Medical Device Advertising Regulation in Malaysia – transitional period

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On 20 May 2020, the Medical Device Authority (MDA) in Malaysia, released its first circular letter of the year, stating that there will be a transitional period for the enactment of the Medical Device (Advertising) Regulation 2019. This regulation was due to come into full effect on 1st July 2020. However, due to some implementation issues that require more time to be resolved, the implementation date has been extended to 31st December 2021.

As a reminder: the Malaysian Federal Government released a regulation related to the advertisement of medical devices in Malaysia back in November 2019. According to the Medical Device (Advertising) Regulation 2019, no person shall advertise any registered medical device without the approval from the Authority. Any person who commits an offence, shall, upon conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding two years, or to both.

The Medical Device (Advertising) Regulation 2019 also states that applications for approval for an advertisement shall be submitted in writing to the MDA along with a copy of the proposed advertisement, the processing fee of one thousand ringgit (approx. 235 US Dollars) and a letter of appointment from the establishment whose medical device is being advertised if applicable. Each advertisement must include the registration number assigned by the MDA to the said medical device.

However, the decision of the MDA to introduce a transitional period of 18 months (commencing from 1st July 2020 until 31st December 2021) for the implementation of Medical Device (Advertising) Regulation 2019, will now allow the MDA together with the medical device industry to specify details on its implementation.

This circular letter was issued under Medical Device Act 737 and is effective from the date of issue. Click here to read the full circular letter on the transitional period for medical device advertising in Malaysia.

If you have any queries regarding the transitional period for medical device advertising or our services for medical device registration and representation in Malaysia, please contact us at contact@andamanmed.com.

2020-06-10T17:23:21+08:00 June 10th, 2020|Insight, Medical Regulation Updates, News & Events|

Medical device distribution records in Malaysia

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Back in November 2019, the Malaysian Federal Government released legislation pertaining to the duties and obligations of medical device establishments in Malaysia. The regulation highlighted the information required to be collected and stored by establishments, such as distribution records, records of complaint handling, mandatory problem reporting, field corrective or preventive action, voluntary recall, and mandatory recall. This regulation shall come into operation on 1 July 2020.

Specifically, as regards to medical device distribution records, the Medical Device Authority (MDA) released a guidance document, MDA/GD/0008, on 4 June 2020 in advance of the requirements coming into effect on 1 July 2020. This ensures that medical devices placed on the market meet appropriate standards of safety, quality, performance and effectiveness and that medical devices are used safely by the public.

Distribution records shall contain the following information:

  1. Postal address of the consignee(s) in a format that allows physical location to be established together with a telephone number;
  2. Address of the place of storage of the medical device;
  3. Identification of a medical device(s); make, class, model number or item description, part number, batch number, and quantity of the devices, including any medical device that is part of a medical device grouping as prescribed in Part II, Second Schedule of Medical Device Regulations 2012 (if applicable);
  4. Details of the delivery and receipt of the medical device which are traceable to all shipping/delivery documentation information;
  5. Information and documentation on the disposal of the medical device (if applicable); and
  6. Any other information as may be required by the Authority.

For implantable medical device, the distribution records shall contain additional information as follows:

  1. Details of the healthcare facility where the implantable medical device is implanted including the department which conducts the implantation procedure;
  2. Details of the patient on whom the implantable medical device is implanted or used if possible, to get the information;
  3. Date of implantation of the medical device; and
  4. Details of removal of the implantable medical device, if applicable

Distributors and importers in Malaysia, including exporters dealing with the medical devices, shall have correctly documented information in the distribution records. Distribution records shall be retained as follows:

  1. For 2 years after the date on which the medical device is supplied;
  2. If the medical device is for export, for 2 years from the date the medical device is shipped out of Malaysia; or
  3. If the medical device has a projected useful life, for the projected useful life of the medical device as determined by the manufacturer, whichever period is longer.

For implantable medical devices such as pacemakers, defibrillators, and drug infusion systems, establishment shall track all implantable medical device down to patient level in the case of any incident relating to the implantable medical device, FCA, or recall is required to be conducted. If tracking is not possible at the patient level, the establishment shall track the implantable medical device down to the healthcare facility level or keep track of the date of the medical device being put into service or implanted into a patient.

Click here to read the full guidance document on medical device distribution records in Malaysia.

If you have any queries regarding the medical device distribution records or our services for medical device registration and representation in Malaysia, please contact us at contact@andamanmed.com.

2020-06-08T18:37:41+08:00 June 8th, 2020|Insight, Medical Regulation Updates, News & Events|

Importation and manufacture of PPE, respirators and ventilators

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Updated guidance on the importation and manufacture of PPE, respirators and ventilators was issued on 26 May 2020 by the Philippines’ Food and Drug Administration (FDA) in Circular 2020-018 which repeals FDA Advisory Nos. 2020-547 and 2020-449 which legislated for Special Access Routes for the their importation and manufacture to help respond to the COVID-19 outbreak.

The Philippines government now considers that there is adequate supply of these essential medical devices. And as a consequence, the increased supply is leading to concerns over the safety and quality of these medical devices used during the pandemic.

The guidance issued in this Circular No. 2020-018 states updated licensing and registration requirements and customs release procedures for the importation and manufacture of PPE, respirators, and ventilators:

Importation or manufacture of PPE

All establishments which intend to import or manufacture of PPE must first obtain a License to Operate as a medical device importer or manufacturer and then they should apply for a Certificate of Product Notification (CPN) before placing the medical devices on the market.

Importation or manufacture of respirators & ventilators

All establishments which intend to import or manufacture respirators or ventilators must first obtain a License to Operate as a medical device importer or manufacturer and then they should apply for a Certificate of Product Registration (CPR) within 3 months after the lifting of State of Public Health Emergency (Proclamation NO 922 s. 2020).

Special note to those establishments who have started the importation or manufacture of PPE, respirators or ventilators under Advisory Nos. 2020-547 and 2020-449

Authorised establishments who have already started to sell and distribute their medical devices without product notification (CPN) or product registration (CPR) pursuant to Advisory Nos. 2020-547 and 2020-449 must apply for a Certificate of Medical Device Notification (CMDN) or a Certificate of Product Registration (CPR) before the 25th August 2020 (three months of the issuance date of Circular No. 2020-018). Non-compliance with this requirement will result in enforceable actions as necessary.

Customs release procedure for PPE, respirators and ventilators

All establishments who wish to import in order to commercialise PPE, respirators or ventilators need to present the importer’s License to Operate to obtain customs release. Whereas foreign donations of these particular medical device do not require this.

General guidance applying to medical devices used in the COVID-19 pandemic

All medical devices for use in the COVID-19 pandemic must adhere to the following guidance and standards as issued by the Philippines FDA regarding the development, design, clinical trial, testing, validation, risk management, manufacture, sterilization (non-exhaustive list) wherever applicable:

  • Philippine National Standards (PNS)
  • Applicable International Standards (ISO or IEC) in absence of the PNS
  • Technical requirements for registration as legislated for under AO No. 2018-002 Guidelines Governing the Issuance of the Authorization for a Medical Device based on ASEAN Harmonized Technical Requirements.

If you have any queries regarding the importation or manufacture of PPE, respirators or ventilators for COVID-19 or our services for medical device registration and representation in the Philippines, please contact us at contact@andamanmed.com.

2020-06-02T16:15:53+08:00 June 2nd, 2020|Insight, Medical Regulation Updates, News & Events|

Exportation of medical masks is now allowed in Vietnam

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The exportation of medical masks has now been authorized by the Vietnamese Government following the repeal by the Ministry of Health of the licensing ban. This is regulated for in the newly issued Government Resolution No.60/NQ-CP dated 29 April 2020. This means that the Government’s Resolution No. 20/NQ-CP dated 28 February 2020 on export licensing regulations are annulled.

With the new authorization of exportation of medical masks and the high demand for these items in many countries, the Vietnamese government simultaneously issued an official dispatch No.2507/BYT-TB-CT dated 07 May 2020 listing requirements for local companies who wish to begin the exportation medical masks (exporters) into foreign countries. And at the same time, the Vietnamese government has issued appropriate administration measures to ensure the adequate supply of medical masks for epidemic prevention and control in Vietnam.

Exporters shall be responsible for the quality of exported medical masks and guarantee to sell medical masks to local health facilities in Vietnam on demand.

To ensure the quality of medical masks, manufacturers must strictly comply to the following government instructions:

  1. The manufacturer of medical masks must be certified ISO 13485:2016 and that certificate has been issued by an establishment that has adopted Vietnam regulation Decree 107/2016 ND-CP dated 01 July 2016 for the provision of conformity assessment services. The list of published on website of Directorate for Standards, Metrology and Quality
  2. Medical masks must meet one of the following standards: TCVN 8389-1:2010, TCVN 8989-2:2010 or TCVN 8989-3:2010. Manufacturers for both domestic and export supply must provide the following additional documentation:
    • Manufacturer’s Declaration of Conformity,
    • Physicochemical parameters result of medical mask testing,
    • Declaration of eligibility to produce medical equipment,
    • Product license class A for medical masks.
  3. For those manufacturers who wish to export, the exporters should fully understand requirements and standards set by importing countries, to avoid any issues concerning quality and to avoid any refusal to import and the subsequent return of goods.

If you have any queries regarding the exportation of medical masks from Vietnam or our services for medical device registration and representation in Vietnam, please contact us at contact@andamanmed.com.

2020-06-02T01:10:04+08:00 June 2nd, 2020|Insight, Medical Regulation Updates, News & Events|

3D printed medical devices in Singapore

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With some organisations considering the use of 3D printed medical devices to counteract the shortfall in availability of Personal Protection Equipment (PPE), accessories for respirators and other items such as nasopharyngeal swabs, the Health Sciences Authority (HSA) in Singapore has recently issued guidance specific to this situation.

The guidance on 3D printed medical devices covers regulatory controls, licensing, product registration and notification, post-market duties and obligations. The guidance also covers some key technical considerations for design, validation, labelling and expiration as well as manufacturing to ensure the quality, safety and effectiveness of medical devices created using 3D printing.

All medical devices created via 3D printing are likewise classified into four risk classes: Class A (lowest risk) to Class D (highest risk). Face shields and external prosthetics that are manufactured using 3D printing are typically classified as class A. Whereas ventilator tubes or breathing circuits would be classified as Class B. Medical devices that are implants will typically fall in Classes C and D.

All manufacturers or suppliers of 3D printed medical devices must hold the relevant dealer licence from the Health Sciences Authority. A Quality Management System (ISO 13485 or equivalent) must also be in place for the 3D printing of the medical device. However, this requirement is relaxed for healthcare institutions or facilities which create medical devices via 3D printing for use on their own patients as long as the medical device is not supplied outside of the said healthcare facility.

All 3D printed medical devices that are intended for commercialisation must be registered with the HSA before being placed on the market except for Class A. Class A medical devices created through 3D printingdo not require registration, however they do require notification to the HSA before being placed on the market.

More information on the Guidance can be found here. And if you have any queries regarding medical devices created using 3D printing for the Singapore market or our services for medical device registration and representation in Singapore, please contact us at contact@andamanmed.com.

2020-06-02T01:07:40+08:00 June 2nd, 2020|Insight, Medical Regulation Updates, News & Events|

Personal Protective Equipment in Indonesia

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Personal Protective Equipment (PPE) are indispensable medical devices as they required to protect health workers and medical practitioners handling patients who are suspected or confirmed as infected with COVID-19 or other such contagious viruses. As such the Indonesian Ministry of Health has issued a Standards book regarding Personal Protective Equipment in Indonesia.

Reflecting the importance of Personal Protective Equipment in Indonesia, the Indonesian Ministry of Health (MoH) Directorate General of Pharmaceutical and Medical Devices has compiled a Personal Protective Equipment Standard Book in Management of Handling COVID-19. This standards book is expected to be a reference for manufacturers in producing Personal Protective Equipment in Indonesia. This book provides information about the different types of PPE used in handling COVID-19 such as:

  • Medical/Surgical mask,
  • Respirator N95,
  • Goggles,
  • Face Shield,
  • Examination Gloves,
  • Surgical Gloves,
  • Medical Coverall,
  • Heavy Duty Apron,
  • Waterproof Boots,
  • Shoe Cover.

The book also describes the specifications that must be met so that the PPE produced is safe, meets quality standards, and fits the purpose of use as Personal Protective Equipment in Indonesia. This PPE Standard Book can be downloaded here.

 Taking the example of Surgical Masks, the standards book states:

  • The use of surgical masks is to protect users from airborne particles, droplets, fluid viruses or bacteria
  • The frequency of use is single use
  • Material for manufacturing surgical masks should be Non-woven Spunbond Meltblown Spunbond (SMS) or Non-woven Spunbond Meltblown Meltblown Spunbond (SMMS)
  • Surgical masks are not recommended for direct management of patients confirmed by COVID-19.
  • The mask must withstand the penetration of fluids, blood, and droplets.
  • The inside and outside of the mask must be easily and clearly identified.
  • Mask should have loose fitting on the face
  • Masks must be designed so that they are not damaged by the wearer’s mouth
  • Has a 98% bacterial filtration efficiency.
  • The user can breathe well whilst wearing it (Differential Pressure/ΔP <5.0 mmH2O/cm2).
  • The mask has passed the following tests: Bacteria Filtration Efficiency in vitro (BFE), Particle Filtration Efficiency, Breathing Resistance, Splash Resistance, and Flammability tests.

If you have any queries regarding Personal Protective Equipment in Indonesia or our services for medical device registration and representation in Indonesia, please contact us at contact@andamanmed.com.

2020-06-02T01:06:39+08:00 June 2nd, 2020|Insight, Medical Regulation Updates, News & Events|

COVID-19 Antibody Test Kits online sales banned by Philippines FDA

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On 8 May 2020, the Philippines’ Food and Drug Administration issued Circular 2020-016 to remind all stakeholders (manufacturers, health facilities, and the general public) that the online selling of FDA Certified COVID-19 Antibody Test Kits is strictly prohibited.

This Circular complements prior Advisory notice no. 2020-497  to Market Authorization Holders (MAH) of COVID-19 antibody test kits (rapid test, point-of-care, lateral flow, Elisa, GICA, CLIA among others) that have obtained FDA special certification, that they are strictly for medical professional use and not intended for personal use, hence the reason for banning COVID-19 antibody test kits online sales.

The Circular also complements prior Advisory notice no. 2020-498 issued to inform the general public on the purchase and administration of all FDA certified COVID-19 antibody test kits. These products must be obtained on prescription from a licensed physician from licensed hospitals or drugstores/pharmacies/botica. Online sale is prohibited. The test must be administered by a doctor or a trained health professional. And interpretation of the result must be guided by a physician. The general public can report incidents regarding the improper dispensing and use of COVID-19 Rapid Antibody Test Kits by sending any relevant information such as the source, product name, importer/distributor to the following email address: covidresponse@fda.gov.ph.

Further to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, it is government policy to ensure the safety, efficacy and quality of IVD medical devices in the country in order to protect the health of the Filipino people. This means that all FDA Regional Field Offices and Regulatory Enforcement Units have been instructed to carry out exhaustive monitoring of all online platforms to ensure full compliance of this Circular undertaking enforcement actions as necessary.

If you have any queries regarding COVID-19 antibody test kits online sales or our services for medical device registration and representation in the Philippines, please contact us at contact@andamanmed.com.

2020-06-02T01:05:05+08:00 June 2nd, 2020|Insight, Medical Regulation Updates, News & Events|

Special Access Routes in Indonesia and the Philippines – live webinar

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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

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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

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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|