[COMPANY LETTERHEAD]
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Singapore 138667
Top of Form
APPLICATION FOR HSA PIN (MEDICS) BY A LOCAL COMPANY
1. I,*Dr/Mr/Mrs/Miss/Mdm______
(name of applicant), ______(NRIC/Passport), being a sponsor, or partner, or Company Director, or Company Secretary, or General Manager for ______(name of local company1) hereby confirm that the undermentioned person(s) employed by ______(name of oversea company) will be transacting with HSA and requires a HSA PIN.
HSA PIN Account Holder(s) (pls indicate if there is more than one)
Name 1 : / ______Passport No: / ______
The detail is attached from pg 3 onwards.
2. I declare that the particulars given in this application are true. I also undertake to notify HSA, of any change in the information provided in this application within 7 working days.
Yours faithfully,
Signature of Applicant and Date / (Local Company Stamp)
Designation:
1 The name of applicant must be listed with ACRA (formerly known as RCB). Enclose photocopy of applicant’s NRIC /Passport.
This person named below will be the contact for any correspondence on CRIS-related matters, including the notification of approval of this application.
Name : / ______Office Tel No : / ______
Office Contact Email: / ______
/
APPLICATION FOR HSA PIN (MEDICS) BY A LOCAL COMPANY
Ref No. (to be filled in by HSA)[A] LOCAL COMPANY INFORMATION
Please fill up the following:
1. Company Name2 registered in ACRA:
2. ACRA registration number:
3. Company Address:
Block/No / Floor No – Unit# / –Street Name
Building/Estate Name
Postal Code4. / Office Tel: / Fax No:
1 MEDICS is an acronym for “Medical Device Information & Communication System”, a portal of e-services developed by HSA’s Medical Device Branch.
2 Company name as stipulated in the ACRA’s Business Profile. Enclose photocopy of ACRA’s Business Profile.
[B] FOREIGN COMPANY INFORMATION
Please fill up the following:
1. Name of Foreign Company1:
2. Company Address:
Street Name
3. / Office Tel No.:4. / Fax No.:
5. / Email Address:
[C] PARTICULARS OF HSA PIN ACCOUNT HOLDER
You may make additional copies of this Section of the Form if applying for more than one HSA PIN account.
1. Name:
2. Passport No. 1:
3. Email Address:
4. / Tel (O):5. / Country:
6. / Effective Date:
(dd/mm/yyyy)
1. I hereby declare that I would only use the account to carry out transactions for the following foreign company and would not divulge, share or compromise the HSA PIN with others.
Signature of HSA PIN account holder:Date:
1 Enclose photocopy of HSA PIN Account holder’s Passport.
NOTES:
1. This form may take you 10 minutes to fill in.
2. The following completed form and supporting documents are required for submission for this HSAPIN (MEDICS) by a Local Company:
i) Application form including:
a) A cover letter with local company letterhead
b) Part A: Local Company Information
c) Part B: Foreign Company Information
d) Part C: Particulars of HSAPIN holder(s)
e) This notes page with For Official Use section
ii) Photocopy of ACRA’s RCB Business Profile for the Local Company
iii) Photocopy of applicant’s NRIC/Passport from the Local Company
iv) Photocopy of HSAPIN holder’s passport
Note: Incomplete application will not be processed. No fee is required for this application.
3. Please mail your completed form and supporting documents to:
Attn: HSA PIN Administrator (MEDICS)
Health Sciences Authority
11 Biopolis Way, #11-01 Helios
Singapore 138667.
4. You will be notified of the approval of HSA PIN application by email within 7 working days. For enquiries, please contact HSA PIN Administrator at (65) 6866 3497.
5. Once the HSA PIN has been approved, you can gain access to HSA’s CRIS and MEDICS online systems. The access to MEDICS requires a CRIS Company Account, along with authentication of login/password to ensure the highest security level for your transaction and information.
Note: Upon HSA PIN approval, it is important that HSA PIN holder informs the CRIS Company Administrator(s) to log into CRIS management module e-Service (http://www.hsa.gov.sg/publish/hsaportal/en/services/cris.html) to authorise the type of MEDICS e-Services for this HSA PIN holder to access. A range of MEDICS e-Services, listed in Appendix A, are available based on the CRIS Company and Establishment business activity. HSA PIN holder can only be a drafter in the application and can only access to one or more of the following e-services in MEDICS:
· Pre-market Clearance application
· Registration of Higher risk device
· Workbench
FOR OFFICIAL USE ONLY
Status/Remarks : ......
Date and Signature of the officer : ......
Appendix A :
Range of MEDICS e-services granted to each Establishment and CRIS MEDICS Company Account
MEDICS e-Services / Registrant / Manufacturer / Wholesaler / Importer
(1) APPLY@MEDICS
Establishment Registration1
· Establishment/Dealer Licence Application / √
(Account) / √
(Licence) / √
(Licence) / √
(Licence)
Product Registration
· Market Clearance Application (Registration for Higher Risk Medical Device) / √
· Notification Application (Product Registration for Low Risk Medical Device) / √
Certificates
· Free Sales Certificate Application / √
· Export Certificate Application / √
(2) WORKBENCH@MEDICS
One-Stop Application & Status Enquiry
· Workbench / √ / √ / √ / √
(3) CHANGE@MEDICS
Licence/Listing/Application Management
· Amendment of Licence/Notification / √ / √ / √ / √
· Cancellation of Licence/Registration/Notification / √ / √ / √ / √
· Renewal of Licence/Registration/Notification / √ / √ / √ / √
· Supplementary for Pre-Market Clearance Application for Higher Risk Medical Device / √
· Withdrawal of Application / √ / √ / √ / √
(5) SINGAPORE MEDICAL DEVICE REGISTER
Public Enquiry on Medical Device
· SMDR (open for public access) / - / - / - / -
1
HSA PIN MEDICS Application_ v4.0
Revised on 16 July 2015