MDA Opens Public Comment: New “Definitions of Medical Devices” Guidance

On 4 December 2025, the Medical Device Authority (MDA) of Malaysia published a draft guidance document titled “Definitions of Medical Devices” and opened a public comment period from 4 to 18 December 2025.

This draft guidance aims to clarify the classification of medical devices, including what constitutes a “device,” as well as definitions for accessories, components and spare parts areas that have often caused uncertainty in regulatory submissions.

This is a significant regulatory development, and we believe it warrants attention from manufacturers, authorised representatives (ARs), distributors, and all stakeholders in Malaysia’s medtech ecosystem.

What the Draft Guidance Covers

• Clear definitions: The draft sets out clear criteria to distinguish “medical devices” from accessories, components, or spare parts. This clarity helps avoid misclassification and ensures proper regulatory treatment.

• Examples included: To illustrate the definitions, MDA provides examples of what qualifies as accessories, components, and spare parts useful for companies assessing their product portfolios.

• Legal alignment: The guidance will operate alongside existing legislation: the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012.

• Opportunity for stakeholder feedback: Until 18 December 2025, stakeholders can submit feedback using the form provided by MDA. This makes it a critical period for those who wish to raise concerns or suggest improvements.

  
  

Why This Matters for the Industry

• Reduces regulatory ambiguity

  
  

  Clear definitions reduce grey areas, especially for products that may straddle lines (device vs accessory vs spare part). This helps ensure accurate classification and compliance.

• Minimises risk of incorrect classification

  
  

  Misclassifying a product can lead to compliance issues, registration delays, or even rejection. This guidance helps avoid such risks by setting standardised definitions.

• Supports smoother product lifecycle management

  
  

  By clarifying components vs devices, manufacturers and authorised representatives can better manage submissions, changes, maintenance, labelling, and post-market obligations.

• Encourages transparency and standardisation

  
  

  A well-defined common language benefits all stakeholders, from local manufacturers to foreign exporters and supports a more consistent regulatory environment in Malaysia.

What Manufacturers & Stakeholders Should Do Now

If you have medical devices, components, or spare parts relevant to the Malaysian market, now is a good time to:

1. Review your product portfolio; check whether any items you handle might fall under the new definitions.

2. Assess classification risk, especially items that might have been ambiguously classified in the past.

3. Prepare feedback if needed; if there are product categories or definitions unclear or potentially problematic, consider submitting comments to MDA before 18 December 2025.

4. Update documentation & submission templates; align your internal classification rules, labelling, master records and regulatory dossiers with the upcoming definitions.

   
   

5. Communicate with partners and ARs; ensure everyone involved in product registration and supply chain understands the updated definitions and adjusts operations accordingly.

📅 What’s Next?

MDA will review public comments submitted by 18 December 2025, possibly revise the draft based on stakeholder feedback, and then release a final version of the guidance. Once finalised, this document will become the reference for interpreting the definitions of medical devices, accessories, components and spare parts in Malaysia.

We expect this to impact new registrations, renewals, change notifications and import/export submissions going forward.

ARQon will continue to track and report on regulatory developments, helping clients and partners stay ahead of changes and remain compliant with Malaysia’s evolving regulatory framework.