Marketing authorisation in Singapore: Allplex SARS-COV2 Assay

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Seegene Inc. has obtained provisional authorisation from the Health Sciences Authority (HSA) in Singapore for its Allplex™ SARS-CoV-2 Assay thanks to its ongoing partnership with Andaman Medical Pte Ltd, a regulatory affairs and market access consultancy specializing in South Asian markets for medical device and in-vitro diagnostics manufacturers.

In response to the COVID-19 outbreak Andaman Medical decided to offer its registration services free of charge for those products helping fight the pandemic that could be registered via Special Access Routes for both existing and new clients.

As an existing client since 2017, Seegene took up Andaman Medical’s COVID-19 special access route offer and is now happy to announce that it has secured Provisional Authorisation for Seegene’s Allplex™ SARS-CoV-2 Assay from the HSA in Singapore.

The Allplex™ SARS-CoV-2 Assay detects target genes specific to COVID-19 within a single tube and offers results in a short turnaround time of 1 hour and 50 minutes. This means patients can get accurate results and ultimately access to the appropriate treatment quickly.

Notes:

Background to the Seegene / Andaman Medical partnership.

Seegene first appointed Andaman Medical back in 2017 to register an initial product range of IVD test kits in Singapore and act as its local authorised representative in the market.

Relying on the expertise of Andaman Medical’s in-house Regulatory Affairs Specialist for Singapore, Mrs Jhelum Bandyopadhyay, Seegene recently expanded its portfolio of products for registration in Singapore to include other types of assays of varying risk class and now also includes its Allplex™ SARS-CoV-2 Assay.

About Seegene’s Allplex™ SARS-CoV-2 Assay

The Allplex™ SARS-CoV-2 Assay is an in vitro diagnostic medical device designed for qualitative detection of SARS-CoV-2 with real-time reverse transcription PCR from nasopharyngeal aspirate, nasopharyngeal swab, bronchoalveolar lavage, oropharyngeal (throat) swab, and sputum.

About Seegene Inc.

Seegene (KQ : 096530) is a global pioneer in symptom-based in vitro molecular diagnostics focusing on advancing science to develop multiplex molecular technologies and to manufacture multiplex in vitro diagnostic devices and reagents. Seegene’s core enabling power is the passion for wide spreading of multiplex molecular diagnostics to improve the quality of life and health of people. Using its innovative proprietary technologies, Seegene has been making considerable contributions to giving the most economic and clinic-friendly molecular diagnostic solutions for infectious diseases, genetics, pharmacogenetics, and oncology. For more information, please visit www.seegene.com.

About Andaman Medical Pte Ltd, Singapore.

Andaman Medical is regulatory affairs and market access consultancy specializing in South Asian markets for medical device and in-vitro diagnostics manufacturers who are looking to bring their products to market to ultimately improve the health and quality of life of millions of people.

Unlike other regulatory agencies who outsource to external consultants, Andaman Medical is unique in that it employs fulltime in-house Regulatory Affairs Specialists in its seven local country offices, this means they are well placed to build relationships with the national regulatory authorities.

Since being founded in 2013 by Mourad Kholti, Andaman Medical has registered and acts a local authorised representative for over a thousand different medical devices of all classes. And also offers importation and master distribution services in select countries helping clients literally supply their product to the end user.

With corporate social responsibility part of its DNA, and in response to the worldwide COVID-19 pandemic, Andaman Medical decided to offer its registration services free of charge for those products helping fight the pandemic that could be registered via Special Access Routes to both new and existing clients.

If you have any queries regarding our registration services for medical device registration and representation including Special Access Routes in Singapore, please contact us at contact@andamanmed.com.

2020-06-30T18:02:04+08:00 June 30th, 2020|News & Events|

Complaint Handling for medical devices in Malaysia – new guidance

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Further to the recent Guidance Document for Mandatory Problem Reporting, the Medical Device Authority (MDA) in Malaysia issued another guidance document on 23 June 2020 on Complaint Handling. This new guidance comes into operation on 1 July 2020 as stated in the P.U. (A) 318 released by the federal government. Previously, complaint handling was addressed in The Medical Device (Duties and Obligations of Establishments) Regulations 2019.

Complaints on any medical device can come from users of medical device such as patients, home users, healthcare practitioners, maintenance providers, or the general public. In the newly released guidance document, MDA/GD/0011, Complaint Handling, it states that establishments placing medical devices in the market, whether it be a Manufacturer or their Authorized Representative (AR), an Importer or Distributor, shall have in place a system to handle complaints received. The establishment shall appoint dedicated personnel to handle all complaints.

The elements of the complaints handling system shall include the following:

a) Receiving and recording of complaints. All complaints received shall be recorded and tracked.

b) Assessing the complaint. The criteria to determine whether the complaint is a reportable event shall be established which is based on the nature of the complaint, including but not limited to the following:

    • whether there is a health hazard associated with the medical device;
    • whether the medical device fails to conform to any claim made by the manufacturer relating to its safety, quality, and performance characteristics;
    • whether the medical device fails to meet any legislative requirements; and
    • failure of device, labelling or packaging to achieve the intended purpose of the device;

If the complaint is a reportable event,

    • The complaint shall be communicated to the AR or manufacturer if the complaint was received by the distributor or importer; and
    • a report shall be made by the AR or manufacturer to the Authority within the specified time (Refer to MDA/GD/0014 on Mandatory Problem Reporting).

c) Investigating the complaint. An investigation to determine the root cause of the complaint is carried out when necessary. If investigation is not required, justification shall be prepared and recorded.

d) Implementing corrective and preventive action (CAPA). The need to implement CAPA is determined by the root cause of the complaint that has been concluded in the investigation. If CAPA is not required, justification shall be prepared and recorded. If Field Corrective Action (FCA) is required as CAPA for the complaint, please refer to MDA/GD/0013 on Field Corrective Action.

e) Communicating with the complainant. The establishment may communicate with the complainant on the outcome of the investigation or the action taken to overcome the problem.

f) Recording complaints. All records pertaining to complaint, investigation, justifications and communication to the complainant, the Authority and relevant parties shall be recorded (refer 3.1.1).

g) Closing the complaint. A complaint may be closed as a result of the following:

    • Invalid complaint; or
    • All necessary actions have been carried out and problem(s) resolved.

Complaint records maintained with respect to a medical device shall be retained for a period of 5 years on top of the projected useful life of the medical device as determined by the manufacturer (for example, if the projected useful life of the medical device is one year, the complaint records should be kept for six years).

Click here to read the guidance document  and legislation on the complaint handling for medical devices in Malaysia.

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

2020-06-25T19:33:56+08:00 June 25th, 2020|Insight, Medical Regulation Updates, News & Events|

Medical devices for decontamination in Singapore – new guidance issued

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Critical shortages of respirators have been observed globally during this challenging time of the COVID 19 pandemic. To tackle this situation, there has been significant effort in developing practical methods to decontaminate used respirators effectively. Respirators are generally intended for single use as manufacturers have not validated or developed scientific evidence to support their decontamination and reuse.

Medical devices for decontamination of other previously used medical devices fall under the ‘’Moderate – High’’ risk class and have to be reviewed and approved by Health Science Authority (HSA) prior to their supply in Singapore.  In view of the increasing demand for respirators and the global supply constraints, HSA will facilitate access to safe and effective medical devices for decontamination of single use respirators via the provisional authorisation pathway.

This provisional authorisation is based on a risk-calibrated review process that considers the safety, quality and effectiveness of the decontamination process using these medical devices. The review aims to verify the integrity of the respirators and that their ability to achieve their intended functions such as filtration efficiency and fit is maintained following decontamination. As a post authorisation requirement, periodic reports on any defects or performance issues related to medical devices used for decontamination would have to be submitted to HSA to ensure their continued performance.

Documentary Requirements for the Provisional Authorisation

  • Device Description
  • Evidence that the medical device is effective in reducing the number of pathogens (e.g. sporicidal and viral inactivation studies)
  • Evidence that the respirator’s design and performance specifications remain intact post reprocessing
  • Evidence that there are no residual chemicals (e.g. hydrogen peroxide) on the respirators from the decontamination
  • Comprehensive instructions on safe and effective use of the medical device for users

The guidance allows makes recommendations for healthcare institutions, hospitals and other user facilities on implementing additional measures to ensure the safety, quality and efficacy of these medical devices for decontamination. Click here to read the full guidance document.

If you have any queries regarding medical devices for decontamination or our services for medical device registration and representation in Singapore, please contact us at contact@andamanmed.com.

2020-06-19T16:51:43+08:00 June 19th, 2020|Insight, Medical Regulation Updates, News & Events|

Mandatory Problem Reporting in Malaysia – new guidance document

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The Medical Device Authority (MDA) in Malaysia has released MDA/GD/0014, Guidance Document for Mandatory Problem Reporting which comes into operation starting on 1 July 2020. Previously, mandatory problem reporting was addressed in the legislation, P.U. (A) 318, The Medical Device (Duties and Obligations of Establishments) Regulations 2019.

In this newly released guidance document, MDA/GD/0014, Mandatory Problem Reporting, it states that every establishment shall report any incident involving its medical device which comes to the establishment’s attention whether occurring inside or outside of Malaysia to the Authority only if the medical device is registered in Malaysia. These problems can be reported by submitting Annex A, Mandatory Problem Reporting Form and Annex B, Investigation Form to the Authority.

The establishment shall investigate the cause of incident and conduct field corrective action if necessary, to prevent recurrence of the incident and to ensure safety and performance of the medical device. The Authority will evaluate the investigation report and if the report and action taken are satisfactory, the Authority will inform the establishment in writing to close the matter.

The requirement to submit a mandatory report shall not apply to any incident that occurs outside Malaysia if that incident has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has been taken by the manufacturer or establishment in the country where the incident occurred and on all the affected devices placed in the Malaysian market.

As soon as any personnel of the medical device manufacturers or its authorized representative, including sales personnel, are made aware of the incident, problems must be reported within specific time delays according to the severity of the problem:

  1. within 48 hours after the establishment becomes aware that the incident is a serious threat to public health;
  2. within 10 days after the establishment becomes aware of an incident, if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person, but could do so were the incident to recur; or
  3. within 30 days after the establishment becomes aware of an incident that is related to the failure of the medical device or a deterioration in its effectiveness, or any inadequacy in its labeling or in its instruction for use, if the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person.

However, there are some instances where the reporting is not required. For example:

  1. Deficiency of a device found by the user prior to its use
  2. Service life or shelf-life of the medical device has been exceeded
  3. Protection against a fault functioned correctly (a design feature protected against a fault becoming a hazard)
  4. Expected and foreseeable side effects
  5. Negligible likelihood of occurrence of death or serious deterioration in state of health

Click here to read the full guidance document  and legislation on the mandatory problem reporting for medical devices in Malaysia.

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

2020-06-16T19:03:56+08:00 June 16th, 2020|Insight, Medical Regulation Updates, News & Events|

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|