Special Access Routes in Indonesia and the Philippines – live webinar

OSCAR system

Join us for the second webinar in our series “Medical Device Regulatory Special Access Routes”. After having taken an indepth look at Malaysia and Singapore in the first webinar, this time we will be focussing on Indonesia and the Philippines. Register today!

Register today for our live webinar on Medical Device Regulatory Special Access Routes for Indonesia and the Philippines

This webinar is the second in a series on ASEAN markets. This webinar has been created to provide you with a clearer picture on how to navigate the expedited access pathways to register, import and distribute medical devices during the COVID-19 outbreak and beyond.

In this webinar, you will gain knowledge of the following:
– Overview of current situation in Indonesia and the Philippines
– What are the Special Access Routes (SAR) available versus standard registration?
– Which medical devices are included in Special Access Routes?
– Who can import?
– Overview of the Special Access Routesprocedures
– Timeframes to market
– Distribution routes for your medical devices
– Question and Answer session

Our presenters:
– Femilia Aulina, Regulatory Affairs Specialist, Indonesia
– Melody Quebec, Regulatory Affairs Specialist, Philippines

Register today! 

This second edition follows on from our highly successful first webinar which was held live on Tuesday 21st April 2020 and covered the Special Access Routes for medical devices in both Malaysia and Singapore. Some comments from participants:

“I would like to congratulate you for the success of the webinar. Well done guy and gals.  It really helps our company to make subsequent marketing development plan amid this crisis.” 

“Thank you Andaman for organising a very useful session for SAR into Singapore and Malaysia”. 

We will be hosting a final live webinar covering the same topic for Thailand and Vietnam later in May 2020. You can request the webinar recording for Malaysia and Singapore as well as request to sign up in advance for the final webinar on Thailand and Vietnam by emailing victoria@andamanmed.com 

And don’t forget that we also offer personalised training as well as online training courses . Send us an email us to find out more.

2020-04-30T18:38:55+08:00 April 30th, 2020|Event, Insight, Medical Regulation Updates, News & Events|

Cargo Targeting System guidelines now available for the Philippines

OSCAR system

The Philippines’ Bureau of Customs (BOC) has issued operational guidelines for foreign carriers and their authorized agents on the submission of the advance cargo declaration and manifest to the Cargo Targeting System (CTS).

The Philippines’ Bureau of Customs (BOC) has issued operational guidelines for foreign carriers and their authorized agents on the submission of the advance cargo declaration and manifest to the Cargo Targeting System (CTS).

The BOC launched the Cargo Targeting System which is a World Customs Organization (WCO) enterprise solution last year. This was regulated for under the Customs Memorandum Order (CMO) No. 48-2019, signed on October 22, 2019.

The CTS complements the BOC’s risk management system and beefs up their intelligence system in identifying and preventing fraudulent practices, especially for regulated shipments. The system will make the processing of shipments more efficient and will greatly improve the profiling, risk assessment, anti-terrorism, law enforcement and trade facilitation initiatives of BOC. For example, the online system allows shipping lines to submit manifests in advance.

Submitting an advance manifest is a requirement under the Customs Modernization and Tariff Act (CMTA) and is part of BOC’s 10-Point Priority Program designed to boost trade efficiency while ensuring border security.

The new Customs Memorandum Order (CMO 48-2019) which covers the CTS applies to the following categories whose cargoes, including transshipments, are destined for the Philippines:

  • airlines
  • shipping lines/shipping agents
  • non-vessel operating common carriers
  • freight forwarders/cargo consolidators/co-loaders

When to submit the cargo manifest according to CMO 48-2019:

  • For sea freight carrier should submit the cargo manifest electronically at least 24 hours before the vessel arrives.
  • For air freight, submission should be at least one hour before the aircraft arrives if the port of origin is in Asia, and at least four hours before it arrives if the port of origin is other than Asia.

Rules on the electronic cargo manifest/consolidated cargo manifest (CCM):

  • It should be submitted to the CTS in XML format or in any other format prescribed by BOC.
  • The carrier should use BOC-accredited value-added service providers (VASPs) or accredited information processors for the submission of an Inward Foreign Manifest (IFM) or a Consolidated Cargo Manifest (CCM) to the CTS and to E2M (electronic to mobile) system.
  • The cargo description in the cargo manifest must be precise enough to enable BOC to identify goods for discharge at the port and take pre-emptive action, if warranted.
  • Generic descriptions in the cargo manifest of the carrying vessel such as FAK (Freight All Kinds), general cargo and/or similar terminologies will not be allowed and will be considered as failure to exhibit the required document. Only the master bill of lading (B/L) or master air waybill (AWB) are allowed to use cargo description such as “consolidated Balikbayan box” for freight forwarders handling balikbayan boxes only, or “consolidated cargo” for freight forwarders handling non-balikbayan boxes.

Penalties for failure to comply

Under Section 1412 of the CMTA, failure to transmit the electronic manifest within the required time will make the owner, operator, or agent of the vessel or aircraft liable for a fine of not less than P100,000 but not more than P300,000. If the transit time from port of origin to port of entry is at least 72 hours, the shipping or forwarding agent of the carrier or the vessel that fails to submit the manifest at least 24 hours before entry will likewise be liable for a fine of not less than P100,000 but not more than P300,000.

About the WCO CTS:

The CTS helps identify high risk shipments and facilitates trade. It allows WCO member-countries to adopt international best practice in cargo risk assessment. And it implements key parts of the WCO’s SAFE framework to secure and facilitate global trade. Click here for information on the CTS in the Philippines.

For more information on our services in the Philippines or if you’d like help with the customs declarations in the Philippines please contact Andaman Medical.

2020-04-30T18:38:43+08:00 April 30th, 2020|Insight, Medical Regulation Updates, News & Events|

Import procedures simplified for COVID-19 in Indonesia

OSCAR system

Indonesia’s Health Ministry has simplified import procedures to make it easier to import medical equipment for the purpose of helping the Covid-19 outbreak. Previously, imports of medical equipment had to have an import permit in the form of a distribution permit or Special Access Scheme (SAS) permit from the Health Ministry. Now, importers need to obtain a permit exemption recommendation from the National Disaster Mitigation Agency (BNPB).

Indonesia’s Health Ministry has simplified import procedures to make it easier to import medical equipment for the purpose of helping the Covid-19 outbreak. Previously, imports of medical equipment had to have an import permit in the form of a distribution permit or Special Access Scheme (SAS) permit from the Health Ministry. Now, importers need to obtain a permit exemption recommendation from the National Disaster Mitigation Agency (BNPB).

Medical devices, in vitro diagnostic medical devices, and household health supplies used for Covid-19 have been given relaxation, which means they do not require a distribution permit or SAS. This is legislated for by the following regulations issued by the Ministry of Health: Regulation number 7, year 2020, and Decree number HK.01.07, year 2020.

To request a permit exemption recommendation from the National Disaster Mitigation Agency (BNPB), importers should use the Indonesia National Single Window website. After completing an application form and uploading the required documents, applicants will be able to track the status of their application. Once reviewed applicants will be notified of rejection or approval (the permit exemption recommendation). And depending upon the type of import, commercial or non-commercial, there are different import procedures to follow:

For non-commercial imports:

  • importers should submit the permit exemption recommendation to the Customs Office
  • the Customs Office will process the request by issuing a Finance Ministry letter (SKMK) for customs, excise and import tax exemption
  • importers then submit the SKMK together with the BNPB permit recommendation to the Customs Office for an import declaration (PIB)
  • customs clearance will be given once all requirements are satisfied

For commercial imports:

  • Importers can request the import declaration letter directly by submitting the details of the BNPB permit exemption recommendation.
  • They will receive customs clearance once their application is approved.

For more information on our services in Indonesia or if you’d like help with the import procedures during the COVID19 outbreak in Indonesia please contact Andaman Medical.

2020-04-30T18:38:05+08:00 April 30th, 2020|Insight, Medical Regulation Updates, News & Events|

New OSCAR system for corrective action reporting in Singapore

OSCAR system

The Health Science Authority (HSA) in Singapore launched the new OSCAR system for Field Safety Corrective Action (FSCA) reporting online earlier this year. Previously the HSA accepted the reporting and monitoring of FSCAs via email. However, as of 6 April 2020 companies must use the OSCAR system.

The Health Science Authority (HSA) in Singapore launched the new OSCAR system for Field Safety Corrective Action (FSCA) reporting online earlier this year. Previously the HSA accepted the reporting and monitoring of FSCAs via email. However, as of 6 April 2020 companies must use the OSCAR system.  To do so companies require a Corppass Account to access the OSCAR system. Corppass account administrators can create several profiles for company users and grant them relevant accesses. Upon the first login the company details are imported into the OSCAR System making it more convenient to use.

There are two main types of FSCA reporting in Singapore:

  1. When the affected devices are manufactured or supplied in Singapore. In this case a Notification Report (MDRR1 form) should be submitted to HSA via OSCAR. After initiating the FSCA, a Final Report (MDRR2 form) needs to be submitted within 21 days to the authority. If the FSCA has not been completed, a follow-up report needs to be submitted at the 21st day mark. The content of the forms can be found in the online OSCAR system for easier submission.
  2. For affected medical devices that are registered via the Special Access Route (SAR) clearance but have not yet been supplied in Singapore. A MDRR3 form to report FSCAs should be performed via OSCAR within 30 days of initiating an FSCA in any country globally.

Companies should not delay a FSCA notification due to incomplete information such as distribution information, batch size etc which understandably takes longer to prepare. Once an FSCA notification report is submitted and received by the HSA, an acknowledgement is issued to the reporting person. In the acknowledgement, the HSA will inform the reporting person on the actions to be taken. The various actions that could be instructed include recall, labelling changes, supply of CIP (correction in progress medical devices) and cease of supply.

The OSCAR system was officially launched on 6th January 2020 so that Medical Device Dealers could begin submitting FSCA reports to HSA via the online platform. All dealers had a transitional period of 3 months (6 January 2020 to 5 April 2020). However, following full implementation on 6 April 2020, the HSA now only accepts online FSCA report submission via OSCAR.

For more information on our services in Singapore or if you’d like help with the OSCAR system in Singapore please contact Andaman Medical.

2020-04-30T18:37:29+08:00 April 30th, 2020|Insight, Medical Regulation Updates, News & Events|

Orphaned medical devices guidance for Malaysia

Orphaned medical devices

Earlier this year the Medical Device Authority (MDA) in Malaysia released a guidance document on actions for Orphaned Medical Devices. The guidance instructs companies on what to do in the case of orphaned, obsolete and discontinued medical devices in hospitals or healthcare related facilities.

A “Notification for Orphaned Medical Devices” guidance document was issued on 18 February 2020 by the Medical Device Authority (MDA) in Malaysia. This guidance relates to the Circular Letter of Medical Device Authority No. 2 Year 2018, “Control of orphaned, obsolete and discontinued medical device in hospital or healthcare and related facilities”.

An orphaned medical device is an existing medical device in a hospital, healthcare facilities, or related facilities that is not registered under Medical Device Act 737 as it no longer has the manufacturer or authorized representative to register the medical device or the manufacturer or authorized representative has ceased operation.

You must submit a notification of listing to the MDA by using the “Notification Listing of Orphaned Medical Device Form” (which can be found in Annex A of the guidance document). You can send the form by email to the Chief Executive of the Medical Device Authority at email address ood.md@mda.gov.my . Each notification submitted can be used for more than one medical device or location. The MDA will issue a notification (approval) letter once your application has been approved. The processing timeline for the notification letter is 21 working days. You must not use the approval letter for promoting or advertising the device.

Please note that the orphaned medical device shall not be sold, loaned, provided for free, donated or used in research on humans. An orphaned medical device may be used for teaching/education purposes, but it must not be used on patients. The MDA shall be informed of any change in location of this device. It may be sold to a third party for the purpose of disposal only. When the medical device is no longer safe and effective, it shall be removed and disposed of in a safe manner and the MDA shall be notified as in Annex B. The full guidance document can be found here.

For more information on our services in Malaysia or if you’d like help with orphaned medical devices in Malaysia please contact Andaman Medical.

2020-04-30T18:36:55+08:00 April 30th, 2020|Insight, Medical Regulation Updates, News & Events|