MDA registration documents: the full checklist, by class and route.
What you need depends on the device class and on whether a recognised regulator has already approved it. This is the list MDA and the conformity assessment bodies work from, with who supplies each document.
Short answer: every MDA application needs the device’s classification and grouping, the manufacturer’s quality management system certificate, labels and instructions for use, post-market history and a signed Declaration of Conformity. Class B, C and D also need a full CSDT dossier and a report and certificate from a conformity assessment body (CAB). Class A needs neither. A foreign manufacturer must also authorise its Malaysian authorised representative.
The checklist by class
| Document | Comes from | Class A | Class B, C, D |
|---|---|---|---|
| Class and classification rule (how to classify) | Manufacturer or AR | Yes | Yes |
| Device list and grouping, with identifiers (grouping rules) | Manufacturer | Yes | Yes |
| Device information: name, brand, description, intended use and HS, GMDN and UDI codes | Manufacturer | Yes | Yes |
| Establishment licence as manufacturer or authorised representative (licence guide) | Applicant in Malaysia | Yes | Yes |
| Authorisation of the AR, normally a letter of authorisation with the device list (AR service) | Foreign manufacturer | Imported devices | Imported devices |
| QMS certificate covering the device, with manufacturing sites | Manufacturer | Yes | Yes |
| Labels and instructions for use (labelling rules) | Manufacturer, with AR details added | Yes | Yes, in the CSDT |
| CSDT dossier (section by section) | Manufacturer, compiled with the AR | No | Yes |
| CAB report and certificate | Conformity assessment body | No (Exemption Order 2024, para 5) | Yes |
| Foreign approval certificate (verification route) | Manufacturer | Optional, but advisable | Verification route only |
| Post-market history: adverse events, field corrective actions and recalls, or an attestation of none | Manufacturer | Past 3 to 5 years | Past 3 years on the verification route |
| Declaration of Conformity (what it must say) | Manufacturer | Yes, signed | Yes, Appendix 3 format, signed by top management |
Sources: MDA’s Class A submission guide, MDA/GD/0070 Annex 4 and the Third Schedule of the Medical Device Regulations 2012. MDA and the CAB may ask for additional documents.
Inside the CSDT for Class B, C and D
MDA/GD/0008 sets eight elements. IVDs use MDA/GD/0004 instead, which also asks you to state the intended users, such as lay people or trained staff.
- Executive summary: intended use, marketing history, approvals from reference agencies, and reportable adverse events and field corrective actions.
- Essential principles checklist: each principle and the standard or method used to meet it.
- Device description: how it works, materials, accessories, class and rule, and every configuration to be registered.
- Design verification and validation: pre-clinical studies such as biocompatibility, electrical safety and sterilisation, and software validation.
- Clinical evidence: a clinical evaluation report.
- Labelling: labels, packaging, instructions for use, and promotional material.
- Risk analysis: a risk management report, to ISO 14971 on the verification route.
- Manufacturer information: manufacturing process, environment and controls, and the sterilisation method where relevant.
Extra evidence for particular devices
| If the device is | Add |
|---|---|
| Supplied sterile | Sterilisation validation (bioburden, pyrogen, sterilant residues where relevant, packaging validation), evidence of revalidation and a post-sterilisation functional test |
| Measuring, where inaccuracy could significantly harm the patient | Studies showing conformity with metrological requirements |
| Active (powered) | Electrical safety and EMC evidence, typically to the IEC 60601-1 series |
| Made with materials of biological origin | Biological-material safety evidence |
| An IVD | The IVD CSDT under MDA/GD/0004 and IVD grouping under MDA/GD/0054 (IVD registration) |
| An HIV self-test | MDA/GD/0065 Table 1, including a layman usability report and a self-test versus professional test report (self-test kits) |
Rules every document must meet
- In English or Bahasa Malaysia.
- Complete and legible, signed and dated by its issuer, and within its validity period.
- Submitted in full as an annex if the CSDT refers to it.
- The same dossier the CAB reviewed goes into MeDC@St.
- Intended use consistent with the use approved abroad, on the verification route.
- For EU and TGA approvals, the manufacturer’s declaration of conformity goes in beside the certificate.
Where document sets usually fall short
- A configuration list whose model numbers do not match the labels and certificates.
- Marketing history or the adverse-event summary left out of the executive summary.
- Standards cited without their full title, number and date, or principles marked not applicable with no reason.
- Declarations of conformity to standards with no test reports behind them.
- A clinical evaluation report that does not cover the current models.
- A QMS certificate that has lapsed, or whose scope does not cover the device.
Re-registration: the shorter list
Re-registration opens one year before the 5-year certificate expires, and after expiry a new application is needed. All classes need an updated QMS certificate, label, post-market data and Declaration of Conformity. Class B, C and D also need an updated clinical evaluation or performance report, risk analysis and CAB report and certificate, plus change notification letters or a no-change declaration covering the last 5 years. See our re-registration guide.
After you submit
MDA reviews a Class B, C or D application in 30 working days once the documents are complete and payment has cleared. Each query is answered in writing in MeDC@St. Information MDA requests must arrive within 90 working days, or the application is rejected and the fee is not refunded (MDA/GD/0070). The whole sequence is in how to register a medical device and our registration timeline.
Our all-in fee per device is RM3,800 for Class A, RM6,800 for Class B, RM9,800 for Class C and RM12,000 for Class D, including the dossier and the CAB and MDA fees. See pricing.
Apakah dokumen yang diperlukan untuk pendaftaran peranti perubatan dengan MDA?
Setiap permohonan memerlukan klasifikasi dan pengumpulan peranti, sijil sistem pengurusan kualiti pengilang, label dan arahan penggunaan, sejarah pasca pasaran dan Perisytiharan Pematuhan yang ditandatangani. Kelas B, C dan D juga memerlukan dokumen CSDT serta laporan dan sijil daripada badan penilaian pematuhan (CAB). Peranti import memerlukan surat kebenaran daripada pengilang asing kepada wakil sah di Malaysia. Dokumen hendaklah dalam Bahasa Inggeris atau Bahasa Malaysia. WhatsApp 010-206 2070.
Frequently asked questions
What documents are needed to register a medical device in Malaysia?
Does a Class A device need a CSDT?
Is ISO 13485 mandatory for MDA registration?
Does a CE or FDA approval replace these documents?
What language must the documents be in?
Who prepares the documents, the manufacturer or the authorised representative?
What documents are needed for re-registration?
How long do we have to answer MDA’s questions?
Holding a folder of manufacturer documents?
Send it to us. We map it against MDA's list, ask the manufacturer for what is missing and build the dossier as part of the registration.