In this article, Qualtech gives you an overview of the express routes you definitely want to grab to register your medical device products in ASEAN and Hong Kong. 

Singapore’s Accelerated Routes
As early as August 2018, the Health Science Authority (HSA) of Singapore has already implemented the fast-track review of class B-D Medical Devices in three types: (1) abridged, (2) expedited and (3) immediate.

 

Route	Requirements/Conditions	Previous Turn-Around Time	Fast-Track Turn-Around Time
Abridged	Approval from at least one of HSA’s overseas reference regulatory agencies	Full Class B: 160 Working Days Class C: 220 Working Days Class D: 310 Working Days   Full (Priority Review) Class B: 120 Working Days Class C: 165 Working Days Class D: 310 Working Day	Class B: 100 Working Days Class C: 160 Working Days Class D: 220 Working Days
Expedited (ECR – 1) for Class C	1. Approval from at least one of HSA’s overseas reference regulatory agencies. 2. Marketed for at least three years in Singapore, or in the respective agencies' jurisdictions. 3. No safety issues globally. 4. No prior rejection/withdrawal by HSA or any overseas reference regulatory agencies		Class C: 120 Working  Days Class D: 180 Working Days
Expedited, ECR – 2, for Class C and EDR for Class D	1. Approval from at least two of HSA’s overseas reference regulatory agencies. 2. No prior rejection/withdrawal by HSA or any overseas reference regulatory agencies
Immediate (IBR) for Class B	Condition 1: 1. Approval from at least one of HSA’s overseas reference regulatory agencies. 2. Marketed for at least three years in Singapore, or in the respective agencies' jurisdictions 3. No safety issues globally 4. No prior rejection/withdrawal by HSA or any overseas reference regulatory agencies Condition 2: 1. Approval from at least two of HSA’s overseas reference regulatory agencies. 2. No safety issues globally 3. No prior rejection/withdrawal by HSA or any overseas reference regulatory agencies		Immediately Upon submission
Immediate for Standalone Medical Mobile Applications for Class B and C	1. Approval from at least one of HSA’s overseas reference regulatory agencies. 2. No safety issues globally 3. No prior rejection/withdrawal by HSA or any overseas reference regulatory agencies

 

ASEAN New Express Route 1. Malaysia’s Special Access Routes
In May 2020, Malaysia opened two special routes for the registration of medical devices. Route A is for medical devices to be used in emergency situations that pose immediate risk to the patient’s life. Route B is for compassion-based medical equipment, for medical devices used to relieve shortage situations, for the design and/or operation that will most likely support or improve the outcome of a patient’s operation or treatment, and for COVID-19 Test Kits Special Access Notification.

 

ASEAN New Express Route 2. Thailand’s HSA Special Reliance Program
Thai FDA currently provides three expedited routes as follows:

1. HSA Reliance program- Class 4 Medical Device for HSA,  both IVD and Non-IVD, which are already registered in Singapore. This shortens the review period from 150 days to 60 days. This was officially implemented last October 2021. You may check out Qualtech’s November article on this subject.

2. Fast track for COVID-19 related products. Check out the list of products that belong to this category. The regulation for this is in force since August 2021.

3. EUA Route for COVID-19 Kits. This route is available since May 2020.

 

ASEAN New Express Route 3. Philippines’ Abridged Registration Route
Last November 2021, PFDA implemented a priority review for all Class B-D Devices with prior full-asessment via the unabridged route in any ASEAN country. The applicants are still required to submit the CSDT. PFDA is set to issue further guidelines with regards to the difference in turn-around time and other fineprints. Special certifications are issued for COVID Test Kits but are required to undergo technical evaluation from the national reference laboratory. COVID-related products are also given priority but the requirements and manner of submission are the same.

 

ASEAN New Express Route 4. Vietnam
Starting this January, Class C/D medical devices can be registered in an accelerated route provided that (1) the medical device has one granted CFS (Certificate of Free Sale) or MA (marketing authorization) from reference countries, including US, Canada, Japan, Australia, EU countries, England, Switzerland, China, and Korea, and/or (2) it has been granted with an Import Permit. From 40-45 days, the review period will become 10 working days. COVID-related products are also qualified for this route.

 

New Express Route 5. Hong Kong
Also January of this year, MDD announced that the expedited approval scheme for Class II/III/IV General Medical Device Listing Applications will become a regular offering. Last year, MDD opened this route initially as a trial or pilot run. Originally, applicants can only choose 2 products to register using this scheme. In November, MDD lifted the restriction on the number of applications allowed and gave LRPs until December 31^st to submit. By 04 January 2022, this expedited route was normalized. No specific change in turn-around time was yet specified in the announcement, but it is expected to be shorter than the regular review period.
 

If you have questions or doubts on whether your medical device products can take advantage of these fast-track routes, do not hesitate to contact our Business Team so we can assist and consult with you.

 

 

References:

1. Singapore HSA Registration Guides
2. Hong Kong MDD Note for the Expedited Approval Scheme