Panayam kay Atty. Pamela Sevilla ukol sa pagpapatibay ng medical devices classification sa bansa at pagbubuo ng Task Force Obsidian ng FDA

1 year ago

Panayam kay Atty. Pamela Sevilla ukol sa pagpapatibay ng medical devices classification sa bansa at pagbubuo ng Task Force Obsidian ng FDA

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Transcript

00:00to strengthen the medical device classification in the country

00:04and the creation of a task force obsidian by the FDA.

00:08We will discuss this with Atty. Pamela Sevilla,

00:11the spokesperson of the Food and Drug Administration.

00:14Atty. Sevilla, good afternoon.

00:17Good afternoon to all who are watching and listening to us.

00:22Atty., first of all,

00:23what are the steps of the Food and Drug Administration

00:27to strengthen the medical device classification in the Philippines?

00:32First of all, in the commitment to safeguard public health

00:36and to enforce strict regulatory standards,

00:39the Food and Drug Administration

00:41through the leadership of our Director General, Samuel A. Zacate,

00:45created a task force called the Task Force Obsidian.

00:49We named this after the first medical device in the whole world

00:55made of obsidian material.

00:57So with this, as early as 2020,

01:01we also had issuances

01:04for the stakeholders and our consumers

01:08to discuss the classification of the medical devices

01:11that we are buying and using.

01:13As a bank,

01:15now in 2024,

01:17we saw the importance of how to bring this to our public,

01:23so that they will know the classifications

01:28that I mentioned, using medical devices.

01:33What is the primary objective of the creation of this Task Force Obsidian?

01:39And what will be its key responsibilities

01:42in the regulations of the medical device classification in the country?

01:47First of all, we thought of creating a task force

01:50and to introduce it to the public

01:52because we saw a problem.

01:54This problem stemmed from the approval or registration

01:59of our stakeholders for medical devices.

02:02The most common encounter of the FDA

02:05is that our stakeholders or applicants are not sure

02:09about the classification of the medical devices that they are using.

02:13With this regulation,

02:15we can see the classifications.

02:18Based on the ASEAN Medical Device Directive,

02:21we have a classification, A to B,

02:24which is low-risk medical devices

02:27up to high-risk medical devices.

02:30Before applying to the FDA,

02:33every stakeholder should know

02:36so that they can apply correctly.

02:39The downside or negative effect to the public

02:44is that if our consumers or the public

02:48buy the wrong classification of medical devices,

02:51they will not be able to go to the serendipitous administration.

02:56So how does the FDA plan

02:58to coordinate with the medical device industry in the country

03:03regarding the development of new guidelines

03:06that the task force is building?

03:08Even though we have a zero-contact policy

03:11with our clients or applicants,

03:14we hold conventions or conferences

03:18and even meetings with every medical industry in the Philippines.

03:23With this, we are asking them to bring new regulations or policies

03:29for them to comply and for them to strictly comply with our regulations.

03:34Because here in our country,

03:36most of the medical devices come from international or other countries.

03:41Before this came into force,

03:43the ASEAN Medical Devices Directive was still required

03:48and they should know about it.

03:50That's why the medical device industry is of great importance

03:54even though it's not that popular

03:56in the name of the Food and Drug Administration

03:59or in the name of our consumers.

04:01That is regulated by the Food and Drug Administration

04:04in the knowledge of all.

04:05Because our public may not know

04:09even our face masks, even our gloves,

04:12even those paraphernalia in hospitals

04:16should be regulated by the Food and Drug Administration.

04:19So the importance of this regulation that should be brought to us

04:23and to tell us that they have to comply

04:28with our regulations is the most important for us.

04:33Ernie, what are the challenges that you are facing

04:38in implementing these new policies up to now?

04:42The challenges, again, in the past,

04:44we have encountered this.

04:47Because if the stakeholder doesn't know the classification of the medical device

04:51that they are applying,

04:53what we see is that there is a tendency that they will not apply

04:56because of the confusion of what classification

05:00or what risk they are applying.

05:04But then again, we always say that

05:08the ASEAN Medical Device Directive

05:11is there for a long time.

05:12Even without our regulation,

05:14we are following the ASEAN Directive.

05:19So even without our policies and regulations,

05:21the stakeholders should decide

05:23what they are complying with.

05:25We are here to assist them,

05:28to also guide them,

05:29so that they don't get lost in the right track

05:32of what is the right classification

05:35that they should apply for.

05:38What do you think will be the impact

05:41on public health and safety

05:43of the implementation of this Task Force Obsidian?

05:47The impact on health, of course,

05:49we will make it stronger

05:51and we will make sure that all medical devices

05:54that will be applied,

05:55if the classification that they will apply is correct,

05:58their products will be safe and quality.

06:01If they cannot comply with the classifications,

06:05therefore, we cannot be sure

06:07of their safety and quality.

06:10That's why we are issuing policies

06:13also to safeguard the public

06:15and make sure that everything they buy in the market

06:18is safe and effective.

06:20Okay. Thank you very much for your time,

06:23Atty. Pamela Sevilla,

06:24spokesperson of the Food and Drug Administration.

Panayam kay Atty. Pamela Sevilla ukol sa pagpapatibay ng medical devices classification sa bansa at pagbubuo ng Task Force Obsidian ng FDA

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