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Regulatory Reliance initiative Tracker 2025

Regulatory Reliance initiative Tracker 2025

This tracker maps existing regulatory reliance pathways across the Asia-Pacific region. It presents the reference markets accepted by each APAC regulatory authority and the markets that can be accessed through approval in those reference markets. The aim is to support greater transparency, facilitate collaboration among regulatory authorities, and help all stakeholders identify opportunities to streamline regulatory processes and improve patient access to safe medical technologies.

Referenced Authorities APAC markets

Discover which reference countries are accepted by each APAC regulatory authority to support market approval, providing insight into reliance or recognition pathways used across the region.

Hover over the map to view different market, and click for more details.

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Abridged review; Work sharing (e.g. MDSAP)

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Pre-market registration; Quality Management System (QMS)

What types of post-approval changes are covered under reliance mechanisms?

Both

Which reference markets does your regulatory authority rely on?

European Union (EU); Japan (PMDA/MHLW); United States (FDA); Singapore (HSA); Canada (Health Canada)

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

Pre-market: 1 month if application has no risk factors. If application has risk factors, 9–12 months. List of official risk factors are defined by TGA and reviewed on an annual basis. (Official guidance documents from TGA on their audit framework is expected in July 2025).

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

Is your market currently regulated for GMD?

Partial regulation

Is your market currently regulated for IVDD?

Partial regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Informal or ad hoc practice

What types of regulatory reliance mechanisms exist in your market?

Recognition (unilateral or bi/multilateral)

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Pre-market registration; Post approval changes; Quality Management System (QMS)

What types of post-approval changes are covered under reliance mechanisms?

Both

Which reference markets does your regulatory authority rely on?

Australia (TGA); European Union (EU); Japan (PMDA/MHLW); United States (FDA); UK

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

6 months

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

There is no official website link. Our regulatory authority has inform us what type of regulatory documents they will accept and from which country. At time of registration application we submit hard copies of such documents.

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

No

No formal mechanism between regulators, but some ongoing practices: CMDE has the guidelines “Acceptance of overseas clinical trial data”.

Is your market currently regulated for GMD?

Voluntary regulation

Is your market currently regulated for IVDD?

Voluntary regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Abridged review

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Pre-market registration/pre-market product approval (including QMS & clinical)

What types of post-approval changes are covered under reliance mechanisms?

Not applicable

Which reference markets does your regulatory authority rely on?

Australia (TGA);Canada (Health Canada);European Union (EU);Japan (PMDA/MHLW);United States (FDA);China (NMPA);Singapore (HSA);South Korea (MFDS)

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

According to the Guidance Notes (GN-02 & GN-06), the vetting and approval of an application for listing a device should normally be completed within 12 weeks following the submission of the application and all the required supporting information, including labelling samples.

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Abridged review

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Clinical/Pre-market product approval, QMS, Clinical

What types of post-approval changes are covered under reliance mechanisms?

Not applicable

Which reference markets does your regulatory authority rely on?

Australia (TGA);Canada (Health Canada);European Union (EU);United States (FDA);Japan (PMDA/MHLW);United Kingdom

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

9 months

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

No

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Recognition (unilateral or bi/multilateral)

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Clinical; Pre-market registration; Quality Management System (QMS)

What types of post-approval changes are covered under reliance mechanisms?

Not applicable

Which reference markets does your regulatory authority rely on?

Australia (TGA); Canada (Health Canada); European Union (EU); United States (FDA); Japan (PMDA/MHLW)

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

https://portal.mda.gov.my/index.php/doc-list/circular-letter Refer to #1: Conformity Assessment Procedures for Medical Device Approved by Recognized Countries (Circular Letter No.: 1/2025)

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Abridged review; Work sharing (e.g. MDSAP)

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Pre-market registration;
Quality Management System (QMS)/Pre-market product approval, QMS, Clinical, Post Market Changes (ie. Intended use/Indication for use)

What types of post-approval changes are covered under reliance mechanisms?

Not applicable

Which reference markets does your regulatory authority rely on?

Australia (TGA);Canada (Health Canada);European Union (EU);Japan (PMDA/MHLW);United States (FDA)

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Abridged review

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Quality Management System (QMS)

What types of post-approval changes are covered under reliance mechanisms?

Not applicable

Which reference markets does your regulatory authority rely on?

MDSAP certification, not specific countries

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

The MDSAP route is 2–4 months faster than the standard KGMP process, especially if an on-site audit is required.

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Recognition (unilateral or bi/multilateral)

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Clinical; Pre-market registration; Post approval changes; Quality Management System (QMS); Vigilance

What types of post-approval changes are covered under reliance mechanisms?

Both

Which reference markets does your regulatory authority rely on?

Australia (TGA); Canada (Health Canada); European Union (EU); Japan (PMDA/MHLW); United States (FDA); Singapore (HSA);

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

8–10 months

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

https://www.nmra.gov.lk/announcements Draft guideline for the Consolidated Dossier New Application Submission and Evaluation of General Medical Devices and IVDD

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Abridged review

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Pre-market registration; Quality Management System (QMS)

What types of post-approval changes are covered under reliance mechanisms?

Not applicable

Which reference markets does your regulatory authority rely on?

United States (FDA); European Union (EU); Japan (PMDA/MHLW)

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

3–6 months for QSD (site registration)

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

Is your market currently regulated for GMD?

Full regulation

Is your market currently regulated for IVDD?

Full regulation

Does any form of regulatory reliance currently exist in your market?

Yes

What is the legal basis for the reliance model in your market?

Codified in regulation or official guidance

What types of regulatory reliance mechanisms exist in your market?

Abridged review

At which stages of the total product lifecycle (TPLC) does reliance apply in your market?

Pre-market registration

What types of post-approval changes are covered under reliance mechanisms?

Not applicable

Which reference markets does your regulatory authority rely on?

Australia (TGA); Canada (Health Canada); European Union (EU); Japan (PMDA/MHLW); United States (FDA); Singapore (HSA)

Based on your experience or publicly available data, what is the typical regulatory turnaround time (TAT) for reliance pathways in your market?

50% – 75% shorter time than normal timeline

Please provide the official website link(s) to the official document(s) that support the reliance pathways in this market (for reference purposes)

Markets Accessible via
Reference Authority Approval

Explore what APAC markets you can access by obtaining regulatory approval by a specific referenced authority, helping you plan efficient submission strategies based on reliance opportunities.

List of markets:

What kind of reliance models
exist in APAC​

Country Abridged Pathway Work Sharing Regional Reliance Unilateral Recognition Mutual Recognition
Australia
Japan
Vietnam
Singapore
India
Thailand
Malaysia
South Korea
Philippines
USA
EU
Canada
Brazil
UK

* The eSTAR Pilot between Canada and US is for pre-market submission but not a formal pathway yet
**Reliance for general medical devices only, not for IVDs

Which product lifecycle
do we practice reliance in APAC​

Total Product Lifecycle Markets with formal reliance mechanism
Pre-market registration 🇦🇺 AU | 🇮🇳 IN | 🇲🇾 MY | 🇵🇭 PH | 🇸🇬 SG | 🇹🇭 TH | 🇻🇳 VN | 🇺🇸 US | 🇨🇦 CA | 🇧🇷 BR | 🇪🇺 EU | 🇬🇧 UK
QMS 🇦🇺 AU | 🇮🇳 IN | 🇲🇾 MY | 🇵🇭 PH | 🇸🇬 SG | 🇹🇭 TH | 🇻🇳 VN | 🇰🇷 KR | 🇺🇸 US | 🇨🇦 CA | 🇧🇷 BR | 🇪🇺 EU | 🇬🇧 UK
Clinical 🇦🇺 AU | 🇮🇳 IN | 🇲🇾 MY | 🇵🇭 PH | 🇸🇬 SG | 🇹🇭 TH | 🇻🇳 VN | 🇰🇷 KR | 🇺🇸 US | 🇨🇦 CA | 🇧🇷 BR | 🇪🇺 EU | 🇬🇧 UK
Post-approval changes 🇦🇺 AU | 🇹🇭 TH
Vigilance

The eSTAR Pilot between Canada and US is for pre-market submission but not a formal pathway yet
The UK reliance proposal for MDs/IVDs is currently under public consultation (link)
Huge variation in reliance practice creates great opportunities to improve existing reliance mechanism even if they check the boxes

Disclaimer

The information presented in this tracker is based on publicly available sources and verified inputs from APACMed members and partners. It is intended to provide a high-level overview of regulatory reliance practices in the APAC region and does not reflect any official regulatory position. Users are encouraged to consult directly with the relevant authorities or official regulatory documents for the most up-to-date and detailed requirements.
 
Last updated on July 2025.
 
Click here to view or download the full tracker.
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