THAI FDA REGULATORY AGENCY: 8 key factors you should consider
Choosing your Thai FDA Regulatory Agency is the first step for your healthcare project in Thailand.
Many believe that licensing and registering their medical devices, dietary supplements or cosmetics is like grocery shopping. Every day we receive contacts from people who have a contradictory approach, presenting themselves with information taken from the web and with a list of actions to be carried out on their behalf. Practically with a shopping list…
The time has come to shed some light on this sector in which the internet contributes very little, complying in most cases with the result of spreading false news and confusion.
In order to choose the right Thai FDA Regulatory Agency you should take into account the following factors:
1 – The Thai FDA Regulatory Agency is not your executor, but your guide
Unless you have real direct experience of registering products in Thai FDA, you should avoid the do-it-yourself approach. The object of the regulatory consultancy is not to execute your requests by delivering documents to Thai FDA, but to implement a strategy that includes the company set-up, the choice of your office and warehouse, and the persons involved. Before talking about licenses (and costs), the consultant must have all the corners of your project clear, and draw all the steps with you. If the consultant agrees to act as a simple “messenger” by delivering the given documents at a given price without going into detail, well, why not to choose a real messenger?
2 – Obtaining Thai FDA licenses is not a question of costs but of professionalism and method
Most of our contacts start at the first email asking “how much does it cost to get a license in Thai FDA?” This is a risky approach: the price is of course an important component in your project, but not the main one. The main one is success, and the first question a professional consultant would like to hear is “is my project capable of obtaining Thai FDA licenses?” Everything else comes later.
3 – Much of the information on the internet is outdated
Our first and only sources of information are Thai FDA provincial offices and the headquarters of the Ministry of Health in Nonthaburi, that we visit twice a week. We periodically monitor the web and notice that the majority of regulatory agency and law firm sites provide widely oudated information. For example, from February 15, 2021, the new procedure for the registration of Medical Devices in Thailand is in force (according to the AMDD ASEAN Medical Device Directive), drastically changing the submission scheme. We anticipated this event in November 2020 in this article (we were the only site to have done it):New Procedure for Registration of Medical Device in Thai FDA and we will discuss extensively in a future article. But, most of sites are still proposing the procedure dated 2014.
Surely the professionalism of a regulatory consultancy agency is not judged by a site, but those who, for example, still talk about the classification of medical devices into 3 classes (classification dating back to before 2018), certainly does not contribute to clarifying the sector.
4 – Are you looking for a Thai FDA Regulatory Agency or a distributor?
Many of our contacts ask us to register their products in Thai FDA, but in reality they are looking for a customer. Better to clarify this aspect from the start: hoping that a regulatory agency, even if proposing license holding services, can sell your product is like hoping that the dealer you buy the car from will become your chauffeur: highly unlikely.
Regulatory and commercial are two activities at the antipodes, and unless you put yourself in the hands of a corporate with hundreds of employees and a network of salespeople already active in the area, you will find yourself spending money to register products that won’t be sold. Our main rule is: you drive the marketing, we give you the tools and we assist you so that you do not have road accidents.
5 – Verify that your regulatory advisor is physically present in Thailand
We are often contacted by foreign regulatory agencies (most of them from USA and Singapore) who request us “collaboration” that never materializes. Their sole purpose is to collect summary information on Thai FDA registration procedures and resell it to their foreign client, and then having the job done on site by an underpaid freelance consultant (the “messenger” mentioned in chapter 1). Those who do not have a registered company in Thailand are NOT accredited to operate in Thai FDA and cannot operate in any way as a license holder.
This means that while you pay, for example, a Singaporean agency believing that you are in safe hands, an individual you are not aware of is working on your behalf in a country where you currently have no representation, with serious risks to your intellectual property. Always ask your regulatory consultant to provide you with a certificate of his company in Thailand or to know who he relies on locally. A fundamental question to understand who you are dealing with may be: “when was your last visit to the Thai FDA?”
6 – Problem solving ability: a fundamental factor for the registration of healthcare products
The registration of products in Thai FDA is governed by laws that leave wide discretion to Thai FDA officials in the evaluation of dossiers. This means that regulation in Thailand is not an exact science and has infinite variables.
This is especially true in the case of Medical Devices (with a similar percentage for food supplements), where discretion is also enshrined in the ASEAN Medical Device Directive. Therefore each application has a story of its own and will be subject to a different set of additional documentation. In this case, direct experience in Thai FDA is essential. Many of the ongoing certification problems are due to product communication rather than technical factors. As mentioned in the first paragraph, if the regulatory work was a mere passing of documents, you would be able to do it yourself and you would not need a regulatory agency.
7 – Collateral services: company incorporation, dedicated office, warehousing…
If your business focuses on the import of healthcare products licensed by the Thai FDA, it is best to take this into account from the real beginning. Unfortunately, it is a common approach to have a generic company opened by any law firm and then discover that what has been done is not compatible with your project. This is because there is often no knowledge of what will be necessary to obtain licenses in Thai FDA and therefore the project setting is not specific.
In practice, this will result in lengthy and costly changes to the corporate assets, the company objective, the change of managing director, the need to hire qualified personnel, often even having to change the company headquarters because it is not compliant.
The temptation to save money by choosing a common virtual office often conflicts with the requirements of Thai FDA (and of the Revenue Department), and you will have to rent a new office or accept expensive upgrades. Thinking about it first is the best choice and the really cheapest one in long term.
8 – Last but not least: clarity and transparency are essential
We have so far seen how the choice of the right Thai FDA Regulatory Agency is the first step for the success of your project. Ask the right questions, investigate all aspects of your project and share all the details to have a relationship of trust with those who will probably accompany you for years on your adventure. Investigate, understand who you are facing; before talking about price, ask for past performances, references, current and past projects, and verify their records. Be ready to provide same information about you, keeping in mind that your consultant will use his reputation to support your project. After that, ask for the price.
Contact us today for more information on the Regulatory in Thailand.