Solution

Market Access Solutions

Entering The Asian Market

Multi-country market listing can be a headache for any medical device company. In addition to the workload of connecting with different companies, it is also exhausting to deal with the problems raised by local health authorities.

Qualtech provides you with multi-country registration solutions. For our clients, you only need to contact a single window and prepare just one set of documents, then, you will obtain marketing authorizations in multiple countries at the same time, and simultaneously expand the Asian market.

Markets you may be interested in

China, Japan, Vietnam, Thailand, Indonesia, Singapore, Philippines, Malaysia, Taiwan, HongKong

ASEAN AMDD Medical Device Regulation Comparison Table

	SINGAPORE	MALAYSIA	INDONESIA	PHILIPPINES	VIETNAM	Thailand
AMDD Compliance	Fully	Fully	Fully	New Regulation (Phase 1) commencement on March 13, 2020	New Regulation following AMDD will be implemented in 2022.	CSDT format for Class II (MD to be notified) and Class I (MD be licensed) & PMAS
Regulator	Health Sciences Authority (HSA)	Medical Device Authority (MDA)	Ministry of Health (MoH)	Philippines Food and Drug Administration (PFDA)	Ministry of Health (MoH)	Thai Food and Drug Administration (TFDA)
Laws	No. S 334 /2016 Health Products (Medical Devices) Regulation	Act 737 Medical Device Act 2012	MOH Regulation No. 62 year 2017 (Marketing Authorization License Manufacturer)	AO 2018:002 Circular 2020-001	Decree No. 36/2016/ND-CP & Decree No. 169/2018	Medical Device Act 2008 & 2019
Review by Conformity Assessment Body( CAB)	GDPMD/ISO 13485	ISO 13485/ GDPMD First Stage of PR	NA	NA	NA	NA
Who shall do the registration	Local Registrant	Authorized Representative (AR)	Local Importer	Importer	Local AR or Distributor	Importer
Classification	A, B, C, D	A, B, C, D	A, B, C, D	A, B, C, D	A, B, C, D	III, II, I
Validity of Certificate	Annual Retention	5 years	2~5years According LOA	CMDN (Class A): Permanent CMDR(Class B, C, D) : 5 years	Class A: Permanent Class B, C, D: 5 Years	Class I, II: 5 years Class III: according to FSC
QMS Requirements	ISO 13485	ISO 13485	ISO 13485	ISO 13485 Or local GMP equivalent	ISO 13485	ISO 13485 Or local GMP equivalent

Shortened Registration Timeline for High-risk Device

The lengthy process of performing clinical trials will prevent you from keeping up with the rapidly changing market. Sometimes the clinical trial report does not meet the requirements for review and will directly leads to restarting costly clinical trials.

Qualtech conducts clinical trials based on our abundant experiences making sure that the results will meet the requirements of local health authorities. We are familiar with the requirements and procedures in the Asian market, allowing you to use just one clinical trial report for multiple registrations.

Services you may be interested in

Clinical trial services, Product registration services

Exclusive Asian Regulatory Research Reports

Information in most Asian countries is provided in the local language, which prevents many medical device companies interested in entering the market from obtaining real-time information and then formulating a suitable market plan.

Qualtech can provide you with multi-regional regulatory research, market research, product standard assessment and competitive product search services, allowing your company to quickly grasp the environment of the target market, and formulate accurate and efficient market access strategies.