MDA/GD/0041
December 2016
First Edition
MEDICAL DEVICE
GUIDANCE DOCUMENT
CHANGE OF OWNERSHIP FOR MEDICAL DEVICE
REGISTRATION
Medical Device Authority
MINISTRY OF HEALTH MALAYSIA
MDA/GD/0041
Contents Page
Preface...................................................................................................................... iii
1 Introduction ................................................................................................... 1
2 Scope and application .................................................................................. 1
3 Terms and definitions ................................................................................... 2
4 General requirements……………………………………………………………...4
5 Application process ..................................................................................... .5
6 Completion……………..................................................................................... 6
Annex A (normative) Change Of Ownership For Medical Device Registration
Application Form ….………………………………………………………………………...7
Annex B (normative) Current Authorized Representative Declaration Form.........9
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MDA/GD/0041
Preface
This Guidance Document was prepared by the Medical Device Authority (MDA) to
help the industry and healthcare professionals in their quest to comply with the
Medical Device Act (Act 737) and the regulations under it.
This Guidance Document shall be read in conjunction with the current laws and
regulations used in Malaysia, which include but not limited to the following-
a) Medical Device Act 2012 (Act 737); and
b) Medical Device Regulations 2012.
In this Guidance Document, the following verbal forms are used:
- “shall” indicates a requirement;
- “should” indicates a recommendation;
- “may” indicates a permission; and
- “can” indicates a possibility or a capability.
Irrespective of the requirements of this Guidance Document, MDA has the right to
request for information or material, or define conditions not specifically described
in this document that is deemed necessary for the purpose of regulatory control.
MDA has put much effort to ensure the accuracy and completeness of this
guidance document. In the event of any contradiction between the contents of this
document and any written law, the latter should take precedence.
MDA reserves the right to amend any part of the guidance document from time to
time.
CONTACT INFORMATION
For further information, please contact:
MEDICAL DEVICE AUTHORITY
Ministry of Health Malaysia
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor,
MALAYSIA
Fax: (03) 8230 0200
Email:
[email protected]Website: http://www.mdb.gov.my
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CHANGE OF OWNERSHIP FOR MEDICAL DEVICE REGISTRATION
1 Introduction
Section 5(1) Act 737, no medical device shall be imported, exported or placed in
the market unless the medical device is registered under this Act.
Section 6(1) requires an application for the registration of a medical device be
made by an establishment to the Authority in the prescribed manner. In this
context, the registration of medical device is the responsibility of local
manufacturer or an authorized representative (AR) appointed by manufacturer
having a principle place of business outside Malaysia.
Change ownership of medical device registration is required for reasons such as:
a) Manufacturer outside Malaysia who has set up a company in Malaysia and
intends to obtain the ownership of medical device registration from AR.
b) Replacing of existing AR to new AR by the manufacturer to place the medical
device in the market
c) Merging and acquisition activities
d) Existing AR closed its business
This guidance document is intended to provide guidance on the above
circumstances, in complying with the Medical Device Act and Regulations. This
document is made pursuant to Medical Device Authority (MDA) Circular Letter
No. 3 Year 2016.
2 Scope and application
This guidance document specifies requirements for the change of ownership of
medical device registration in Malaysia and applies to the persons responsible
for registering a medical device under Act 737 as follows–
(a) the manufacturer of medical device as defined in Section 2 of Act 737; and
(b) authorized representative of the foreign manufacturer in the case of a
medical device manufactured in foreign country, as defined in Section 2 of
Act 737.
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3 Terms and definitions
For the purposes of this document, the terms and definitions in Act 737, Medical
Device Regulations and the following apply:
3.1 Authority
The Medical Device Authority established under Medical Device Authority Act
2012 (Act 738);
3.2 authorized representative (AR)
An authorized representative appointed by a manufacturer having a principal
place of business outside Malaysia and such person and authorized
representative being –
a) A person domiciled or resident in Malaysia; or
b) A firm or company constituted under the laws of Malaysia,
and carrying on business or practice principally in Malaysia.
3.3 establishment
Establishment means –
a) A person who is either a manufacturer, importer, or distributor who is
responsible for placing any medical device in the market but does not
include a retailer; and
b) An authorized representative appointed by a manufacturer having a
principal place of business outside Malaysia,
and such person and authorized representative being –
a) A person domiciled or resident in Malaysia; or
b) A firm or company constituted under the laws of Malaysia,
and carrying on business or practice principally in Malaysia.
3.4 manufacturer
Manufacturer means –
a) a person who is responsible for –
(i) the design, production, fabrication, assembly, processing, packaging
and labelling of a medical device whether or not it is the person, or a
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subcontractor acting on the person’s behalf, who carries out these
operations; and
(ii) assigning to the finished medical device under his own name, its
intended purpose and ensuring the finished product meets the
regulatory requirement; or
b) any other person who –
(i) assembles, packages, processes, fully refurbishes, reprocesses or
labels one or more ready-made medical devices; and
(ii) assigning to the ready-made medical device under his own name,
its intended purpose and ensuring the finished product meets the
regulatory requirement,
but shall not include the following persons:
a) any person who assembles or adapts medical devices in the market that
are intended for individual patients; and
b) any person who assembles, packages or adapts medical devices in
relation to which the assembling, packaging or adaptation does not
change the purpose intended for the medical devices.
3.5 MeDC@St
MeDC@St is a web-based Online Application System to submit applications for
registration of medical devices and licensing of establishment under Act. Its
enables submissions to be made from anywhere in the world, which also
provides features that enable access by multiple users.
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4 General requirements
A request to change of ownership for medical device registration shall be made
after the medical device is registered with the Authority and there shall be no
pending applications in the system. Otherwise, the applications would be
required to be completed or withdrawn.
The application for change of ownership for medical device registration shall be
made by the new AR, and only duly completed application forms shall be
submitted to the Authority. The effective date of the change is the date of
approval of the application by the Authority.
The target turn-around-time (TAT) for an application for change of ownership for
medical device registration is approximately 30 working days. All turn-around-
time are estimated and based on complete submissions with all the necessary
accompanying information and documents.
4.1 New AR
The new AR shall provide the following documents:
a) Change Of Ownership For Medical Device Registration Application Form
that is duly completed and signed (please refer Annex A);
b) Establishment license;
c) Letter of Authorisation (LOA) from foreign manufacturer. LOA template may
be refer in MDA/GD/0027; and
d) Official letter from manufacturer to request the change of ownership for
medical device registration from current AR to the new AR. In this letter, the
manufacturer is to provide:
• The effective date of appointment of the new AR. Date should be
before the date of submission of the change application to the
Authority;
• The list of applicable registered medical devices;
4.2 Current AR
The current AR shall provide the following documents:
a) Current AR Declaration Form that is duly completed and signed (please refer
Annex B);
b) Surrender of all applicable medical device certificates to the Authority; and
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c) The current AR shall transfer all distribution and complaints records of the
applicable medical devices up to date of approval of the application by the
Authority to the new authorized representative.
5 Application process
The new AR is responsible for making the application for the change of
ownership for medical device registration. The general application procedure is
described below. AR which is already licensed with the Authority with an existing
MeDC@St account may proceed directly to Step 6.
1. Go to www.mdb.gov.my and click MeDC@St
2. An applicant need 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.
3. 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.
4. 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.
5. An applicant needs to apply for establishment license by submitting
required documents through the system. Please refer to MDA/GL No 2 for
more information.
6. Obtain all required supporting documents as described in Clause 4 of this
Guidance Documents, including Current AR Declaration Form duly
completed by the current AR. Email or fax the documents to the Authority:
Medical Device Authority
Ministry of Health Malaysia
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor,
MALAYSIA
Tel: (03) 8230 0300
Fax: (03) 8230 0200
Email:
[email protected] 5
MDA/GD/0041
6 Completion
The new AR and current AR will be notified of the outcome of the application for
the change of ownership for medical device. The effective date of the change is
the date of approval of the application by the Authority. The access rights of the
current AR to the device listing will cease with immediate effect.
The new AR shall fulfil the duties and obligations under the Act 737 and Medical
Device Regulations.
The current AR shall not be entitled to any refund of the prescribed registration
fee paid. The new AR will be required to pay the service/processing fee RM 500
per medical device registration ID. The validity of registration certificate shall
continue from the initial date of registration of the medical device unless the
registration is cancelled by the Authority before its expiry.
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Annex A
(normative)
Change Of Ownership For Medical Device Registration Application Form
Change Of Ownership For Medical Device Registration Application Form
(In accordance with Circular Letter of Medical Device Authority No. 3 Year 2016 : Change of Ownership for
Medical Device Registration)
Please complete all fields
NEW AUTHORIZED REPRESENTATIVE
Name Of Establishment:
Address :
City: State:
Establishment License Number:
Name of Contact Person: Designation:
Telephone No.: Mobile Phone No.: Email Address:
CURRENT AUTHORIZED REPRESENTATIVE
Name Of Establishment:
Address :
City: State:
Role : Establishment License Number:
Name of Contact Person: Designation:
Telephone No.: Mobile Phone No.: Email Address:
MANUFACTURER
Name Of Establishment:
Address :
City: State:
Role : Establishment License Number:
Name of Contact Person: Designation:
Telephone No.: Mobile Phone No.: Email Address:
DETAILS OF MEDICAL DEVICE(S)
NO MEDICAL DEVICE NAME REGISTRATION NO.
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MDA/GD/0041
Change Of Ownership For Medical Device Registration Application Form
(In accordance with Circular Letter of Medical Device Authority No. 3 Year 2016 : Change of Ownership for
Medical Device Registration)
*Please attached list of medical devices if there are more than 5 medical devices
CHECKLIST
☐ Change of Ownership for Medical Device Registration Application Form
☐ Establishment License (New AR)
☐ Letter Of Authorization (LOA)
☐ Official Letter from Manufacturer
☐ Current AR Declaration Form
☐ Bank Draft Of RM 500 per medical device registration ID
(The bank draft must be made payable to “KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN”)
I, < Name of responsible person >, ID <IC No. or Passport No.> hereby declare that:
i. Accept the appointment by the manufacturer as the new authorized representative for the following
registered medical device(s) and duly acknowledge and accept my duties and obligation as an authorized
representative; and
ii. Comply with all the conditions of approval applicable to the following registered medical device(s) and
conditions imposed;
iii. Will take possession of all distribution and complaints records of the following registered medical
device(s) previously held by current authorized representative up to the date of approval of this change
application by the Authority. I am obliged to maintain these records for the period stipulated in the
regulatory requirements for medical devices safety and performance, Good Distribution Practice for
Medical Device (GDPMD) and provide such records to the Authority in the event of a field safety
corrective action or when requested by the Authority; and
iv. Will fulfil the duties and obligations under the Act 737 and medical device regulations
I hereby attest that the information and attachment provided on this application are accurate, correct, complete and
current to this date.
I understand and acknowledge that it is an offence under Section 76, Medical Device Act 2012 (Act 737) to make
signs or furnish any declaration, or other document which is untrue, inaccurate or misleading.
Signature:
Person Responsible Name:
Designation
Date :
Company stamp :
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MDA/GD/0041
Annex B
(normative)
Current Authorized Representative Declaration Form
Current Authorized Representative Declaration Form
(In accordance with Circular Letter of Medical Device Authority No. 3 Year 2016 : Change of Ownership for
Medical Device Registration)
Please complete all fields
CURRENT AUTHORIZED REPRESENTATIVE
Name Of Establishment:
Address :
City: State:
Establishment License Number:
Name of Contact Person: Designation:
Telephone No.: Mobile Phone No.: Email Address:
MANUFACTURER
Name Of Establishment:
Address :
City: State:
Role : Establishment License Number:
Name of Contact Person: Designation:
Telephone No.: Mobile Phone No.: Email Address:
DETAILS OF MEDICAL DEVICE(S)
NO MEDICAL DEVICE NAME REGISTRATION ID.
*Please attached list of medical devices if there are more than 5 medical devices
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Current Authorized Representative Declaration Form
(In accordance with Circular Letter of Medical Device Authority No. 3 Year 2016 : Change of Ownership for
Medical Device Registration)
DECLARATION BY CURRENT AUTHORIZED REPRESENTATIVE
I, < Name of responsible person >, ID <IC No. or Passport No.> hereby declare that:
i. Will transfer all distribution and complaints records of the following medical device(s) up to date of
approval of this change application by the Authority to the new authorized representative; and
ii. Will surrender all the applicable medical device certificates to the Authority.
I hereby attest that the information and attachment provided on this application are accurate, correct, complete and
current to this date.
I understand and acknowledge that it is an offence under Section 76, Medical Device Act 2012 (Act 737) to make
signs or furnish any declaration, or other document which is untrue, inaccurate or misleading.
Signature:
Person Responsible Name:
Designation
Date :
Company stamp :
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MEDICAL DEVICE AUTHORITY
MINISTRY OF HEALTH, MALAYSIA
Contact Information:
MEDICAL DEVICE AUTHORITY
Ministry of Health Malaysia
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor,
MALAYSIA
T: (03) 8230 0300
F: (03) 8230 0200
Website: http://www.mdb.gov.my
