REGISTRATION OF

MEDICAL DEVICESUBMISSION & APPLICATIONBy IDAMAZURA IDRIS

MEDICAL DEVICE AUTHORITY

Introduction

� Medical device: regulated item under the Medical Device

Act 2012 (Act 737) and its regulation

� The objective: to ensure medical devices enter Malaysia

market are safe, effective and perform as intended by the

manufacturer

� Pre market clearance/approval is required before

importation, exportation and placement of medical device

in the market – REGISTRATION OF MEDICAL

DEVICE (Section 5 of Act 737)

Application of Medical Device

Registration - Requirements

�The requirements are stipulated in

� Medical Device Act 2012 (Act 737) –

• Section 6: Application for registration of medical device

� Medical Device Regulation 2012 –

• Regulation 5: Application for registration

Application of Medical Device

Registration - Procedures

• An application shall be made to the Authority in the

FORMs to be determined by the Authority [Reg. 5(1)].

• An application shall be accompanied with the following:

a) Application fee as specified in the Fifth Schedule;

b) Document or information as specified in the FORMs;

c) Other additional information, particulars, document on

application or sample of the medical device [Reg. 5(2)];

• (c) shall be submitted within 90 days from the date of

request by the Authority [Reg. 5(3)]

Reference documents

• Guidance documents to be referred:

i. Classification of medical device & in vitro medical

device;

ii. Grouping of medical device;

iii. Essential principles of safety & performance of medical

device (EPSP);

iv. Common Submission Dossier Template;

v. Declaration of Conformity; and

More to come….

Documentation for medical

device registration

Class Document to be submitted

Class A, Only DoC

Class A(S)Report/cert on the validation of

sterilization process and DoC

Class A(M)Report/cert on the validation of

measuring function and DoC

Class BCSDT and its supporting

documents and DoC

Class CCSDT and its supporting

documents and DoCClass D

A

B

C

D

R I S K

Comprehensiveness of the information required

The Registration Form

• One of the MeDCASt modules - Medical Device Registration.

• An on-line form – can be accessed from the web.

• The form is divided into 8 parts–a) General Information

b) Grouping of Medical Device

c) Common Submission Dossier Template (CSDT) and its supporting documents

d) Details of Importer/Distributor

e) Post-Market Vigilance History

f) Information on usage, installation and maintenance

g) Declaration of Conformity

h) Declaration of Application Submission

• Information & supporting documents must be provided as required in the form.

General Information

• The information required in this part;• Role of establishment

• Product Placement (Import, export or placement in the market)

• Type of medical device (IVD or general medical device);

• Class of device and its classification rule (Justification of device classification);

• Name of medical device (Generic, Manufacturer Specified and Brand);

• Intended use;

• Device description;

• Details on drug (the active ingredient, the composition, indication) –applicable to the drug-device product;

• Name of manufacturer and country-of-origin;

• GMDN category and code;

• Pre-market clearance /approval.

• The information must be keyed-in, chose and checked the field provided in the Form

Grouping of medical

device

• Information on grouping of medical device to be registered;

• The grouping should be done in accordance to the Rule of Grouping

as stipulated in 2nd Schedule of the Regulation;

• Single

• System

• Family

• Set

• IVD Test Kit

• IVD cluster

CSDT and its supporting

documents

• CSDT and its supporting documents are required for

registration;

• The elements are as listed in the on-line form;

• Submission of the documents is done by way of uploading the

*softcopy of the documents into the system;

• The size of the document should not exceed 15MB per

uploading;

• Multiple Uploading is allowed in an element – 1 document can

be uploaded in 1 time

*only PDF format is accepted

Elements of CSDT

• Executive summary

• Relevant essential principles and rule used to demonstrate conformity

• Description of medical device

• Summary of design verification and validation documents

• Pre-clinical studies

• Software validation studies

• Medical device containing biological material

• Clinical Evidence

• Use of existing bibliography

• Medical device labelling

• Risk analysis

• Manufacturer information

Preparation of CSDT

• CSDT is a compilation of objective evidences to show compliance to the relevant EPSP and other requirements specified by the Authority;

• It should be prepared in accordance with requirements stipulated in Appendix 2 of Third Schedule of Medical Device Regulation 2012;

• The documentation is depending on the EPSP and CSDT elements that is applicable to the device;

• Should be verified and validated by the CAB.

Note: not all principles of EPSP and CSDT elements are applicable to a medical device

Details of

importer/Distributor

• Information required including

• Establishment details (name, address and business

registration number)

• Contact person details (name, telephone, fax, email) - Copy

of IC must be uploaded

• Role of Establishment

• Status of Establishment Licence

• The purpose of this part is to ensure the traceability of the

device.

Post-market vigilance

history

• Information on the history of post-market vigilance;

• Recalls status

• Reportable adverse incidents

• Banning or restriction of the medical device in other

countries

• Pro-active post-market surveillance study conducted

Information on usage,

installation and maintenance

• Information on the usage; whether the device is for

• Single use

• Professional use

• Home use

• Information on the requirements of installation and

maintenance;

Declaration of conformity

• An attestation of conformity to the EPSP and compliance

to the requirements to the Act and its regulation.

• Pre-requisite for medical device registration.

• The preparation of DoC should be in accordance to

Appendix 3 of Schedule 3 in Medical Device Regulation

• The DoC need to be signed and uploaded in the system

Declaration of Application

• Declaration on

• The correctness and validity of the information provided

• The undertaken of responsibility on any matters pertaining

to the post market surveillance or vigilance

• The undertaken of responsibility on any legal matters or

implication s pertaining to medical device registration

The

application

of medical

device

registration

– The flow

Start

Go to MDA web page

Create an account

Successful?

Validate the email

address provided

Log in to the system

Choose Medical Device

Registration ModuleComplete the form

Upload the supporting

documents

Upload the DoC

Make application

declaration

Submit the

application

End

No

Yes

Account creation

Start

Receive application & notify

the receipt of application

Verify the class & group

of medical device

Satisfy?

Request for

application feePaid?

Notify the receipt of payment

Evaluate the application and

verify the documents

Satisfy?

Request for registration fee

Paid?

Notify the receipt of payment

and register the medical

device

Return the

application to the

applicant for further

information

*The application

will be dropped

from the system

End

YesNo

Yes

Yes

Yes

No

No

No

The registration of

medical device –

The flow *If the payment is not received within the specified time (30 working days)

Return of the application

• Due to

• lack of information,

• wrong document attached,

• certificate is not valid,

• data is not well presented, and etc

• Additional information must be provided to the Authority

within 90 days,

• Otherwise, the application is deem to be withdrawn

The registration of medical

device

• Upon THE APPROVAL by the Authority, the medical

device will be REGISTERED in the Medical Device

Register for the period of 5 years (Section 8 of Act 737 and

Reg. 6(2) of Medical Device Regulation 2012)

• The registration number will be assigned and the

certificate of registration will be issued (Section 7(1) of Act

737)

• The conditions of medical device registration will be

imposed (Section 8 of Act 737)

Changes of medical device

• Changes pertaining to the device must be notified to the

Authority – a condition for registration.

• 2 categories of changes:

i. Minor changes – doesn’t affect safety and performance,

ii. Major changes – affect safety and performance,

• If major changes, conformity assessment need to be conducted.

• The evidence of conformity for major changes may be required

by the Authority at any time.

Transition

• Transition period is given for 2 years from the appointed

date (Section 80 (1) of Act 737)

• Pending the determination the application for medical

device registration, an establishment can continue their

business activities - import, export and placement in the

market (Section 80(3) of Act 737).

Updates and status

• The system, MeDCASt is in the FINAL stage;

• Fine-tuning the form to streamline with the Regulation;

• In-house testing is on-going;

• The guideline is in the pipe-line;

• TRIAL-RUN will take place in May;

• The launching of MeDCASt will be in June;

• The scheduled training will be held continuously

Idamazura IdrisPrincipal Assistant Director

Medical Device Registration Unit

Medical Device Authority

Email: idamazura@mdb.gov.my

FOR YOUR ATTENTION