The MDA Declaration of Conformity, field by field.
Every MDA registration, Class A to D, carries a Declaration of Conformity signed by the manufacturer. Here is what the Regulations require it to say, what the device particulars and QMS blocks must contain, who may sign it, and how the CAB and MDA review it.
What the DoC is.
The Declaration of Conformity (DoC) is the manufacturer’s written attestation that the device conforms to all applicable Essential Principles of Safety and Performance, has been classified under the First Schedule rules, has met all applicable conformity assessment elements, and complies with Act 737 and its regulations. The format is fixed in Appendix 3 of the Third Schedule, Medical Device Regulations 2012, and MDA explains it in MDA/GD/0025 (First Edition, February 2016, still the current edition). The manufacturer must also hold documents sufficient to support it.
What the DoC must contain
| Element | What to write | Source |
|---|---|---|
| Manufacturer | Name and address of the manufacturer, on the manufacturer’s letterhead | App. 3 para 2(g); GD/0025 s.6(a) |
| Attestations | Each device covered (i) complies with the applicable essential principles in Appendix 1 of the Third Schedule, (ii) is classified under the First Schedule rules, (iii) has met all applicable conformity assessment elements | App. 3 para 2(a); GD/0025 s.6(b) |
| Device particulars | Enough to identify every device the DoC covers (see the next table) | App. 3 para 2(b)–(d); GD/0025 Table 1 |
| Conformity assessment | Statement that the Third Schedule conformity assessment elements have been applied | App. 3 para 2(e); GD/0025 s.6(d) |
| QMS certificate | Issuing body, certificate number, issue and expiry dates | App. 1A part (B) |
| Standards applied | Every standard applicable to the individual device | App. 1A part (C); GD/0025 s.6(f) |
| Valid-from date | Day, month and year from which the declaration is valid | App. 3 para 2(f); GD/0025 s.6(e) |
| Section 76 attestation | Acknowledgement that making, signing or furnishing an untrue, inaccurate or misleading declaration is an offence, worded as in the MeDC@St template | GD/0025 s.6(g) |
| Signatory | Name, position and signature of the authorised person, and the date | App. 3 para 2(h); GD/0025 s.6(h), s.7 |
The template itself is Appendix 1A of the Third Schedule, which MDA/GD/0025 reproduces as Annex A and MeDC@St offers as a form. Using it is optional; the contents above are not. The note under the Regulations’ template also asks for the DoC and its supporting documents, certificates and attestations to be certified true copies by the applicant.
Device particulars (MDA/GD/0025, Table 1)
| Field | What MDA means by it |
|---|---|
| Generic name | The name that identifies the device irrespective of trademark |
| Specified name | The manufacturer’s name for the device, distinct from other manufacturers’ devices |
| Brand / model | The name, term, design, symbol or other identifier the manufacturer gives the device |
| Manufacturer | The manufacturer who owns the brand |
| Country of origin | The manufacturer’s country |
| Manufacturing site | Name and address of the site |
| Risk-based classification | Class A, B, C or D under Appendix 1 (general) or Appendix 2 (IVD) of the First Schedule |
| Classification rule | Rule 1–16 for general devices, Rule 1–7 for IVDs |
| GMDN code | Preferably, where available |
| Registration number or approval code | The number or pre-market approval code issued by a GHTF founding-member authority |
The attestation is made for each device subject to the declaration, so if one application covers a family, system or set under the grouping rules, the particulars need to identify every device in it. Work out the class and rule first; our classification guide walks through the First Schedule.
The QMS block by class
- Class B, C and D: declaring conformity to MS ISO 13485 or another QMS standard recognised by MDA is mandatory.
- Class A not made under those standards: list any certification to an alternative QMS standard, if there is one.
- Class A with a measuring function: the conformity assessment certificate and the calibration and metrology report, with issue and expiry dates.
- Class A supplied sterile: the sterilisation validation report and the conformity assessment certificate number, with issue and expiry dates.
MDA/GD/0070 adds that the QMS information must be valid and that both vertical and horizontal standards are stated, so check the expiry date of the QMS certificate the DoC quotes before you submit.
Who signs it
| Manufacturer | Signatory under MDA/GD/0025 |
|---|---|
| Local manufacturer | Top management, or the person responsible with a letter of authorisation signed by top management |
| Foreign manufacturer | Any person in the foreign manufacturer’s top management |
MDA counts the proprietor, president, vice president, director, CEO, managing director or general manager as top management, depending on the organisation. MDA/GD/0070 (2025) says simply that the DoC is signed by the company’s top management, so a top-management signature satisfies both documents. For an imported device the authorised representative does not sign it: under paragraph 10 of the Third Schedule the AR obtains the evidence of conformity from the foreign manufacturer and appoints a registered CAB.
How the DoC fits with the essential principles, the CSDT and the CAB
The Third Schedule lists four conformity assessment elements: the quality management system, the post-market surveillance system, the technical documentation and the Declaration of Conformity. The DoC is the signed summary; the evidence sits in the technical documentation, compiled in the CSDT format.
- Essential principles. MDA/GD/0007 sets out 6 general principles that apply to every device and 11 design and manufacturing principles, some of which apply to each device. The manufacturer selects the relevant ones and documents why the others are excluded, and MDA or the CAB verifies that choice. IVDs have their own guidance, MDA/GD/0002.
- Class B, C and D. The conformity assessment body reviews and confirms the adequacy of the DoC against the supporting evidence and may ask for more. The CAB-reviewed DoC is uploaded to MeDC@St.
- Class A. There is no CAB stage. The DoC goes to MDA directly as Section 10 of the MeDC@St form; see Class A registration.
- Verification route. Where an EU or TGA approval is relied on, the manufacturer’s declaration of conformity is submitted with the EC certificate or TGA licence, and a DoC in the Appendix 3 format is still required in its own section.
Points the guidance is specific about
- The brand name must appear on the label, the DoC and the technical documentation (MDA/GD/0070 and MDA’s Class A guide), so the three must match.
- The standards are listed for the individual device, not as a company-wide list.
- The DoC states the date from which it is valid.
- At re-registration an updated DoC is required, with valid QMS details.
- A local manufacturer’s person responsible signs only with a top-management letter of authorisation attached.
Section 76: a false declaration is an offence
Under section 76(1) of Act 737, anyone who makes, signs or furnishes a declaration, certificate or other document required under the Act that is untrue, inaccurate or misleading in any particular commits an offence, punishable on conviction by a fine of up to RM100,000, up to two years’ imprisonment, or both. The DoC template makes the signatory acknowledge this, which is why it is signed by someone with authority over the evidence behind it.
Apakah kandungan Deklarasi Pematuhan (Declaration of Conformity) untuk pendaftaran MDA?
Deklarasi Pematuhan ditetapkan dalam Lampiran 3, Jadual Ketiga, Peraturan-Peraturan Peranti Perubatan 2012 dan MDA/GD/0025. Ia mesti mengandungi nama dan alamat pengilang, pengakuan bahawa peranti mematuhi prinsip keselamatan dan prestasi yang berkaitan, telah dikelaskan mengikut Jadual Pertama dan telah melalui elemen penilaian pematuhan, butiran peranti, sijil QMS, senarai standard, tarikh berkuat kuasa, pengakuan seksyen 76 Akta 737, serta nama, jawatan dan tandatangan pengurusan atasan pengilang. WhatsApp 010-206 2070.
Frequently asked questions
What is a Declaration of Conformity for MDA registration?
Is there an official MDA Declaration of Conformity template?
Who signs the Declaration of Conformity?
Does a Class A device need a Declaration of Conformity?
Can our authorised representative sign the DoC for the foreign manufacturer?
Is our EU Declaration of Conformity enough?
Do we need a new DoC for re-registration?
Need the DoC to match the dossier?
Send us the device list, the QMS certificate and the standards you test to. We will draft the Declaration of Conformity in the Appendix 3 format, check it against the label and CSDT, and get it signed by the right person before the CAB sees it.