Face masks with valves cautioned against in Philippines

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Face masks with valves have been cautioned against by the Philippines Food and Drug Administration (FDA) in Advisory no. 2020-1374 issued last week. The FDA has advised the public that this type of face mask is not recommended during the COVID-19 pandemic.

As these masks are designed with a one-way valve, they allow exhaled air to pass through a small round or square filter attached to the mask. This means that if the person wearing the valve-mask has the virus, he or she can go on to infect others. So, while the wearer of such a face mask may be able to breathe more easily, they can unknowingly and unintentionally infect others.

As we hear more and more about pre-symptomatic transmission and asymptomatic transmission (see below for explanation), it is vital to use face masks that offer two-way protection. However, the presence of valves may cause potential leaks allowing air to flow out of the respirator face mask. Therefore, such valve-masks should not be used in healthcare settings such as hospitals, clinic and other healthcare facilities or in situations where a sterile field is required such as operating rooms. The FDA further discourages their use in the community particularly enclosed environments such as offices, restaurants, hotels and shopping centres.

The World Health Organisation (WHO) explains the difference and that the distinction is important when developing public health strategies to control transmission:

  • asymptomatic transmission is transmission from people who are infected who never develop symptoms
  • pre-symptomatic transmission is transmission from people who are infected but have not developed symptoms yet.

You can read the full advisory here. If you have any queries regarding the supply of face masks with valves that have been cautioned against in the Philippines or our services for medical device registration and representation in the Philippines, please contact us at contact@andamanmed.com

2020-07-31T16:15:49+08:00 July 31st, 2020|Insight, Medical Regulation Updates, News & Events|

Revised quantity of COVID-19 test kits for evaluation in the Philippines

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Following the issue of new Guidelines on the evaluation of In Vitro Diagnostic Medical Devices and other related Laboratory Diagnostic Supplies for COVID-19 by the Research Institute for Tropical Medicine RITM on July 13, 2020, the Philippines Food and Drug Administration (FDA) issued FDA Advisory 2020-1394 on July 24, 2020.

This advisory reminds all COVID-19 test kit Distributors/Importers who were granted Special Certifications as of April 22, 2020 to adhere to these new guidelines issued by the RITM. The advisory also reminds distributors and importers that all serologic based (Rapid Antibody and Immunoassay) test kits and antigen based test kits shall carry out performance testing as required by the FDA as part of post marketing surveillance. Failure to subject test kits to validation may lead to revocation of Special Certification.

The advisory also states the revised quantity of COVID-19 test kits for evaluation as one hundred (100) tests to be submitted for performance testing. Initially, it was required in FDA Memorandum 2020-011 “Performance Testing of Antibody Test kits with Issued Special Certification” that all companies who have been issued Special Certifications for COVID-19 antibody test kits, shall be required to submit to the RITM three hundred (300) pieces of their respective antibody test kits within thirty (30) days from the date of the notice of submission from the FDA. However, based on the latest guidelines the prescribed quantity of product for evaluation of SARS-CoV-2/ COVID-19 Antibody / Antigen Kit is now 100 tests.

The FDA further reminded all licensed Importers/Distributors of COVID-19 test kits that for subsequent approvals of serologic based test kits and antigen test kits, the guidelines on the submission of documents to the Food and Drug Action Center (FDAC)(what is C?) within 30 days of the issuance of the Special Certification shall remain in effect. This is also stated in the letter entitled, “Performance Testing as Post Marketing Surveillance of COVID-19 Rapid Antibody Test Kits with Issued Special Certification” provided to companies upon issuance of the Special Certification.

You can read the full advisory here. If you have any queries regarding the revised quantity of COVID-19 test kits for evaluation in the Philippines or our services for medical device registration and representation in the Philippines, please contact us at contact@andamanmed.com.

2020-07-30T15:44:55+08:00 July 30th, 2020|Insight, Medical Regulation Updates, News & Events|

Updated guidelines on COVID-19 test evaluation in Philippines

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Updated guidelines on the evaluation of COVID-19 test kits have been released by the Research Institute for Tropical Medicine (RITM) in the Philippines, which cover the “…Evaluation of In Vitro Diagnostic Medical Devices and other related laboratory diagnostic supplies for COVID-19”.

These guidelines cover the evaluation of PCR test kits, in vitro reagents, and other relevant supplies used to screen and confirm SARS-CoV-2 for the diagnosis of COVID-19 such as virus transport media, nasopharyngeal and oropharyngeal swabs. Therefore, all COVID-19 antibody test kits with Special Certification issued by the Philippines Food and Drug Administration (FDA) will be covered by these guidelines.

The guidelines are very concise but specific and detail the documentary requirements to be submitted to RITM, the processes involved from receipt of the documents until approval of the evaluation report, the prescribed quantity of products for evaluation, the fee schedule , turn-around time, as well as guidelines for enquiries, follow up and requests for re-evaluation. The guidelines came into force on July 13, 2020 and were signed by RITM’s Director IV, Dr. Celia C. Carlos, CESO IV.

In accordance with Department Order No. 393 E s.2000 entitled “Designation of National Reference Laboratories and Transfer of Corresponding Equipment, Instruments, Supplies, Specimens, Records from the Bureau of Research and Laboratories”, the RITM is mandated to perform evaluation of test kits and in-vitro diagnostic reagents registered by the Food and Drug Administration to ensure their quality and good performance in the local setting. And with particular reference to the COVID-19 pandemic, the RITM is specifically tasked to perform technical evaluation on reagents and diagnostic kits relevant to COVID-19 testing as per the Department of Health Administrative Order 2020-0014 entitled “Guidelines on Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines”.

Full details of the guidelines can be accessed here: http://ritm.gov.ph/wp-content/uploads/2020/07/Guidelines-Technical-Evaluation-of-Reagents-and-Diganostic-Kits-ver-3.0-07062020-1-signed.pdf

If you have any queries regarding these updated guidelines on COVID-19 test kit evaluation or our services for medical device registration and representation in the Philippines, please contact us at contact@andamanmed.com.

2020-07-29T16:41:01+08:00 July 29th, 2020|Insight, Medical Regulation Updates, News & Events|

COVID-19 Test Price Limit in Indonesia

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A COVID-19 test price limit has been introduced in Indonesia for Rapid Antibody Test Kits by the Director General of Health Services of the Ministry of Health (MOH). The official circular issued on 6th July 2020 has been primarily introduced to avoid price variations in test kits for the public who personally request an independent test in order to obtain a COVID-19 free certificate for travel purposes.

The COVID-19 test price limit for rapid antibody tests has been set at IDR 150,000 (roughly equivalent to USD 10-11) and applies to all health services which provide rapid antibody tests independently.

With a clear price limit in place, the public is guaranteed more transparency and easier access to Rapid Antibody Test examination services. This is of particular importance for people who travel to and from Jakarta city as they must provide an Exit and Entry Permit Letter (SIKM) together with a COVID-19 free certificate. This certificate can be issued by health services such as private hospitals, clinics or laboratories that have carried out a COVID-19 test on the person concerned.

Due to the requirement for a COVID-19 free certificate, many people have requested independent rapid antibody examinations at private health facilities at widely varying prices. The introduction of a maximum retail price was deemed necessary to provide clarity and certainty for both the public as well as providers of Rapid Antibody Test examination services.

COVID-19 testing remains available at Government health facilities for those people who have been in close contact with a positive case or the person themself is a suspect case, i.e. Government health facilities cannot be used for testing simply to obtain a certificate for travel purposes.

Click here to read the full circular on the COVID-19 test price limit in Indonesia for Rapid Antibody Tests.

Regarding sanctions, the Ministry of Health has not yet established concrete sanctions related to violations of the rapid test retail price limit. The Ministry of Health will look further into various aspects related to pricing, both in terms of the community, health care facilities, medical personnel, distributors, and providers of rapid test equipment.

If you have any queries regarding COVID-19 tests in Indonesia or our services for medical device registration, representation, importation and distribution in Indonesia, please contact us at contact@andamanmed.com.

2020-07-21T15:03:15+08:00 July 21st, 2020|Insight, Medical Regulation Updates, News & Events|

Medical device recall in Malaysia – new guidance document

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A Medical Device Recall Guidance Document (MDA/GD/0015) was released by the Medical Device Authority (MDA) in Malaysia on 6th July 2020 however it officially came into operation on 1st July 2020 as stated in the P.U. (A) 318 released by the federal government. Previously, medical device recall was addressed in the legislation, P.U. (A) 318, The Medical Device (Duties and Obligations of Establishments) Regulations 2019.

Recall is any action taken an establishment, whether it be a Manufacturer, Authorized Representative (AR), Importer or Distributor of the medical device, to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied. It also covers notifying the affected person or persons of its defectiveness or potential defectiveness, after becoming aware that the device:

  1. may be hazardous to health;
  2. may fail to conform to any claim made by the manufacturer or Authorised Representative relating to its effectiveness, benefits, performance characteristics or safety; or
  3. may not meet the requirements of the law.

The MDA has the right to order a medical device recall if a medical device possesses a high public health risk in the market. The Authority will monitor the whole recall process. The MDA may also take a role in communicating with stakeholders as necessary. The establishment shall put into place a documented procedure on recall to describe the actions to be taken in initiating and carrying out the recall process in a timely and effective manner to meet the requirements. The recall process is carried out in two phases:
Phase 1) Preparation and Phase 2) Implementation.

A recall may be initiated when there is problem associated with the medical device that may pose a hazard or potential risk to the user(s) or the public, which has been identified through post market information (incident or problem) received from customers. The establishment shall assess the hazard or potential risk presented by the problem associated with the medical device and classify the recall in accordance with Regulation 7 of Medical Device (Duties and obligation of establishments) Regulations 2019. The establishment shall prepare and document a recall strategy, and notify the MDA and the affected person(s), using the form in Annex B attached in MDA/GD/0015.

The establishment shall verify that all affected persons have received the recall notification and have taken appropriate action to recall the medical device. All recalled medical devices shall be identified and isolated accordingly so that that they will not be put back on the market unless rectification has been completed on the said device. The establishment shall collect the recalled medical device, quarantine the medical device and ultimately eliminate the recalled medical device from the market.

The establishment shall submit a recall report within 30 days of the completion of a recall. Recall 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.

Click here to read the guidance document on the medical device recall in Malaysia. The guidance document contains a very informative process flow for medical device recall as well as templates for recall reporting, notifying end users and acknowledging responses.

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

2020-07-10T19:33:02+08:00 July 10th, 2020|Insight, Medical Regulation Updates, News & Events|

Corrective action for medical devices in Malaysia – new guidance

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A Field Corrective Action for medical devices Guidance Document (MDA/GD/0013) was released by the Medical Device Authority (MDA) in Malaysia at the end of June and came into operation on 1 July 2020. Previously, Field Corrective Action (FCA) was addressed in the legislation, P.U. (A) 318, The Medical Device (Duties and Obligations of Establishments) Regulations 2019.

Corrective action for medical devices can be defined as the action taken to eliminate the cause of non-conformities to prevent a recurrence. FCA can arise from post market surveillance information such as product complaints, incidents, market surveys and research development activities amongst others. These can include safety related field corrective actions taken by the manufacturer to reduce the risk of harm to patients, operators or others and/or to minimize recurrence of the event. FCA might also be required by the Authority in cases coming from mandatory problem reporting and for medical devices that are no longer in the market or that have been discontinued but could possibly still be in use (e.g. implants).

Manufacturers, Authorized Representatives, Distributors and Importers shall undertake corrective or preventive action in relation to their medical devices that have been imported and placed in the market. This may include:

  1. the return of a medical device to the manufacturer or its representative (recall);
  2. device modification due to potential non-conformity, which may include:
    • retrofit in accordance with the manufacturer’s modification or design change;
    • permanent or temporary change to the labelling or instructions for use;
    • software upgrades including those carried out by remote access; or
    • modification to the clinical management of patients.
  3. medical device exchange;
  4. medical device destruction; and
  5. specific advice given by establishments regarding the use of the medical device.

Determining the need for FCA is the responsibility of the manufacturer:

a) The manufacturer shall perform a risk assessment in accordance with ISO 14971. The Authority may instruct additional measures by the manufacturer or authorized representative to safeguard public health in case the Authority finds that the risk assessment performed by the manufacturer is deficient.

b) FCA could be triggered from the establishment’s post market surveillance information (product complaint, adverse incidents, etc.) that indicate an unacceptable increase in risk.

The establishment shall submit an FCA report to the Authority within 30 days of completing the FCA or such longer period as the Authority may allow. The Authority may close the FCA and notify the establishment in writing on its decision when all necessary actions have been undertaken and considered satisfactory.

Click here to read the guidance document on the field corrective action for medical devices in Malaysia.

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

2020-07-07T17:08:32+08:00 July 7th, 2020|Insight, Medical Regulation Updates, 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|