Vietnam produced covid-19 Test Kit and Regulation for the Importation of Test Kits during the pandemic

covid-19

Scientists in Vietnam have successfully manufactured an in vitro (kit) real-time RT-PCR to detect novel coronavirus (SARS-CoV-2), which has been shown to deliver highly accurate results within 1 hour

On 5th March, The Ministry of Science and Technology announced that scientists in Vietnam had successfully manufactured an in vitro (kit) real-time RT-PCR to detect novel coronavirus (SARS-CoV-2), which was shown to be highly accurate with result within 1 hour. Vietnam could manufacture 10,000 kits per day with productivity reaching three times that if required.

The manufacturing process strictly follows quality requirements for medical device manufacturing, ISO 13485. The testing laboratory also follows ISO Class 8. The kit has been tested for its accuracy, sensibility, specificity, repeatability and compared with the kit provided by the US CDC and WHO. The Ministry of Health released Decision no. 774/QĐ-BYT to circulate the list of 02 IVD products for detection of SARS-CoV-2 in Vietnam. The productivity could serve the domestic requirement and production by order for sponsorship of many other countries. Vietnam has become one of the few countries that can produce the test kit, alongside the WHO, Japan, Germany and China.

The Ministry of Health also issued the dispatch no 1592/BYT-TB-CT regarding the manufacturing and importation of the SARS-CoV-2 test kit in which, the MOH encourages companies, importers and manufacturers to manufacture and import medical devices and IVD products related to the detection of SAR-CoV-2. For test kits used for sponsorship or donation, the import license could be approved through a special route: medical devices for sponsorship, aiding and donation, according to Decree 169/2018/ND-CP. For test kits to be used with medical devices, without sponsorship or donation, it is required that they have an import license according to Circular 30/2015/TT-BYT. For independent test kits (IVDs), it is required to have importation permission in accordance with Circular 47/2010/TT-BYT on the Import and Export of Pharmaceutical Products and Packaging Directly Connected With Pharmaceutical Products, IVDs part.

2020-05-01T06:02:02+08:00 March 31st, 2020|Event, Insight, News & Events|

Indonesia: Special Access Scheme (SAS) related to Covid-19

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The Ministry of Health (MoH) Indonesia announced through their website that a number of medical devices or household devices can be prioritized or accelerated for license approval for the purpose of preparedness handling of COVID-19.

Due to the current pandemic situation caused by the novel coronavirus, better known as COVID-19, the government of Indonesia has responded by changing its current status to “COVID-19 Emergency Response”. To facilitate an effective response to this pandemic, the government is providing some leeway with regard to the process of registering several products that are indispensable during this pandemic.

The Ministry of Health (MoH) announced through the registration website a list of medical devices or household devices for which the approval license is being prioritized or accelerated for the sake of preparedness handling of COVID-19, including:
1. Surgical apparel (masks, personal protective equipment, medical goggles)
2. Liquid chemical sterilant/high level disinfectant (disinfectant, hand rub, hand scrub)
3. Surgeons’ gloves (sterile gloves)
4. Patient examination gloves (examination gloves)
5. Clinical electronic thermometer (thermometer)
6. Ventilator
7. Transport culture medium
8. Microbiological specimen collection and transport device (Dacron swab)
9. Antiseptic (hand sanitizer)

In addition to the acceleration of new registration of the products mentioned above, the MoH has also issued a special access scheme (SAS) giving special access to medical devices that are urgently needed in Indonesia. The SAS allows the government to bypass the need for a distribution permit for importation, according to the Regulation of the Minister of Health of the Republic of Indonesia Number 51 of 2014 concerning the importation of medical devices through the SAS.

Medical devices that can be entered through the SAS must meet the following criteria:
a. provides maximum benefits for society and the country
b. pays attention to national needs and stock
c. meets safety and benefit standards and requirements
d. supports government policies in the health sector
e. is from an official source
f. has scarce availability
g. there are no similar products available
h. is incidental and not for regular use, and/or
i. is not for commercial purposes.

SAS licenses are divided into two types: namely SAS Donations and SAS Non-Donation.

SAS Donations can only be intended for the needs of health services, government programs in the field of health, research and development, and/or prevention of outbreaks, epidemics, or disasters. The MoH accepts SAS requests for products as mentioned above.

Whereas SAS Non-Donation can only be intended for special use needs at the request of doctors, government programs in the field of health, research and development, education and training, and/or national-scale health exhibitions. For now, the only SAS Non-Donation license approved by the MoH is that for a COVID-19 Test Kit.

The fee for obtaining the SAS permit is IDR 750,000. During this pandemic the application for a marketing authorization and SAS permit can be processed within hours if the required documents are completed.

2020-03-31T16:34:53+08:00 March 29th, 2020|Insight, Medical Regulation Updates, News & Events|

Vietnam: Standards Inspection on Class A Medical Device – Hand Sanitizer

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Some hand sanitizer products intended for non-medical purposes have been used as a Class A medical device. Therefore, the Health Environment Management Agency has implemented an official dispatch to review administration regulation of this product.

The world is still going through a major health crisis with the spread of COVID-19 and Vietnam is not excluded. The high demand for products such as face masks, gloves and hand sanitizer has led to some negative impacts.

In particular, some hand sanitizer products, which are intended for non-medical purposes, have been used as a Class A medical device. The Health Environment Management Agency implemented an official dispatch with the intent to review administration regulation for this type of product.

Chemicals and preparations which are used only for sterilizing medical equipment shall be managed according to the regulations in Decree 36/2016/ND-CP, issued 15/05/2016. Chemicals and preparations which are used not only for sterilizing medical equipment but also for other purposes shall be managed according to laws pertaining to chemicals and/or preparations intended for killing insects and bacteria for domestic and medical use. Thus, these kind of hand sanitizer products that are for non-medical use are subject to Circular 09/2018/TT-BYT issued 27/04/2018 and managed by Decree 91/2016/ND-CP issued 01/07/2016 regarding the management of insecticidal and germicidal chemicals and preparations for household and medical use.
The registrant should be aware of and comply with appropriate regulations. Any incorrect application will be revoked by the local department of Health.

2020-05-01T06:04:11+08:00 March 29th, 2020|Insight, Medical Regulation Updates, News & Events|

The Philippines Food and Drug Advisory (FDA) Advisory 2020-420: Procedures for FDA Clearance of Personal Protective Equipment (PPE) Prior to Customs Release

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Due to the rapid spread of COVID-19 in the Philippines, specific measures have been adopted for the expedient release of certain PPE such as face masks, shoe covers, gloves, head covers and gowns.

In response to the limited supply of PPE in the Philippines, the FDA has issued advisory 2020-420 on March 20, 2020 outlining the procedures for FDA Clearance of imported PPE. Due to the rapid spread of COVID-19, the following measures are being adopted for the expedient release of certain PPE within the jurisdiction of the Bureau of Customs. The PPE includes:
1) Face masks including N95 masks
2) Shoe covers
3) Gloves
4) Head covers, and
5) Gowns

If the above-mentioned PPE is intended for entry to the local market for commercial use, the importer must provide two documents for customs release: a copy of the importer’s License to Operate (LTO) and proof of application for notification, such as an electronic acknowledgment.

For foreign donations of the same PPE to a company, clearance from the FDA is not necessary. This is in regard to companies with employees that use face masks in the performance of their jobs and are strictly for company use, but does not include medical device establishments.
These procedures for the clearance of PPE prior to customs release shall be in effect until otherwise lifted.

Guidance for Applications and Transactions at the FDA in Light of the Community Quarantine Declaration:

On March 17, 2020, the FDA issued Circular 2020-006 to notify all stakeholders as well as the general public of its interim changes in work arrangements and how applications will be accepted in light of the Covid-19 outbreak, specifically for a License to Operate (LTO), Certificate of Product Registration (CPR) and Certificate of Product Notification (CPN). These guidelines are listed below:

A. License to Operate (LTO)
1.) Initial Application
– Initial LTO application will still be processed online through the FDA ePortal System. However, high priority will be given to establishments with functions intended for use in the diagnosis, cure, mitigation, treatment, prevention of Covid-19, as well as those that provide PPE and essential medicines.
– Initial LTO applications from manufacturers of health products must await a pre-license inspection schedule which will be released as soon as the community quarantine in Luzon and/or the respective Local Government Unit of the establishment is lifted. Foreign good manufacturing process (GMP) inspection shall also be postponed due to the the same circumstances. Exception to this shall be given to establishments that provide health products intended for use in the diagnosis, cure, mitigation, treatment, prevention, and provision of PPE for Covid-19, in addition to essential medicines.

2.) Renewal Application
– All LTO Renewal applications received from March 1- May 31, 2020 shall be given automatic extension of validity for another four (4) months after the expiration date of the LTO by virtue of the FDA Circular.
– All expiring LTO must still apply for their renewal using the FDA ePortal System. Failure to apply before its expiration date shall be subject to existing FDA rules and regulations
– For transactions with the Bureau of Customs (BOC), please provide this Circular as an attachment in support of the expired LTO.

B. Certificate of Product Registration (CPR) / Certificate of Product Notification (CPN)
1. Initial Application
– Initial CPR & CPN applications will still be processed online through the FDA ePortal System, as applicable; however, high priority will be given to health products intended for use in the diagnosis, cure, mitigation, treatment, prevention, and personal protective equipment (PPE) of Covid-19, and essential medicines.

2. Renewal Application
– All CPR & CPN applications received from March 1- May 31, 2020 shall be given an automatic extension of validity for another four (4) months after the expiration date of the CPR or CPN.
– For transactions with the BOC, please provide this Circular as an attachment in support of the expired CPR or CPN.

Specific instructions for stakeholders of the Center for Device Regulation, Radiation, Health and Research (CDRRHR) and the Food and Drug Action Center (FDAC) in relation to medical devices are provided below.

A.) CDRRHR applications

The following applications are hereby suspended for application until further notice:
1.) Initial application of LTO for Radiation Facilities
2.) Application for Radio Frequency Radiation Desktop Evaluation
3.) Initial application of CPR for medical devices, in-vitro diagnostic devices, water purification systems and healthcare waste systems
4.) Applications for variations of CPRs for medical devices and in-vitro diagnostic devices
5.) All letters, follow-ups and technical enquiries shall be sent to the respective Center

B.) FDAC Transactions
1.) The FDAC shall be automatically relocated in skeletal workforce to the FDA central office from Mondays-Fridays between the hours of 9:00 am- 4:00 pm.
2.) Status of applications may still be viewed via the FDA website Document Tracking Status and respective e-Portal accounts. Provide the Case number and/or Document Tracking Number (DTN) of your application to review the tracking status.
3.) All letters, follow-ups, and technical enquiries shall be sent to respective Centers via the email addresses
FDAC- fdac@fda.gov.ph
CDRRHR- cdrrhr@fda.gov.ph
4.) For the CDRRHR, the following applications will be accepted:
COVID-related test kits following Memorandum No 2020-006 dated March 12 entitled ‘Issuance of Special Certification for Imported Test kits of COVID-19’
Compassionate Special Permit
The circular order shall take effect immediately and until further notice.

FDA issues Memorandum 2020-006 pertaining to the issuance of special certification for imported test kits of COVID-19

With the expanding global outbreak of respiratory illness caused by COVID-19, the CDRRHR shall be issuing a special certificate for imported in-vitro diagnostic (IVD) kits used for diagnosis and screening of COVID-19. The following are the requirements:
1.) Letter of intent regarding exemption of the device/product from registration
2.) Valid License to Operate as a Medical Device Importer/Distributor/Exporter
3.) Fee of Php 510.00
4.) Product registration issued by the regulatory agency or their accredited third party from the countries with established regulation such as, but not limited to, the US FDA, Therapeutic Goods Authority, European Union, Health Science Authority, Pharmaceutical and Medical Device Authority, Ministry of Food and Drug Safety (Korea), and Health Canada; or WHO pre-qualified or EUL.

2020-03-31T16:29:47+08:00 March 29th, 2020|Insight, Medical Regulation Updates, News & Events|

COVID-19 update from Andaman Medical

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Some health ministries in the ASEAN region have shut down their operations to help mitigate the spread of COVID-19; therefore, it is likely that there will be a delay in the processing of medical device registrations over the coming months. We are monitoring the situation closely as it evolves and continue to operate as usual; however, some delays are to be expected..

Dear partners,

As you will no doubt be aware, the novel coronavirus (COVID-19) pandemic continues to have an impact around the world.

As a direct result, some health ministries in the ASEAN region have shut down their operations to help mitigate the spread of COVID-19; therefore, it is likely that there will be a delay in the assessment and processing of medical device and in-vitro diagnostic product registration applications over the coming months. At Andaman Medical, we are monitoring the situation closely as it evolves and continue to operate as usual; however, some delays are to be expected.

In line with local health advice and to ensure the safety and health of our staff, we have also implemented a working-from-home policy for the coming weeks. Please rest assured that all staff members have the tools they need to be able to work efficiently from home. In addition, all internal and external meetings can now be conducted via our new video conferencing system.

We would like to take this opportunity to offer you our support during these challenging times. Should you have any queries regarding regulatory requirements in the ASEAN region, please do not hesitate to get in contact with our team at contact@andamanmed.com

Thank you and stay safe!

2020-03-20T20:35:55+08:00 March 20th, 2020|Event, News & Events|