Vietnam produced SARS-CoV-2 Test Kit and Regulation for the Importation of Test Kits during the pandemic

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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.

2020-04-02T12:05:53+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.

2020-03-31T17:19:06+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|

Overview of the e-Catalogue in Indonesia

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The use of the e-Catalogue in Indonesia makes the procurement of goods/services in the public sector more efficient. Shorter procurement times and fair competition partners ensure the government is getting the best price.

The Electronic Catalogue (e-Catalogue) is an electronic information system that lists the technical specifications and prices of certain goods and services from various providers. The e-Catalogue was created by the Government Goods/Services Procurement Policy Agency, Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah (LKPP), at the end of 2012.

Some of the benefits of using the e-Catalogue are:

  1. It makes the process of procurement of goods/services in the public sector more efficient. Shorter procurement times and competition partners ensure the government is getting the best price.
  2. The e-Catalogue also increases transparency. This can supress the problem of budget leakage that often occurs in the procurement of goods/services.
  3. It simplifies the process, making it more inviting for partners to participate.

An e-Catalogue of medical devices has been promoted since 2015. The next opening date for procurement of the medical devices e-catalogue is yet to be announced. The LKPP will announce it on their website (http://lkpp.go.id).

Once announced, the LKPP will aim to inform all those medical device distributors who may want to join the e-Catalogue. LKPP will then issue an invitation to all registered companies to meet. At the meeting, the LKPP will explain the procedures for the opening bid schedule and any requirements. All information shared by the LKPP will be available in the bid document. This is normally shared on the LKPP website and can be downloaded.

Documentation required by the LKPP:
1. Offering Letter
2. Qualification Form
– Deed of establishment
– Latest amendment to the deed of establishment (if any)
– Business License Number (NIB)
– Tax ID number
– Latest annual tax notification (typically LKPP will mention the latest year that can be used)
– Medical Device Distribution Certificate (referred to as IPAK)
– Letter of Authorization with Principle/Manufacturer
3. Integrity Pact
4. Technical Bid Documents
– Technical specification of the product
– Statement letter of product warranty (at least one year).
– Statement letter of guaranteed availability of spare parts for at least 5 years.
– Registration Certificate issued by Ministry of Trade (referred to as Surat Tanda Pendaftaran or STP)
– Approval License issued by Ministry of Health
5. Bidding Documents
– A price list of government and non-government offers for each product
– Bid price in Indonesian Rupiah (IDR)
– Imported products must include the most recent Goods Import Declaration (called the PIB) and the item purchase invoice.

The LKPP values those bids that provide:
1. Evaluation and proof of qualifications
2. Administrative evaluation
3. Technical evaluation
4. Negotiation

The LKPP will seek further clarification from those who have submitted all the required documentation. They will also check copy documents against the original hardcopy. If complete and eligible, the LKPP will invite eligible producers into a negotiation on product price.

The LKPP will issue a contract of catalogue to those successful in negotiations. This is a co-operation agreement signed by the LKPP and the provider for inclusion of goods/services in an e-Catalogue for two years. After receiving the contract of catalogue, providers can submit the agreed upon product into the e-catalogue system: http://e-katalog.lkpp.go.id/

2020-03-02T03:26:18+08:00 February 27th, 2020|Event, Insight, News & Events|

Vietnam: Import Duty Exemption for Selected Medical Devices Amid COVID-19 Outbreak

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The Ministry of Finance have assigned the General Department of Customs to direct and guide customs units to implement the tax exemption policy for imported goods in order to prevent and control the Covid-19 epidemic.

The Minister of Finance, Mr. Dinh Tien Dung, has announced a tax exemption on imports of five commodity groups that are needed to fight the novel coronavirus. On February 7th 2020, authorities signed Decision 155/QĐ-BTC allowing import tax exemptions on medical masks, hand sanitizer, mask materials, disinfectant and protective clothing.

The Ministry of Finance (MoF) has assigned the General Department of Customs to direct and guide customs units to implement the tax exemption policy for imported goods to prevent and control the epidemic. Customs offices will carry out customs clearance for goods in the groups and will also work with relevant agencies to inspect and ensure importation is for the correct purposes.

The groups of goods subject to exemption include:
– Medical masks with international harmonized system (HS) codes* of 6307.90.40 and 6307.90.90.
– Disinfectant gel or liquid hand sanitizer with HS code 3808.94.90.
– Mask materials include non-woven fabrics and antibacterial filters; elastic bands with the regulated HS codes.
– Disinfectants with HS codes of 3808.94.20 and 3808.94.90.
– Protective clothing including trousers, shirts, goggles, medical masks, helmets, gloves and shoes with HS code 6210.10.90.

This decision took effect from February 7th 2020 until the end of the epidemic.
*HS code stands for the Harmonized System code describing the type of goods

2020-03-02T03:29:16+08:00 February 26th, 2020|Event, Insight, News & Events|

Philippines: Custom’s New Alert Order Monitoring System

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The written alert order form will serve as the notice of alert to the recipient offices prompting them to take appropriate action. Alert orders may be provisionally lifted if the district collector orders the examination of goods on the consignee’s premises or in examination areas approved by the Bureau of Customs.

The Bureau of Custom’s (BOC) new alert order monitoring system (AOMS) is now operational. Customs Memorandum Order (CMO) No. 47-2019 was dated and signed on September 11 2019 by Customs commissioner, Rey Leonardo Guerrero. This implements Customs Administrative Order (CAO) No. 07-2019, CMOs 19-2018 and 6-2019, and other BOC rules covering alert orders. The AOMS will be used by the Alert Order Clearing House Desk (AOCHD)—the central clearing house created through CAO 07-2019—to monitor alert orders issued by various authorized officers of BOC.

An alert order is a written order issued by the customs commissioner, the district collector, or other customs officers authorized in writing by the commissioner, after the goods declaration is lodged and before the goods are released from customs custody. Under CAO 07-2019, the alert order can be issued upon critical information regarding possible non-compliance with the Customs Modernization and Tariff Act and other laws, rules and regulations enforced by BOC.
Once issued by the alerting authority, the written alert order form should be forwarded within an hour to the relevant port’s Formal Entry Division, the Office of the Deputy Collector for Operations, the District Enforcement and Security Service, the District Customs Intelligence and Investigation Service, the District Customs Anti-illegal Drugs Task Force, and the X-ray Inspection Project field office.

The written alert order form will serve as the notice of alert to the recipient offices, causing them to take prompt and appropriate action. Alert orders may be provisionally lifted if the district collector orders the examination of goods on the consignee’s premises or in examination areas approved by BOC. The district collector may also allow transfer of the alerted goods for examination in certain circumstances, such as perishable goods, and goods that could be easily damaged during examination.

Other cases for provisionally lifting alert orders include the following:
-The receiving operator does not have the equipment or facility to perform an examination
-The examination at the consignee’s premises or warehouse is a privileged area, protected under law or existing rules and regulations
-The containers have been subjected to initial 10% physical examination and there were no adverse findings
-Other instances as may be approved by the district collector or port collector.

If the AOMS cannot be accessed, the concerned offices should implement interim manual procedures that will minimize disruption to the processing of alert orders. Once AOMS access is restored, documents and transactions processed manually should be added to the AOMS, (as per CMO 47-2019). Physical examination or non-intrusive inspection should be made within 48 hours of receipt of the alert order or pre-lodgement control order (PLCO) by the district collector’s office. Exceptions apply in cases where elements are beyond their control, such as, but not limited to, the unavailability of equipment required for examination, force majeure (removing liability for natural disaster), or other fortuitous event.

A PLCO is a written order (under CAO 07-2019 ) issued by the Customs commissioner, the district collector, or other customs officers (must be authorized in writing by the commissioner), before the goods declaration is lodged or when no goods declaration is lodged. This is to prevent the illegal importation or their release. BOC personnel found to have violated the provisions of CMO 47-2019 will face the “appropriate civil and/or criminal liability and any administrative sanctions that may be imposed by the BOC.”

2020-03-02T03:32:18+08:00 February 26th, 2020|Insight, Medical Regulation Updates, News & Events|

Indonesia: Purpose of GDPMD and its Implementation

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Good Distribution Practice of Medical Devices, which will be referred to here as CDAKB, is a guideline used in a series of distribution and quality control activities aimed at ensuring that distributed medical device products meet the requirements of their intended use.

Medical devices are different from ordinary commodities. They are an industrial product with distribution requirements to ensure that safety, quality and functionality can be guaranteed.

Improper handling during distribution activities can negatively impact upon the safety, quality, and benefits of medical devices. Distributors of medical devices in Indonesia(PAK) have an important role in ensuring the safety, quality, and benefits of medical devices.

In order to guarantee safe, quality and functional medical devices, the distribution system must comply with the Guidelines for the Distribution of Good Medical Devices issued by the government as specified in PERMENKES No. 4 of 2014.

Good Distribution Practice of Medical Devices, referred to as CDAKB, is a guideline for distribution and quality control activities. The aim of this guideline is to ensure distributed medical device products meet the requirements of their intended use.

Purpose and Benefits of the Application of CDAKB
1. Quality
The process of continual improvement to maintain the quality of distributed medical products
2. Management System
Application of Management System in the distribution process
3. Regulation
Compliance with state regulations.

According to the MoH in Indonesia, there is a possibility that every distributor who deals with medical devices will need to implement CDAKB as a mandatory requirement in 2021. This is yet to be confirmed. The application of CDAKB can ensure safe, quality and functional medical devices that meet the needs of the community while also maintaining patient safety.

2020-03-02T03:35:34+08:00 February 26th, 2020|Insight, Medical Regulation Updates, News & Events|

COVID-19 Impact on the Medical Industry and Measures by Health Science Authority, Singapore

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In order to deal with the current ‘’out of stock’’ and overly inflated prices of surgical masks, hand sanitisers, respirators, thermometers and protective gear due to the COVID-19 outbreak, the HSA in Singapore has put measures in place by restricting import of these ‘’high in demand commodities’’

In recent times, one of the most talked about topics in the world is the rise of the novel coronavirus strain, officially named COVID-19. The virus is severely contagious and is having a worldwide impact.

It is not easy to miss the snaking queues at pharmacies for surgical masks, sanitisers, protective clothing and pretty much anything else that claims to have antiseptic & antibacterial properties. Pharmaceutical companies are also making a lot more money by selling immune boosting supplements and flu medications. People are being overly conscious and cautious with flu like symptoms, especially in those countries with a greater presence of positive COVID-19 cases.

Medical device companies are experiencing increased sales by catering to the need for diagnostic kits, protective clothing, gloves, testing equipment, x-ray machines etc. Although the medical and pharmaceutical device industries are experiencing increased sales, they are also providing funds for research into the cure and treatment of the virus.

In order to deal with the current ‘’out of stock’’ labels and overly inflated prices of surgical masks, hand sanitisers, respirators, thermometers and protective gear, the HSA has put measures in place by restricting the import of these ‘’high demand commodities’’ for personal use beyond certain quantities. In an attempt to tackle the risk of substandard products in the Singapore market, they have also implemented easier importation options for dealers by forgoing the need for an ‘’Importer’s License by the HSA’’. During this time, importers only need to notify an intention to import to the authority. They also need to provide information regarding the brand and quantity of devices that are to be imported into Singapore. It is expected that they maintain proper sales and distribution records. These records will later be subject to submission to the HSA.

2020-03-02T03:37:50+08:00 February 26th, 2020|Event, Insight, News & Events|