REGISTRATION OF MEDICAL DEVICE SUBMISSION & APPLICATION By IDAMAZURA IDRIS MEDICAL DEVICE AUTHORITY
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) Introduction
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 - Requirements
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)] Application of Medical Device Registration - Procedures
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. Reference documents
Class D 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 B CSDT and its supporting documents and DoC C Class A, B A Class C R I S K Comprehensiveness of the information required Document to be submitted Class D CSDT and its supporting documents and DoC Documentation for medical device registration
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. The Registration Form
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 General Information
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 Grouping of medical device
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 CSDT and its supporting documents
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 Elements 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 Preparation of CSDT
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. Details of importer/distributor
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 Post-market vigilance history
Information on the usage; whether the device is for Single use Professional use Home use Information on the requirements of installation and maintenance; Information on usage, installation and maintenance
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 conformity
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 Declaration of Application
The application of medical device registration The flow Start End Go to MDA web page Submit the application Create an account Make application declaration Validate the email address provided Successful? Yes No Upload the DoC Log in to the system Upload the supporting documents Choose Medical Device Registration Module Complete the form
Account creation
No Request for application fee Yes Satisfy? Paid? Yes No Return the application to the applicant for further information Notify the receipt of payment Evaluate the application and verify the documents Verify the class & group of medical device No Receive application & notify the receipt of application Start Satisfy? *The application will be dropped from the system Yes Request for registration fee No Paid? Yes End The registration of Notify the receipt of payment and register the medical medical device device The flow *If the payment is not received within the specified time (30 working days)
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 Return of the application
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) The registration 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. Changes of medical device
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). Transition
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 Updates and status
FOR YOUR ATTENTION Idamazura Idris Principal Assistant Director Medical Device Registration Unit Medical Device Authority Email: idamazura@mdb.gov.my