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Fees and Charges for Product Registration of Medical Devices

1.
Product Registration Fees for Class A (Non-Exempt) Medical Devices
  
 (a)Application fee per applicationS$25
    

2.
Product Registration and Evaluation Fees for Class B, C and D Medical Devices   
  
 (a)Application fee per application        S$500
    
 (b)Evaluation Fees 
    
  (i)        Abridged Evaluation  
   A medical device which has been approved by at least one competent overseas medical device regulatory agency recognised by the Authority is allowed to undergo abridged evaluation. 
     
   Table 1: Abridged evaluation fee per application 
   
Risk classificationFees                   
Class BS$1,800
Class CS$3,500
Class DS$5,700
 
    

 
          
  (i)        Full Evaluation  
   A medical device which has not been approved by at least one competent overseas medical device regulatory agency recognised by the Authority shall be subjected to full evaluation. 
     
   Table 2: Full evaluation fee per application 
   
Risk classificationFees                   
Class BS$3,500
Class CS$5,700
Class DS$11,400
 
    

3.
Product Registration and Evaluation Fees for Combination Products 
  
 The “Drug-device combination” medical device is subjected to a joint evaluation by the Medical Device Branch (MDB) and the Pharmaceutical and Biologics Branch (PBB). 
  
 For Combination products, abridged evaluation* is applicable only if :
    
 -the combination product is approved as a medical device by at least one competent overseas medical device regulatory agency, recognised by the Authority, and  
 -the drug or biologics component had been evaluated and approved by at least one competent drug regulatory agency, as defined by the WHO.
    
  (i)        Table 3: Combination product evaluation fee per application  
   
Evaluation RouteFees                   
Abridged*S$10,000
FullS$75,000
 
    
 Companies who wish to submit "drug-device combination" medical devices for registration are advised to contact MDB prior to the submission. 


Annual Retention Fees for Medical Devices listed on SMDR

1.
An annual fee is payable to maintain a medical device on the Singapore Medical Device Register (SMDR).
  
2.
From 10 August 2011, annual listing fees are payable for Class C and D medical devices. From 01 January 2013, annual listing fees are payable for Class A and B medical devices.
        
   Table 4: Annual retention fee per device listing 
   
Risk classificationFees                   
Class AS$25
Class BS$35
Class CS$60
Class DS$120
 
     

 


Dealer's Licence Fees

1.
From 10 August 2010, companies without valid dealer's licence(s) shall not be allowed to manufacture/ import/ supply medical devices .
  
2.
From 10 August 2010, the following fees (Table 5) shall be payable for:-
 (i)a new application for a dealer's licence, or
 (ii)annual renewal of a dealer's licence 
    
3.Annual renewal licence fees are payable from 01 September 2011 for all dealer's licences.
    
  (i)        Table 5: Dealer's licence fee per application 
   
Licence TypeFees                   
ManufacturerS$1,000
ImporterS$1,000
WholesalerS$1,000
 
    

 


Change Notification and Licence Amendment Fees

 
Dealer's Licence
  
1.
From 10 August 2010, the following fees (Table 6) are payable upon submission of a licence amendment application for a dealer's licence.
    
      Table 6: Fee per licence amendment application for a dealer's licence 
   
Licence TypeFees                   
ManufacturerS$150
ImporterS$150
WholesalerS$150
 
    

 
Product Registration
  
2.
From 10 August 2010,the following fees (Table 7) are payable upon submission of a change notification application for a medical device listed on SMDR.
    
   Table 7: Application fee per change notification application  
   
Risk classificationFees                   
Class AS$25
Class BS$500
Class CS$500
Class DS$500
 
    

3.

From 10 August 2010, the following fees (Table 8) are payable for evaluation of a change notification application involving a technical change.

Evaluation fees shall not be payable for change notification applications that only involve administrative changes.

Please refer to GN-21 Guidance on Change Notification for more information on whether a particular change is categorised as a technical or administrative change.

    
   Table 8: Evaluation fee per change notification application  
   
Risk classificationFees                   
Class B
S$600
Class C
S$1,200
Class D
S$2,300
 
    


Fees and Charges for Certificates

 

 
Certificate of Registration or Certificate of Licence
  
1.
From 10 August 2010, the following fees (Table 9) are payable for a Certificate of Registration of a medical device or a Certificate of Licence for a dealer with the Manufacturer's, Importer's or Wholesaler's Licence.
    
   Table 9: Certificate fees  
   
Request type                        Certificate of Licence      Certificate of Registration
Application fee
S$50S$50
Per registered device
-S$150
Per licence typeS$150-
Per Certificate
S$150S$150
 
    

 
Certificate of Origin, Free Sale Certificate or Export Certificates
  
2.
From 10 August 2010, the following fees (Table 10) are payable for Certificates of Origin, Free Sale Certificate or Export Certificate applications.
    
   Table 10: Certificate fees  
   
Request typeFees                   
1. For new application
(i)       Application fee
S$50
(ii)      Each Device
S$50
(iii)     Certificate for each subsequent country  for the same device (if any)
S$50
2. Duplicate copy of certificate (additional request in remarks)
S$50
 
    


Change of Registrant Fees

1.
Change of Registrant
  
 (a)Application fee for change of registrantS$800
    


Authorisation Route Fees

 
Authorisation Routes
  
1.
From 10 August 2010, the following fees (Table 11) are payable for application for a licence to import or wholesale an unregistered medical device for supply in accordance to the specified authorisation routes below.
    
   Table 11: Authorisation Route Fees 
   
Authorisation Route TypeFees                   
GN-26: Import/Wholesale and Supply on Named-Patient BasisS$500
GN-27: Import/Wholesale and Supply to Private Hospital, Medical Clinic or Clinical Laboratory licensed under the PHMC Act (Cap. 248)  S$500
GN-28: Import/Wholesale for Export or Re-exportS$500
GN-29: Import/Wholesale for Supply for Non-Clinical PurposeS$500
GN-30: Import on Consignment BasisS$100*
 
    
      
 * Standard administrative fees

 


HSA Inspection Scheme

1.
HSA Inspection Scheme (til 2013)
  
 (a)

Fee for amendment to GDPMDS scope (with on-site inspection)

S$1000
 (b)Fee for amendment to GDPMDS scope (without on-site inspection)S$150
    
 (c)

Annual fee for HSA Inspection Scheme

S$1000


Notation

All applicable fees and charges are non-refundable.

From 1 January 2011, only payments through GIRO are acceptable.

A standard administrative fee (currently $100) may be payable when applications are rejected or withdrawn or in other applicable circumstances.


Last updated on 29 Nov 2011 13:21:49
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