|A||Low Risk||Surgical retractors / tongue depressors|
|B||Low-moderate Risk||Hypodermic Needles / suction equipment|
|C||Moderate-high Risk||Lung ventilator / bone fixation plate|
|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 Act and Regulations.
With effect from 1 January 2012: All medical devices regardless of its risk classification (unless exempted from product registration), to import and supply must meet one of the criteria below:
- Listed on the Singapore Medical Device Register (SMDR);
- Listed on the Transition List; OR
- Authorised via one of the Authorisation Routes.
For medical devices imported solely for re-export or manufactured solely for export, the Authority shall be notified of their importation and exportation.
REGISTRATION OF MEDICAL DEVICES
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.
The product owner must document the intended purpose of the device and determine the risk classification of the device by following the rules of classification as provided in the Regulatory Guidance of HSA. Where a particular device qualifies under more than one risk class, the highest risk class must be taken into account.
PROCEDURE FOR REGISTRATION
Applications must be submitted online via Medical Device Information and Communication Systems (MEDICS).
A CRIS (Client Registration and Identification Service) account is required for companies to access MEDICS. Once authorization has been granted, which normally takes 3-4 working days, through CRIS, employees or service providers can then access MEDICS using their SingPass or HSA PIN. It does not incur any charges.
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.
Class A Medical Device
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
- Instructions for use
- Patient information leaflet (if applicable)
- Promotional materials
- Sterilization validation report (if applicable)
- Certification on medical device metrology (if applicable)
- Certification of electrical safety standards (if applicable)
Class 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.
The application will be screened for any major paucity of information or documents and if any such paucity is identified registrant will be sent an input request to fill the gaps. If the Registrant fails to provide all requested information, or the submitted information is incomplete, deficient or contains unsolicited information, the application will be rejected. Likewise applications not made in prescribed format, application seeking product registration for non-medical devices or via inappropriate class and evaluation will also be rejected.
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.
Additional information may be requested from the registrant 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.
On evaluation if the authority determines a product to be ‘registrable’ the Registrant may submit an application to list the medical device on the Singapore Medical Device Register (SMDR). The registrant must comply by all post registration conditions laid by the Authority.
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.
The Turn around time for the Product registration after submission of application varies depending on the class of the product and type of evaluation. For Class A product it is 60 working days and Class B,C and D products it ranges from 100 to 310 working days.
MEDICAL DEVICE IMPORT LICENSE
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.
For companies that do not manufacture or import class A exempted medical devices, a letter of declaration made on company letterhead should be provided. Certification to GDPMDS is to be performed by recognized certification bodies that are accredited by the Singapore Accreditation Council.
GDPMDS certification is not required for the following activities:
- Import for re-export only
- Import for non-clinical use only
In the case of the abovementioned exceptions, a declaration should be submitted in place of the certificate.
Every licensee is required to notify the Authority whenever there is a change to any particulars formerly declared.
A License is valid for 12 calendar months an email notification reminder for license renewal will be sent from the Authority to the licensee 60 calendar days before the expiry of license. Application for renewal must be submitted 40 calendar days prior to the expiry date of license.
Please take note that companies that only conduct trans-shipment of medical devices activity, within the FTZ of the air or seaports, are not required to be licensed by HSA.
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
The importers have the following mandatory obligations to fulfill:
- Maintain records of import and supply
- Maintain records of complaints
- Report defects and adverse effects to HSA
- Notify to HSA concerning field safety correction actions
- Follow prohibition against false or misleading advertisement
For information about importing other types of healthcare products into Singapore, refer to the following guides: