On November 27, 2025, Qualtech successfully wrapped up its 2025 webinar series with the final installment of the Southeast Asia Medical Device Compliance Update. This session, Part 2, shifted focus from Indonesia, Thailand & Vietnam to the three markets currently undergoing the most dynamic regulatory change in ASEAN: Singapore, Malaysia & the Philippines.

The session delivered market-specific insights on major transitions, evolving submission pathways, reliance mechanisms, and new regulatory requirements expected to influence compliance strategies in the coming year.

 

1. Singapore Updates:

Singapore's regulatory landscape underwent important changes in 2025, driven by a major system upgrade and several extensive guidance document revisions.

1.1 Migration from MEDICS to SHARE

The transition from MEDICS to the SHARE system, completed on 4 July 2025, introduced more structured workflows and improved oversight. Notable enhancements include:

• More structured Class A notifications
• Applicants can directly request access for a 3rd party company
• Importer tagging with importer acknowledgment
• Applicants can submit cancellation applications and specify the effective cancellation date
• Automatic retention reminders 30 days before device retention due date
• Clearer tracking of Fulfillment of Approval Conditions (FoAC)

 

1.2 Singapore–Malaysia Regulatory Reliance Pilot

A six-month pilot of the bilateral regulatory reliance program, running from 1 September 2025 to 28 February 2026, streamlines the registration process of Class B, C and D medical devices between both countries.

• Singapore to Malaysia: HSA-registered devices may undergo Malaysia's verification route (abridged review pathway) through MDA's Conformity Assessment Body (CAB) with a review time of only 30 working days.
• Malaysia to Singapore: MDA-registered devices may receive up to 30% shorter HSA review timelines under the abridged pathway.

 

1.3 Updated HSA Guidance Documents

• HSA issued major updates through several regulatory documents, including:
• Change Notifications (GN-21-R6)
• Guidelines Risk Classification SaMD and CDSS (GL-07-R2)
• Regulatory Guidelines for Laboratory Developed Tests (GL-08-R2), which restricts advertising of LDTs to the general public
• The Process regarding the Change of Registrant (GN-24-R2)
• Importation for exhibitions (GN-32-R6)
• FSCA requirements (GN-10-R4)
• Special Access Routes (GN-35-R5)
• Preparation of a Product Registration Submission for General MD or IVD MD using the ASEAN CSDT

 

2. Malaysia Updates:

Malaysia continues to reinforce regulatory co2ntrol, strengthen supply-chain governance and align more closely with ASEAN standards.

2.1 New Import Permit Requirements (Effective 2 January 2026)

Import permits will soon be required for:

• All registered medical devices, exempted medical devices (MEDC@ST), and exempted Medical Device Manual (Personal use, IRE)

A Verification Slip will be issued to Non-Medical Devices:

• Share with Medical Device Harmonized System (HS) Code
• No approval under MDA's law is required

Key implementation points include:

• ePermit applications must be submitted at least seven days before shipment
• Each permit is valid for one shipment, expires after 90 days, and allows for a maximum of 99 Stock Keeping Units (SKUs).

 

2.2 Import-for-Re-Export (IRE)

The IRE pathway allows temporary importation of a medical device into Malaysia only for the purpose of re-exporting it to another country, without placing the device on the Malaysian market.

• Apply at least 21 days from the date of importation
• 14 working days processing time per application
• Letter validity of 12 months
• Mandatory export before the expiration of the IRE Approval Letter
• Any misuse of the IRE approval may result in penalties

 

2.3 Registration Pathways and Verification Route

Malaysia clarified the key routes for device registration:

• Class A: Direct submission application to MDA via MeDC@St.
• Class B to D: Undergoes CAB evaluation for conformity assessment plus MDA review. Alternatively, evaluation via way of simpler CAB verification applies to devices approved in recognized markets, such as the US, EU, UK, Japan, Canada, Australia, Singapore &Thailand.

 

2.4 ASEAN Borderline and Classification Updates

The updated list of harmonized borderline products in ASEAN now includes over 200 devices and refined risk classifications. These improvements support consistent interpretation across the region and reduce misclassification risks.

 

2.5 Cross-Border Reliance Programs

Malaysia is participating in two reliance program initiatives:

• A bilateral pilot with Singapore for review acceleration.
• A Malaysia–China regulatory reliance pilot for IVDs, with its first phase having lasted from 30 July 2025 to 30 September 2025, referencing NMPA approvals. This pilot was primarily for Chinese-made IVDs and explicitly excludes third-party brand owners.

 

2.6 Class A Fee Revision (Effective 1 January 2026)

Revised Class A fees include an RM 500 application fee and an RM 750 registration fee. Stakeholders were advised to complete 2025 submissions before 10 December.

 

3. Philippines Updates:

The Philippines continues its transition toward AMDD alignment, introducing updated drafts for the IVD regulation as well as reforms regarding software and classification requirements.

3.1 Draft IVD Regulation

The draft IVD regulation introduces a modernized framework featuring the so-called Certificate of IVD Registration (CIVDR) and a product risk classification based on AMDD Annex 3. Full implementation is targeted for 2026.

 

3.2 Updated List of Registrable Devices

Key clarifications under AO 2018-0002 and supporting circulars include:

• CMDN transitioning to CMDR upon expiry
• Starting from October 1, 2024, all manufacturers, traders, exporters, importers, and distributors of Medical Devices that are not included in the List of Registrable Medical Devices shall apply for CMDR for Class B, C, and D MDs.

 

3.3 Draft Guidelines for Medical Device Software

The new guideline outlines classification and the specific legal and technical requirements for initial and renewal authorization applications of MDSW. The application procedure for initial registration of Class B, C, and D MDSW is outlined in Annex G*. While Class A MDSW initial registration applications shall be submitted through the FDA eServices Portal System. Abridged pathways may apply for ASEAN-approved devices.

 

3.4 PFDA Turnaround Times

The PFDA published turnaround times (TATs) remain:

• Class A – 24 working days
• Class B – 80 working days
• Class C/D – 100 working days)
• Devices eligible for abridged pathways may obtain approval in 20 working days.

 

This session concludes the Southeast Asia Medical Device Compliance Update Series and marks the successful completion of Qualtech's 8 webinars in 2025. The insights shared reflect a region that is evolving at a rapid pace and underscore the growing importance of having timely, accurate, and actionable intelligence to stay ahead.

Qualtech is hence fully committed to supporting our clients with reliable, country-specific guidance and end-to-end market-access solutions across the entire APAC region.

We look forward to continuing the journey with you in 2026 and beyond, bringing the local expertise and practical support that help you turn regulatory change into real business advantage. For any inquiries, please reach us at globalra@qualtechs.com