MDA · MDR 2012 Third Schedule, Appendix 1 · MDA/GD/0007 and GD/0002
The MDA essential principles checklist, column by column.
Every Class B, C and D dossier carries an Essential Principles Conformity Checklist: one row per safety and performance principle, a Yes or a reasoned No, the standard or method used, and the document that proves it. Here is what the principles are, how MDA wants each column filled in, how IVDs differ, and what the CAB checks.
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Short answer
What the essential principles are.
The Essential Principles of Safety and Performance (EPSP) are the safety and performance requirements a medical device must meet to be registered in Malaysia. They are written into Appendix 1 of the Third Schedule, Medical Device Regulations 2012, and MDA explains them in MDA/GD/0007 for general devices and MDA/GD/0002 for IVDs. The manufacturer reviews the principles, selects those relevant to its device, documents why the others are excluded, and makes sure through design and manufacturing controls that the device meets them. MDA or the conformity assessment body then verifies that selection (MDA/GD/0007, section 5). The evidence is summarised in a table called the Essential Principles Conformity Checklist, which sits in the CSDT.
Where each piece is written down
| Document | What it gives you | Edition |
|---|---|---|
| MDR 2012, Third Schedule, Appendix 1 | The principles themselves, as law (paragraphs 2–19) | P.U. (A) 500/2012 |
| MDR 2012, Third Schedule, Appendix 2 and Table 1 | The duty to list the applicable principles in the CSDT, and the example checklist format | P.U. (A) 500/2012 |
| MDA/GD/0007 | The principles for general medical devices, numbered 6.1.1 to 6.2.11.2 | First Edition, March 2014 |
| MDA/GD/0002 | The principles for IVD medical devices, numbered 5.1 to 5.13 | First Edition, July 2013 |
| MDA/GD/0008, Appendix A | Example checklist and how to complete each column (general devices) | First Edition, March 2014 |
| MDA/GD/0004, Appendix A | The same for IVDs | First Edition, July 2013 |
| MDA/GD/0070, Annex 4 | What MeDC@St expects in the EPSP part of the CSDT for Class B, C and D, including the EU or Australian alternative and gap assessments for outdated standards | Second Edition, October 2025 |
The 6 general principles: they apply to every device
| MDA/GD/0007 | MDR 2012 App. 1 | What it requires |
|---|---|---|
| 6.1.1 | para 2 | Used as intended, the device does not compromise the clinical condition or safety of patients, users or others; any risks are acceptable when weighed against the benefits |
| 6.1.2 | para 3 | Design solutions follow safety principles and the state of the art. Risk is controlled in priority order: identify hazards, eliminate risk by inherently safe design, add protection measures (including alarms), then inform users of residual risk |
| 6.1.3 | para 4 | The device achieves the performance the manufacturer intends |
| 6.1.4 | para 5 | Safety and performance hold over the device’s stated lifetime under the normal stresses of use, when maintained as the manufacturer instructs |
| 6.1.5 | para 6 | Transport and storage conditions, such as swings in temperature and humidity, do not degrade the device |
| 6.1.6 | para 7 | The benefits outweigh any undesirable side effects |
MDA/GD/0007 says these six apply to all medical devices, so each needs a “Yes” and evidence. Clause 6.1.2 is where the risk management file does its work; the CSDT also has its own risk analysis element.
The design and manufacturing principles
MDA/GD/0007 has 11 groups. Whole groups or single clauses only apply to some devices; the last column shows which, using the guidance’s own wording.
| MDA/GD/0007 | MDR 2012 App. 1 | Covers | Clauses that depend on the device |
|---|---|---|---|
| 6.2.1 | para 8 | Chemical, physical and biological properties: materials, toxicity, flammability, biocompatibility, contaminants and residues, leaching, ingress and egress of substances | 6.2.1.3 (devices that administer medicinal products); 6.2.1.4 (a medicinal substance incorporated with an ancillary action) |
| 6.2.2 | para 9 | Infection and microbial contamination | 6.2.2.2–6.2.2.4 (substances, tissues or cells of biological, animal or human origin); 6.2.2.5–6.2.2.8 (sterile or special microbiological state); 6.2.2.9 (non-sterile packaging); 6.2.2.10 (same product sold sterile and non-sterile) |
| 6.2.3 | para 10 | Manufacturing and environmental properties: combinations with other devices, physical features, external influences such as electromagnetic effects, pressure and temperature, fire and explosion, waste disposal | 6.2.3.1 (used in combination); 6.2.3.2(e) (specimen identification); 6.2.3.2(g) (where maintenance or calibration is not possible, as with implants) |
| 6.2.4 | para 11 | Devices with a diagnostic or measuring function | The whole group; 6.2.4.3 only where calibrators or control materials are used |
| 6.2.5 | para 12 | Protection against radiation, intended and unintended | Devices that emit radiation; 6.2.5.5 for ionising radiation |
| 6.2.6 | paras 13 and 14 | Devices connected to or equipped with an energy source: programmable systems and software, power supply status and failure alarms, patient-monitoring alarms, electromagnetic emissions and immunity, electric shock | Powered devices and devices with software; the Regulations put electric shock in a separate paragraph 14 |
| 6.2.7 | para 15 | Mechanical risks: moving parts and instability, vibration, noise, energy-supply connectors, hot accessible surfaces | Depends on the design |
| 6.2.8 | para 16 | Risks from energy or substances supplied to the patient | Devices that deliver energy or substances to the patient |
| 6.2.9 | para 17 | Devices for self-testing or self-administration | Devices intended for lay persons in a non-clinical environment |
| 6.2.10 | para 18 | Information supplied by the manufacturer | Every device; the detail is in the Sixth Schedule (see labelling) |
| 6.2.11 | para 19 | Performance evaluation including, where appropriate, clinical evaluation | Every device for performance data; 6.2.11.2 where there are clinical investigations (Declaration of Helsinki) |
MDA/GD/0008 says the checklist is built from MDA/GD/0007’s list, yet its own example refers to “Essential Principle 9.2”, which is the Regulations’ numbering. We put both numbers in the first column so the CAB can trace a row either way.
How to fill in each column
| Column | What to write | Source |
|---|---|---|
| Device identification (header) | The device the checklist covers and, where applicable, each configuration or variant it covers | GD/0008 Note 5; MDR Table 1 note |
| Essential principle | Every principle from MDA/GD/0007 (or GD/0002 for IVDs). Rows that do not apply stay in, with a reason | GD/0008 Note 5; GD/0070 Annex 4 |
| Applicable to the device? | “Yes” or “No”. Every “No” is briefly explained | GD/0008 Note 5(a); GD/0070 Annex 4 |
| Method of conformity (the Regulations call it “rule of conformity”) | Title and reference of the standard, industry or in-house test method, comparison study or other method. For a standard, give its date and, where appropriate, the clause that shows conformity | GD/0008 Note 5(b); MDR Table 1 note (b) |
| Identity of specific documents | The certificates, test reports or study reports that resulted from the method, and where they sit in the technical documentation. For documents included in the submission, cross-reference their location in it | GD/0008 Note 5(c); GD/0070 Annex 4 |
MDA/GD/0070 lists the methods that may be used to show conformity:
- conformity with recognised or other standards;
- a commonly accepted industry test method;
- an in-house test method;
- evaluation of preclinical and clinical evidence;
- comparison with a similar device already on the market.
A recognised standard is one MDA deems to offer a presumption of conformity to specific essential principles (Third Schedule, Appendix 2 definitions; MDA/GD/0008). Where no recognised standard exists, the Regulations accept another means. Where a standard is the method, the CSDT carries the declaration of conformity to that standard and, if the standard sets no performance requirements, a summary of the test data (MDA/GD/0008).
A worked example
Illustrative rows for a sterile, single-use, non-powered device. The standards shown are common choices, not an MDA list; cite the edition you actually tested to.
| Principle | Applicable? | Method of conformity | Identity of specific documents |
|---|---|---|---|
| 6.1.2 / para 3: risk reduction | Yes | ISO 14971:2019, application of risk management to medical devices | Risk management report RM-01; CSDT, risk analysis |
| 6.2.1.1(b) / para 8: biocompatibility | Yes | ISO 10993-1 (edition tested to), with the endpoint tests it calls for | Biological evaluation report BE-02; CSDT, pre-clinical studies |
| 6.2.2.2 / para 9(2): substances of biological origin | No: the device does not incorporate substances of biological origin | – | – |
| 6.2.2.7 / para 9: validated sterilisation | Yes | ISO 11135:2014, ethylene oxide sterilisation | Sterilisation validation report SV-03; CSDT, pre-clinical studies |
| 6.2.5 / para 12: radiation | No: the device emits no radiation | – | – |
| 6.2.6 / paras 13–14: energy source | No: the device is non-powered and contains no software | – | – |
| 6.2.10.1 / para 18: information supplied | Yes | Sixth Schedule, MDR 2012; MDA/GD/0026; ISO 15223-1:2021 symbols | Label and IFU; CSDT, medical device labelling |
IVDs: MDA/GD/0002 instead of GD/0007
An IVD is assessed against MDA/GD/0002 (First Edition, July 2013), and its checklist follows Appendix A of MDA/GD/0004, with the same three columns. The six general principles (5.1.1–5.1.6) are the same. The rest differs:
- 5.2 Chemical, physical and biological properties: attention to incompatibility between materials and the specimen or analyte that could impair analytical performance, and special attention to leachables that are carcinogenic, mutagenic or toxic to reproduction.
- 5.4 Materials of biological origin: animal, human and microbial material. Viral inactivation may not apply where the agent is integral to the device’s purpose, and the manufacturer must keep the geographical origin of the animals.
- 5.5 Manufacturing and environmental properties: adds use error from ergonomics and human factors, software interacting with its environment, and carry-over between IVDs.
- 5.6 Performance characteristics: sensitivity, specificity, trueness, precision (repeatability and reproducibility), interference and limits of detection, maintained over the device’s lifetime. Calibrator and control values must be traceable to reference measurement procedures or higher-order reference materials.
- 5.8 Software and standalone IVD software: validated to the state of the art, taking account of the development life cycle, risk management, verification and validation.
- 5.11 Self-testing devices are designed around lay persons, and 5.13 Performance evaluation reviews analytical and, where appropriate, clinical performance data from literature, performance study reports and experience from routine diagnostic testing.
How the CAB and MDA review it
- The selection is checked. Under MDA/GD/0007, section 5, MDA and/or the CAB verify which principles the manufacturer selected and its reasons for excluding the rest during conformity assessment.
- Class C and D. Paragraph 8 of the Third Schedule requires the manufacturer to submit the CSDT and the CAB to review it to verify conformity.
- Class B, C and D in MeDC@St. MDA/GD/0070, Annex 4 lists the EP checklist under the CSDT section: the Malaysian checklist, or an EU or Australian Essential Requirements checklist that addresses similar elements. Each row needs the method, its reference and the controlled document, with a rationale for every principle that does not apply.
- Supporting documents. Anything the CSDT references must be legible, within its validity period, submitted in full, and signed off and dated by whoever issued it (Appendix 2 of the Third Schedule; MDA/GD/0070).
- Class A. The MeDC@St form has no CSDT section, but Section 10 is the Declaration of Conformity, in which the manufacturer attests compliance with all essential principles. See Class A registration.
- Verification route. A device approved by a recognised regulator, such as under the HSA verification route, still goes through the CAB with an EP checklist. MDA/GD/0070 names the EU and Australian checklists as alternatives and no others, so we map an HSA file to the Malaysian principles.
How the checklist fits with the rest of the file
| Item | How it relates to the checklist |
|---|---|
| Classification | The class sets how deep the CSDT goes (Appendix 2) and whether CAB review of it is mandatory (paragraph 8) |
| CSDT | The checklist is the CSDT element “relevant essential principles and rule used to demonstrate conformity”; the rest of the CSDT holds the evidence it points to |
| Declaration of Conformity | The signed attestation that the device complies with all applicable essential principles; the checklist is the itemised proof behind it |
| CAB | Verifies the selection of principles and the evidence for Class B, C and D |
| AMDD | Annex 1 of the ASEAN directive sets the regional essential principles; Malaysia’s version is Appendix 1 of the Third Schedule |
Points the guidance is specific about
- A “No” must carry a reason (MDA/GD/0008 Note 5(a); MDA/GD/0070).
- A standard is listed with its date and, where appropriate, the clause (MDA/GD/0008 Note 5(b)).
- An outdated standard needs a gap assessment to the state of the art (MDA/GD/0070).
- Every cited document is complete, valid, signed and dated (Appendix 2 of the Third Schedule; MDA/GD/0070).
- The checklist names the device and the configurations it covers (MDA/GD/0008 Note 5).
- The brand name is the same on the label, the DoC and the technical documentation (MDA/GD/0070).
Jawapan ringkas · Bahasa Malaysia
Apakah senarai semak Essential Principles (EPSP) untuk pendaftaran peranti perubatan MDA?
Senarai semak pematuhan Essential Principles of Safety and Performance (EPSP) ialah jadual dalam CSDT yang menyenaraikan setiap prinsip dalam Lampiran 1, Jadual Ketiga, Peraturan-Peraturan Peranti Perubatan 2012 dan MDA/GD/0007 (MDA/GD/0002 bagi peranti IVD). Bagi setiap prinsip, nyatakan sama ada ia terpakai (Ya atau Tidak, dengan sebab jika Tidak), kaedah pematuhan seperti standard berserta tarikh dan klausa, dan rujukan dokumen bukti dalam dokumentasi teknikal. Enam prinsip umum terpakai kepada semua peranti. WhatsApp 010-206 2070.
FAQ
Frequently asked questions
What is the essential principles checklist for MDA registration?
The Essential Principles Conformity Checklist is a table in the CSDT that lists every Essential Principle of Safety and Performance, says whether each applies to the device, names the standard or other method used to show conformity, and points to the document that proves it. The principles are set out in Appendix 1 of the Third Schedule of the Medical Device Regulations 2012 and explained in MDA/GD/0007 (general devices, First Edition, March 2014) and MDA/GD/0002 (IVDs, First Edition, July 2013). The recommended format is Table 1 of the Third Schedule and Appendix A of MDA/GD/0008.
How many essential principles are there?
MDA/GD/0007 groups them into 6 general principles that apply to every medical device and 11 design and manufacturing principles, some of which apply to a given device. The Regulations set out the same requirements as paragraphs 2 to 19 of Appendix 1. There, protection against electrical risks is its own paragraph (14), so the design and manufacturing part has 12 headings. IVDs follow MDA/GD/0002, which has 13 sections, including separate ones for performance characteristics and IVD software.
Can we answer “No” for a principle that does not apply?
Yes, but every “No” needs a short explanation. MDA’s own example is a device without biological substances: “No – The medical device does not incorporate biological substances.” MDA/GD/0070 asks for a documented rationale for each principle that does not apply. Under MDA/GD/0007, the CAB or MDA verifies which principles the manufacturer selected during conformity assessment.
Can we submit our EU or Australian checklist instead?
For Class B, C and D, MDA/GD/0070 (Second Edition, October 2025) allows the checklist of EU or Australian Essential Requirements in place of the Malaysian EP checklist, provided it addresses similar elements. It must still give the method, the reference and the controlled document for each requirement, and a rationale for each one that does not apply. The guide names no other regulator’s checklist, such as Singapore’s.
What if the standards we cite are out of date?
MDA/GD/0070 says that if outdated standards were applied, a gap assessment must be provided to demonstrate the state of the art. Each standard in the checklist should be listed with its full title, number and date and, where appropriate, the clause that shows conformity (MDA/GD/0008).
Does a Class A device need an essential principles checklist?
The checklist is not uploaded for Class A: MDA’s Class A form in MeDC@St (MDA/GD/0070, Annex 3) has no CSDT section. The manufacturer still attests in the Declaration of Conformity, Section 10 of that form, that the device complies fully with all essential principles. We keep a completed checklist on file for Class A devices so that the attestation is backed by evidence.
Who prepares the checklist, the manufacturer or the authorised representative?
The manufacturer. Paragraph 8 of the Third Schedule requires the manufacturer to collect and examine the evidence of conformity to the essential principles and compile it in technical documentation. For an imported device, paragraph 10 makes the authorised representative obtain that evidence from the foreign manufacturer and appoint a registered CAB. As the AR, we check the checklist against Malaysian requirements before it goes to the CAB.
Need a checklist that survives CAB review?
Send us the device description, the test reports and the standards you test to. We will build the essential principles checklist against MDA/GD/0007 (or GD/0002 for IVDs), justify every “No”, flag outdated standards that need a gap assessment, and cross-reference each row to the CSDT before it goes to the CAB.