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MeDC@St is a web-based Online Application System for Establishment Licensing, Medical Device Registration.  It is a centralized system where only one account needs to be created by an applicant to apply for Establishment Licensing and Medical Device Registration.

  • Introduction on Medical Device, please click here!
  • For more information, please click here!
  • MeDC@St FAQ, please click here
  • TO APPLY for Establishment Licence, Medical Device Registration, In-Vitro Diagnostic (IVD) Medical Device Registration, please Create an Account OR Login here! 

WHAT IS MeDC@St?

(1)    MeDC@St is a platform for the industry players to submit their applications for registration of medical devices and licensing of establishments under Act. It is a fully web-based online application system which enables submissions to be made from anywhere in the world, which also provides features that enable access by multiple users. 

HOW TO CREATE A MeDC@St ACCOUNT?

(2)    Figure 2 shows the steps to be taken by an applicant to create a MeDC@St account for the purpose of making application for registration of medical device under Act 737.

(3)    Three main steps are involved in MeDC@St account creation

Step 1:
(i)    An applicant needs to complete MeDC@St Account Creation Form and must provide information required in MeDC@St Account Creation Form which includes

-    Business registration,
-    Establishment name, and
-    A valid email address.

(ii)    User name and password are also required for security purposes. An applicant must provide and reconfirm the password. If the form is completed, applicant must click <create account> button to proceed to next step.

Step 2:
(iii)    Upon creation of a MeDC@St account, a validation email will be sent to the email address provided in the form to activate the account. Applicant needs to log in to his/her email account to validate the email address provided in the MeDC@St Account Creation Form.
Note: A validation email may be received in the SPAM or TRASH folder because of filtering by receiving email server. If the validation email is not received in the inbox, please check in the SPAM or Trash folder.

Step 3:
(iv)    After the email is validated, applicant must login to the system by providing the User Name and Password given in the MeDC@St Account Creation Form during account creation.

HOW TO APPLY

  • http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif How to Apply for Establishment Licence Under Medical Device Act 2012 (Act 737), please click here
  • http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif Guidelines on Medical Device Registration Under Act 737, please click here! http://www.mdb.gov.my/mdb/images//animated%20gif%20update%20%286%29.gif
  • http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif How to Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Medical Device Act 2012 (Act 737), please click here

INFORMATION ON FEE

 A. As prescribe in the Fifth Schedule of the Medical Device Regulation; the application fee is imposed as follows; 

        1. Application Fee for Medical Device Registration

Medical Device

Fee Payable (RM)

A Class A medical device

100

A Class B medical device

250

A Class C medical device

500

A Class D medical device

750

2. Registration Fee 

Medical Device

Fee Payable (RM)

A Class A medical device

-

A Class B medical device

1,000

A Class C medical device

2,000

A Class D medical device

3,000

A medical device that contains a medicinal product

5,000

 
 3. Application Fee for Establishment Licence 

Application Type

Fee Payable (RM)

New application

 

i-           Manufacturer

250

ii-          Authorised Representative

250

iii-         Distributor

250

iv-         Importer

250

Renewal application

 

v-          Manufacturer

200

vi-         Authorised Representative

200

vii-        Distributor

200

viii-       Importer

200

 
4. Licencing Fee for Establishment Licence

Application Type

Fee Payable (RM)

New Licence

 

i-           Manufacturer

4,000

ii-          Authorised Representative

4,000

iii-         Distributor

2,000

iv-         Importer

2,000

Renewal Licence

 

v-          Manufacturer

2,000

vi-         Authorised Representative

2,000

vii-        Distributor

1,000

viii-       Importer

1,000

 

PAYMENT INSTRUCTION

i.        All fees shall be paid 30 days after notifications on the payment advice are notified in the MeDC@St Account. Applications will be dropped from the system if the payment is not received within the specified time.

ii.       All fees shall be paid through bank draft. CASH is NOT accepted. We will not be responsible for the cash sent or brought to our office.

iii.     The bank draft must be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN" and sent to:

KETUA EKSEKUTIF

PIHAK BERKUASA PERANTI PERUBATAN

ARAS 5, MENARA PRISMA,

NO. 26, JALAN PERSIARAN PERDANA, PRESINT 3,

62675 PUTRAJAYA

U/P: UNIT KHIDMAT PENGURUSAN

 

iv.    Information on Application Submission ID and Phone No. of the Contact Person must be written at the back of the bank draft but not in the table (see example below).

v.    The PAYMENT ADVICE must be printed and attached together with bank drafts to indicate the details of payment.

vi.  Payment for application fees and registration fees of different class of medical devices CANNOT be combined in one bank draft. It is adviceable to split the payment in different bank drafts. The fees of maximum of 5 submissions can be combined together in a bank draft.

vii.   The acceptance of the bank draft is subject to the evaluation by our Finance Unit and the recipient bank.

viii.  The bank draft can be returned back to the applicant if payment information is inaccurate.

ix.    A receipt of payment will be issued once the bank draft is accepted. The receipt must be kept as proof of payment.

x.     Please be ensured that the bank draft is still valid when it reaches MDA as bank drafts have validity period i.e. 2 months).

xi.   All fees are non-refundable regardless the decision made by the Authority pertaining to the application made under the Medical Device Act 2012 (Act 737).

 

EXAMPLE OF BANK DRAFT PREPARATION

 

  

Last Updated ( Wednesday, 15 July 2015 )
 
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