1. Benefits of Assigning a Neutral Consulting Company as your local Authorized Representative:
In this first section, we elaborate on some of the advantages for foreign manufacturers that come along with assigning a neutral 3rd party as their license holder in Asia/Oceania over their local distributor. Benefits are related among other things to:
ü Regulatory Compliance
ü Confidentiality
ü Flexibility
ü A One-Stop Solution for Multiple Countries
ü Faster Market Access
● 1.1. Regulatory Compliance - Ensuring Compliance and Staying Up-to-date with Any Changes:
When assigning a local consulting partner as your authorized representative (AR), your neutral AR will ensure that your licenses are up-to-date, valid, and that you comply with all newly implemented regulatory changes.
This, on the other hand, may not always be guaranteed when having a local distributor designated as your AR. Considering the potential impact and temporary suspension of sales, some distributors may try to avoid submitting the needed change application to the local health authorities. That is, even though they have been informed of changes concerning the registered product(s).
Unlike your distributor, a consulting company partner encounters no conflict of interest, and will provide you with timely information as well as an assessment of the regulatory impact on your existing product license.
● 1.2. Confidentiality - Keeping your Confidential Information and Submission Dossier Protected:
In case Qualtech is assigned as your AR and we assist you in preparing for product registration, you will not have to provide your confidential documents to different distributors to proceed the registration. In addition, Qualtech will share the final submission dossier with you, while maintaining any confidential documents in our own secured server with strict access control.
● 1.3. Flexibility - The Ownership of the Product License will belong to the Manufacturer instead of your Local Distributor:
Given that the manufacturer itself will own the license, it allows for much greater power in selecting your business partners and in negotiating better commercial terms. Your neutral consulting partner will only hold the licenses on your behalf, and will follow your instructions and authorizes designated distributors as per your request.
Assigning Qualtech also bears the benefit of reducing your costs, as you do not have to set up your own local branch office in the respective market to hold the license by yourself, in case you did not plan to have your distributor assigned as license holder. Furthermore, putting your license in Qualtech brings you more flexibility in changing your distributor, if needed. This, in turn, protects you from business loss due to a potential change in distribution partner.
● 1.4. One-Stop Solution - Qualtech as a Single Point of Contact for Multiple Countries in Asia/Oceania:
Since Qualtech has its own qualified and licensed offices and staff members located in each of our 11 service countries (Singapore, Malaysia, Indonesia, Vietnam, Thailand, the Philippines, China, Hong Kong, Japan, Taiwan, and Australia), you can utilize Qualtech as your single point of contact (SPoC) for any regulatory updates, communication, and license amendments with the respective health authorities. By having a single regulatory window instead of various distributor contacts in the Asian markets, the entire process is further greatly streamlined and simplified.
● 1.5. Faster Market Access – Utilizing the Same Documents for Multi-Country Product Registration:
Assigning Qualtech as your AR for multiple countries is further beneficial, as we can easily utilize one set of your product’s technical dossier (used for obtaining EU or US FDA approval) and proceed with multi-country submission/product registration in Asia. In case different requirements are in place among the different Asian countries, we will provide you with a Gap Analysis for the additionally required documentation for each market. In that way, we can utilize the documents submitted to us once, and you do not need to re-send most of the documents to us again for the next market. Ultimately resulting in a far more efficient registration process, which allows for quicker market access particularly to the various countries of the ASEAN region with reduced costs.
2. Summary of the Product License Conditions in ASEAN, Taiwan, Japan, Hong Kong, Australia, and China:
Table 1: License Conditions including Validity and Transfer Possibilities in ASEAN, TW, JP, HK, AU, and CH
Authority: |
Taiwan FDA |
Singapore HSA |
Malaysia MDA |
Indonesia MoH |
Philippines FDA |
Thailand FDA |
Vietnam MoH |
Hong Kong |
Australia TGA |
China NMPA |
Japan PMDA |
License Conditions: |
|||||||||||
License Transfer: Change of License Ownership is possible? |
Yes |
Yes |
Yes |
No*1 |
Yes |
No*1 |
- Import Permit: |
Yes |
Yes |
License is owned by the Mfr. |
License is owned by the Mfr. |
License Validity: |
- QSD: |
Unlimited, |
5 Years |
Subject to the Letter of Authorization from Legal Manufacturer to the AR: |
5 Years |
5 Years |
- Import Permit: |
5 Years |
Unlimited, as long as the Annual ARTG Fee is paid to TGA. |
- Class I: |
- Product |
Who shall do the Product Registration? |
Local AR |
Local AR |
Local AR |
Importer*2 |
Importer*2 |
Importer*2 |
- Import Permit: |
Local Responsible Person (LRP) |
Local AR (Local Sponsor) |
Local AR (Legal Agent) |
Local AR (DMAH) |
As indicated in the chart above, according to the regulations set by Indonesia, the Philippines, and Thailand, the applicant for the Product Registration License is required to also serve as the Importer for such medical devices (*2). This hence means that at custom clearance, the medical device License Holder (AR) is required to provide the company eligible licenses, to declare the imported goods by filling in the respective compulsory forms, and to show proof of payment at Custom’s request.
Accordingly, and in order to provide a one-stop solution to our clients, Qualtech can not only serve as your AR, but also as your importer in these three countries. Our local Qualtech branch offices have thus obtained all required licenses to serve in both roles. Qualtech’s Import Agency Services in Indonesia, the Philippines, and in Thailand include the processing of order placement, goods payment to import/custom clearance, and to distribute the post-market surveillance obligations among the manufacturer, distributor, and Qualtech via a Three-Party Agreement.
When considering to transfer an existing product registration license, nearly all markets above allow for a smooth transfer process without any hurdles. In fact, only Indonesia’s MoH and Thailand’s FDA do not permit a transfer for an existing product license (*1). Instead, the product would have to be registered again, in Indonesia specifically, the additional registration must be done under a different brand name and a different product category.
In Japan, a local (D)MAH – (Designated) Marketing Authorization Holder - needs to be assigned, while the product license is owned by the manufacturers themselves. However, the (D)MAH acts as a legal agent, is responsible for domestic quality control, conducts final product inspection and release, and does post-market surveillance.
If you would like any additional information or have any queries concerning Authorized Representative Services, please don’t hesitate to contact Qualtech’s Business team at any time. We will be more than happy to address any questions that you may have or to set up an initial call with you.
● 2.1. Locations and Qualtech Offices: