registration of medical device - crest evendz...the registration form • one of the medcast modules...
TRANSCRIPT
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: [email protected]
FOR YOUR ATTENTION