How to Register an IVD in Malaysia: A Step-by-Step Guide

Registering an in vitro diagnostic (IVD) device in Malaysia involves more steps than many manufacturers expect. Every submission must go through a licensed Local Authorised Representative (LAR) who holds an active MeDC@St account. Class B, C, and D IVDs must also pass CAB conformity assessment before MDA will formally accept the application, and the technical documentation required for IVDs differs from the standard medical device pathway in several important ways.

This guide walks through every stage of the IVD registration process in Malaysia in the order you will encounter them, from confirming your device's classification through to receiving your registration certificate. It is written for manufacturers preparing their first Malaysian IVD registration and for those who have encountered delays and want to understand where the process typically breaks down.

Prior to Submitting: What Must Be Done First

There are a number of factors that need to be confirmed or done prior to preparing the first page of the MDA submission. The main mistake that causes delay in this process is trying to skip this step since the submission will not pass the administrative completeness check and will not be reviewed.

1. Establish Classification of IVD

   Based on the seven IVD classification rules in MDA/GD/0001, classify your product as A, B, C or D. Classification determines the registration route, conformity assessment, and registration fee. When several rules apply to your device, then you must take the highest of all applicable rules into consideration. It is recommended to keep the record of your rationale behind the IVD classification, which MDA and CAB can ask you for during the review process.

   Some of the key factors for IVD classification are self-testing by layperson (Rule 3, Class C), if the product is a companion diagnostic (Rule 4, Class D), if the product is general laboratory instrument (Rule 5, Class A), and if it includes reagents for blood grouping or tests dangerous life threatening infectious diseases (Rules 1 & 2, Class C/D).

2. Appoint a Licensed Local Authorised Representative (LAR)

   A foreign manufacturer must appoint a Malaysian entity that holds a valid MDA Establishment Licence and a Good Distribution Practice for Medical Devices (GDPMD) certificate to act as LAR. The LAR holds the MeDC@St account, submits all applications on the manufacturer's behalf, and is legally responsible for the device's compliance in Malaysia. All registration certificates are issued in the LAR's name.

   The appointment must be formalised through a written agreement before any submission is made. See our full guides on what a LAR is and how to appoint one for the complete process.

3. Prepare the IVD CSDT Technical Dossier

   The Common Submission Dossier Template for IVDs (MDA/GD/0004) is the required format for the technical documentation submitted to MDA. It follows the same general structure as the standard CSDT but requires a performance evaluation report in place of a clinical evaluation report, and references the IVD-specific Essential Principles document (MDA/GD/0002) rather than the general EPSP.

   The IVD CSDT must be substantially complete before submission. MDA will not accept a partial dossier into formal review. Preparing the dossier to a standard that will pass CAB and MDA scrutiny typically takes several months, particularly if performance evaluation studies need to be commissioned or consolidated from multiple sources.

4. Complete CAB Conformity Assessment (Class B, C, D Only)

   Class B, C, and D IVDs must be assessed by an MDA-approved Conformity Assessment Body (CAB) before MDA will accept the registration application. The CAB reviews the IVD CSDT against the Essential Principles and issues a Conformity Assessment Certificate (CAC) on successful completion. Class A IVDs are exempt and submit directly to MDA.

   The CAB assessment route available depends on whether the device holds a prior approval from a reference regulatory authority (FDA, CE, HSA, PMDA, TGA, or Thai FDA as of 2026). Full assessment involves a comprehensive review of all technical documentation. The verification route is available for devices with a recognised reference approval and is typically faster, but still requires a complete technical dossier. Full CAB assessment typically takes three to six months for a well-prepared submission; deficiency rounds can extend this significantly.

How to Submit an IVD Registration via MeDC@St

All IVD registration applications in Malaysia are submitted through MeDC@St, the MDA's online medical device registration portal. The LAR manages the account and is the only party who can initiate and manage submissions. The portal handles the full application lifecycle: submission, fee payment, query responses, and certificate download.

1. Login to MeDC@St as LAR

   LAR logs into MeDC@St using the login credentials used during registration. Only those organizations having a valid MDA Establishment Licence and GDPMD certificate are eligible to have a MeDC@St account. In case the LAR does not have an up-to-date MDA Licence and GDPMD certificate, no new application would be possible. Ensure that these are valid before initiating any application.

2. Create a new IVD registration application

   While creating a new IVD application, choose "IVD Medical Device" as the device type. This would populate the relevant fields for an IVD instead of the general medical device application. Enter the details of the device such as name of the device, purpose of use, device class, IVD category (chemistry, microbiology, immunology, haematology, clinical toxicology, pathology, or others), GMDN code, manufacturer details and country of manufacture.

   Device name and purpose of use entered in MeDC@St should match that of the device label, IFU and technical dossier. Any discrepancies in these are often one of the major reasons for administrative clarifications required during acceptance check.

3. Upload the Required Documents

   Upload the complete application package to MeDC@St. All documents must be in PDF format. File naming should be clear and consistent with the dossier index. The mandatory documents for each class are set out in the documentation table below. For Class B, C, and D IVDs, the CAB Conformity Assessment Certificate must be current and valid at the time of MDA submission.

4. Pay the Registration Fee

   Registration fees are paid through MeDC@St at the time of submission. Fees are set under the Medical Device (Fees) Regulations and vary by device class. The table below sets out the current registration fees by class. Keep records of all fee receipts as they establish the date of submission and may be needed to resolve any administrative disputes about the start of MDA's review clock.

   Device Class	Registration Fee (RM)	Notes
   Class A	RM 500	Increased from previous rate effective 2026. Submits directly to MDA with no CAB fee.
   Class B	RM 1,500	CAB conformity assessment fee is separate and charged by the CAB directly.
   Class C	RM 3,000	CAB conformity assessment fee is separate and charged by the CAB directly.
   Class D	RM 5,000	CAB conformity assessment fee is separate and charged by the CAB directly.

5. MDA Administrative Completion Check

   The MDA carries out administrative completion check before processing the application to substantiate review. Should there be any deficiencies in documents or inconsistencies and/or improper formatting of documentation, MDA will issue you with deficiency letter, and your application will be reviewed after the deficiencies are corrected. The 180-day review clock starts counting time only upon acceptance of the application by the MDA. Your application may stay pending at the administrative completion check stage for several weeks due to deficiencies raised, and that is why document consistency before submission is crucial.

6. Answer MDA Technical Queries

   During substantive review, MDA may raise questions through MeDC@St. The LAR receives notifications of such queries via the portal and email. The responses must be given within the time frame specified in the queries, normally 30 to 60 days. Monitoring of MeDC@St regularly is essential during review period since failure to respond to queries may result in delay of review process and even rejection of the application.

   Your answers to queries must cover all the issues. In case MDA requests for revisions of the labeling and additional performance data, make sure they remain consistent with the initial dossier.

7. Receive the Registration Certificate

   On approval, the MDA issues a registration certificate for the device, which is downloadable from MeDC@St. The certificate lists the device name, registration number (MDA/XXXXXX/XXXX), the LAR, the manufacturer, and the registration expiry date. Registration is valid for five years from the date of issue. The device is simultaneously listed in the Malaysia Medical Device Register (MMDR), which is publicly searchable.

   Set a calendar reminder to initiate renewal well before the expiry date. A registration that lapses requires a fresh full registration application rather than a renewal, which significantly increases both the timeline and cost of returning the device to the Malaysian market.

IVD Registration: Documentation Requirements by Class

The documentation requirements for IVD registration are largely consistent across classes, with the key difference being that Class B, C, and D submissions are reviewed by a CAB before MDA, and the depth of documentation expected increases with device class. The table below sets out the core documents required and their applicability by class.

Timeline for IVD Registration in Malaysia

The target time for MDA review is 180 days from acceptance, but the entire process takes considerably longer than that, beginning from preparation up to receiving the certificate. The processes that take the most time are the preparation of technical dossier and CAB conformity assessment, which depend on the quality of the dossier.

Common Mistakes That Delay IVD Registration

1. Submitting a performance evaluation report that does not meet IVD standards

   The most frequently flagged deficiency. A clinical evaluation report structured for a general medical device, based on literature review of clinical outcomes, does not satisfy IVD requirements. The performance evaluation must cover precision, accuracy, linearity, analytical sensitivity and specificity, and for clinical IVDs, diagnostic sensitivity and specificity from a properly conducted study.

   For self-testing devices, a lay user study is additionally required to demonstrate that untrained users can achieve accurate results following the IFU without assistance. Identifying this gap before CAB submission rather than during it avoids significant delays.

2. Missing or inadequate Bahasa Malaysia IFU for self-testing devices

   Self-testing IVDs require an IFU in Bahasa Malaysia. Submitting English-only labelling is a standard deficiency that triggers delays at both CAB and MDA stages. The BM IFU must be a complete translation at a reading level appropriate for lay users, not a summary or a partial adaptation.

3. ISO 13485 certificate scope does not match the device being registered

   A certificate scoped to "IVD instruments" does not automatically cover test strip or reagent manufacture. MDA and CABs check that the scope explicitly covers the product type. Where the scope is ambiguous, contact the certification body for a scope confirmation letter before submission.

4. Inconsistencies between documents submitted in MeDC@St

   Device name, intended use, manufacturer details, and model identifiers must be identical across the application form, DoC, labelling, and CSDT. Any inconsistency triggers an administrative deficiency and delays the start of the 180-day review clock. A pre-submission cross-check of all documents against a single reference list of device details eliminates most of these deficiencies before they are raised.

5. CAB certificate lapses between assessment and MDA submission

   CAB certificates have a defined validity period. If the MDA submission is delayed after CAB assessment, for example while other components of a multi-device submission are being finalised, the CAB certificate may expire before MDA acceptance. Confirm the CAB certificate validity period and plan the MDA submission timeline to ensure the certificate remains current at the point of submission.

Variation Applications After Registration

Once a device is registered, any change to the approved information must be notified to MDA through a variation application filed via MeDC@St. Proceeding with a change without filing a variation is a compliance violation. Understanding which changes require a variation and which are administrative updates prevents manufacturers from inadvertently breaching the terms of their registration.

Changes that require a variation application include: amendments to the device name or brand, changes to the intended use or indications, adding or removing device models covered under the registration, changes to the manufacturer name or manufacturing site, changes to the labelling or IFU that affect safety information, and changes to the technical specifications or materials that affect performance or safety. Changes to the LAR require a separate LAR change application rather than a standard variation.

Variation applications are submitted and managed through MeDC@St in the same way as the original registration. The review timeline for a variation depends on the type and significance of the change. Major variations that affect safety or performance are reviewed substantively and may require updated technical documentation. Minor variations are typically processed more quickly.

Post-Registration Obligations for IVD Manufacturers

Receiving the registration certificate is not the end of the compliance journey. Manufacturers and their LARs carry ongoing obligations throughout the life of the registration. Failure to meet these obligations can result in suspension or cancellation of the registration.

1. ePermit for Every Import and Export Shipment

   From 2 January 2026, an ePermit is mandatory for every import or export shipment of a registered medical device, including IVDs. The ePermit application is submitted through the MeDC@St portal by the LAR before each shipment. Operating without a valid ePermit for a shipment is a violation under the Medical Device Act 2012, regardless of whether the device itself holds a valid registration certificate.

2. Adverse Event Reporting

   The LAR is responsible for reporting serious adverse events and field safety corrective actions (FSCAs) involving the registered IVD to MDA within the timeframes set under the Medical Device Regulations. Serious adverse events that result in death or serious deterioration of health must be reported within 30 days. Immediate threats to public health must be reported within two days. Adverse event reports are submitted through MeDC@St.

3. Post-Market Surveillance

   Manufacturers are required to maintain an active post-market surveillance system for registered IVDs. This includes systematic collection and review of performance data from the field, complaint handling, and periodic safety update reports for higher-risk devices. Post-market surveillance records must be available for MDA inspection. For Class C and D IVDs, a post-market performance follow-up plan is expected as part of the ongoing technical file.

4. Registration Renewal

   IVD registration certificates are valid for five years. A renewal application must be submitted through MeDC@St before the expiry date to maintain continuous market authorisation. MDA does not issue automatic reminders. If the certificate lapses, the device must go through a full new registration rather than a renewal, which resets the entire timeline and cost. Set calendar reminders at 12 months and six months before each expiry date.

Frequently Asked Questions