Regulatory Reliance Practices in APAC
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.
Australia 🇦🇺
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)
Bangladesh 🇧🇩
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.
China 🇨🇳
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”.
Hong Kong 🇭🇰
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)
India 🇮🇳
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 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)
Indonesia 🇮🇩
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
Malaysia 🇲🇾
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)
Singapore 🇸🇬
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?
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)
South Korea 🇰🇷
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)
Sri Lanka 🇱🇰
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
Taiwan 🇹🇼
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)
Thailand 🇹🇭
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 in APAC 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:
Bangladesh, Hong Kong, India, Malaysia, Pakistan, Singapore, Sri Lanka, Thailand, Vietnam
Australia, Hong Kong, India, Malaysia, Pakistan, Singapore, Sri Lanka, Thailand, Vietnam
China (NMPA)
Hong Kong, Pakistan, Vietnam
Australia, Bangladesh, Hong Kong, India, Malaysia, Pakistan, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam
Australia, Bangladesh, Hong Kong, India, Malaysia, Pakistan, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam
Australia, Hong Kong, Sri Lanka, Thailand, Philippines
South Korea (MFDS)
Hong Kong, Pakistan, Vietnam
Switzerland (Swissmedic)
Pakistan, Vietnam
United Kingdom (MHRA)
Bangladesh, India, Pakistan, Vietnam
United States (FDA)
Australia, Bangladesh, Hong Kong, India, Malaysia, Pakistan, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam
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
At which stages of the product lifecycle is reliance practiced 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 |
Disclaimer
