FDA Philippines to Ban Powdered Medical Gloves and shall Implement the Gradual Switching to Powder-Free Gloves

To ensure safety, the Philippines FDA will ban powdered medical gloves and have advised the general public, including all healthcare professionals, that powdered gloves will be phased out by the end of 2018 in favor of powder-free medical gloves.

The Philippines Food and Drug Administration (FDA) has released an Advisory No. 2017-180, dated June 20, 2017, which pertains to the risks posed by the following powdered medical gloves:

  • Powdered Surgeon’s Gloves
  • Powdered Patient Examination Gloves
  • Absorbable Powder for Lubricating a Surgeon’s Gloves

This advisory is based on the US Food and Drug Administration (USFDA) Medical Device Bans DN: 2016-30382, that the powdered medical gloves “present an unreasonable and substantial risk of illness or injury, and that the risk cannot be corrected or eliminated by labelling or a change in labelling”. The health authority cited potential consequences including inflammation, granulomas, and respiratory allergic reactions.

Following the USFDA ban of powdered medical gloves, the Philippines FDA shall adopt the use of powder-free medical gloves and has advised the general public, including all healthcare professionals, that the powdered medical gloves will be gradually phased out by the end of 2018. Please be advised that the advisory does not apply to powdered radiographic protection gloves; powder used in the manufacturing process of non-powdered gloves, and powder intended for use in or on other medical devices such as condoms.

Effective 1st January 2019, all applications for product certifications and/or other authorizations for powdered gloves will no longer be accepted. All valid Certificate of Product Registration (CPRs) issued prior to December 31, 2018 will automatically be revoked, terminated or cancelled due to the potential danger posed to clinicians and the general public. The importation, sale, manufacture or distribution of abovementioned medical devices will be prohibited from the 31st December 2018. Any infringement will be considered as a direct violation of Republic Act. No. 9711 or the Food and Drug Administration Act of 2009.

2018-01-08T17:42:20+08:00 July 27th, 2017|News & Events|

Vietnam: Imported Medical Devices Will require Registration in 2017

Companies currently selling imported medical devices in Vietnam should note that any import licenses they are holding will only remain valid through to June 30, 2017, for Class A medical devices, and through to December 31, 2017, for medical devices in the other classes. With the possibility of a backlog for approving the new MA licenses, we recommend that companies submit their applications early.

On May 15, 2016, shortly before the new Law on Pharmacy was adopted, the Vietnamese government issued Decree No. 36/2016/ND-CP on the management of medical devices (Decree 36). This decree came into effect on  1st July 2017, bringing medical devices under uniform management. Previously, there were two separate systems of legislation—one for medical devices manufactured domestically and the other for imported medical devices. All domestically manufactured medical devices had to be registered and granted marketing authorization licenses (MA licenses) from the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health before being circulated. Foreign medical devices, on the other hand, did not require registration but had to obtain import licenses from the DMEHW to be imported and circulated in Vietnam.

Commencing in 2017, all medical devices imported into Vietnam will require marketing authorization (MA) licenses. Under this legislation, a foreign medical device company can allow its Vietnam representative office or subsidiary, or another third-party local entity, to be the MA holder. The MA holder does not have to be the importer/distributor of the medical devices.

The Ministry of Health began receiving registration dossiers on January 1, 2017, for medical devices categorized as Class A, and will begin receiving dossiers on 1st July, 2017, for medical devices in Classes B, C, and D. Class A medical devices are considered “lowest-risk,” and include products such as bandages, surgical gloves, and IV tubes, while Class B, C, and D medical devices are generally higher-risk and/or more invasive products, such as contact lenses, pregnancy test kits, and artificial hearts.

Companies currently selling imported medical devices in Vietnam should note that any import licenses they are holding will only remain valid through to June 30, 2017, for Class A medical devices and through to December 31, 2017, for medical devices in the other classes. With the possibility of a backlog for approving the new MA licenses, we recommend that companies submit their applications early.

2018-01-08T17:52:58+08:00 July 27th, 2017|News & Events|

Draft List of Medical Devices Released by CDSCO, India

The Central Drugs Standard Control Organization (CDSCO) of India has confirmed that the Medical Device Rules, 2017 will come into effect on the 1st January 2018. Currently, 462 medical devices and 250 in vitro diagnostic medical devices have been allocated a risk class and included in a draft list of medical devices affected by the Medical Device Rules.

Following up on our article published in April titled “India: New Medical Device Rules 2017”, the Indian regulator has now published a draft list of medical devices and in vitro diagnostics that will be affected by the Medical Device Rules, along with their risk classes.

The draft list is comprised of 462 medical devices, such as cannulas, catheters, needles, stents and prostheses, and 250 in vitro diagnostic medical devices including instruments, analysers, receptacles used for in vitro diagnostic procedures, various types of clinical chemistry reagents and kits, and devices for self-testing. The devices are classified based on their risk class, ranging from Class A to Class D, with the latter being the highest risk.

The Central Drugs Standard Control Organization (CDSCO) has confirmed that the Medical Devices Rules, 2017 will come into effect on the 1st January 2018. It is also anticipated that the Indian regulators will issue additional drafts of the medical device classification list in the coming months. We will keep you updated on the situation. The draft list of medical devices and in vitro diagnostic devices is available on the CDSCO website.

2020-08-06T17:46:34+08:00 July 27th, 2017|News & Events|

Andaman Medical Facilitates the Importation of Consult Station® in the Philippines

Consult station

Andaman Medical has facilitated the very first importation of Consult Station into the Philippines. The autonomous medical unit offers health checks and promises to revolutionize health services to the Filipino people through the use of innovative healthcare technology.

Andaman Medical has facilitated the very first importation of Consult Station, manufactured by H4D France, into the Philippines. Consult Station is an autonomous medical unit that replicates a medical doctor’s office using unique, fully-certified technology. The station performs health checks including the measurement of physiological parameters and vital statistics as part of a collective prevention program.

Currently, Consult Station is not listed in the Philippine FDA’s Memorandum Circular no. 2014-005 as a medical device that requires mandatory registration prior to its sale, distribution, and use. However, to import the Consult Station into the country, additional regulatory requirements and certifications were required to confirm the device’s safety and efficacy, and to meet customs’ requirements. With Andaman Medical’s regulatory expertise in ASEAN markets, Andaman Medical Philippines ensured full compliance to ensure all necessary local requirements were met within the specified timeline.

In June 2017, H4D, in partnership with their local insurance partner, EastWest Ageas Life Insurance Corporation “Troo”, launched the Consult Station at Ibiza Beach Club, BGC, as part of their mission to provide the best possible healthcare for Filipinos through the use of the latest healthcare technology. Coinciding with the launch of Troo, the event, aptly named “Living Colors”, was a colorful affair. Among the presenters at the event were Troo President & CEO, Mr. Loozekoot; the President of H4D, Dr. Baudino; and Forbes’ top 50 influencer Mr. Qualman. The event was a success and marked the start of a partnership that promises to bring innovative health services to the Filipino people.

2018-01-08T17:44:26+08:00 July 12th, 2017|News & Events|

Entering European Markets: The New EU Medical Device Regulations

EU medical device regulations

The new EU Medical Device Regulations were established on the 25th May 2017 with full application of the MDR coming into effect on the 26th May 2020. Here we highlight some of the changes in EU Medical Device Regulations.

The new EU Medical Device Regulations (MDR) were established on the 25th May 2017 with full application of the MDR coming into effect on the 26th May 2020. The new regulations have introduced a Unique Device Identification (UDI) System. In addition, new classification rules were enforced and the regulations now include products without a medical purpose. During the transition, manufacturers can choose to comply with the Medical Device Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD), but any certificates issued under these directives will expire four years after the MDR comes into effect in 2020. Below are some highlights of the changes in the EU regulations:

The Introduction of a Unique Device Identification (UDI) System. The new EU Medical Device Regulations enhance traceability requirements of medical devices throughout the supply chain by requiring that a UDI is affixed to a medical device or to its packaging. Each component that is considered a medical device and is commercially available on its own, will be assigned a separate UDI.

The Inclusion of Products Without a Medical Purpose and New Classification Rules. There are some classes of products that do not have an intended medical purpose but the products have a risk profile that is similar to medical devices; thus, they have been included in the new EU Medical Device Regulations. Examples of such devices include non-prescription contact lenses; facial, dermal, or mucous membrane filling substances or articles; liposuction equipment; laser equipment for skin treatment; and equipment that applies electrical or magnetic currents for brain stimulation.

Joint Responsibility of Authorized Representatives. Non-EU manufacturers of medical devices and IVDs must appoint a European Authorized Representative in the European Union. Under the new EU Medical Device Regulations, the European Authorized Representative will be responsible for verifying that the EU Declaration of Conformity and technical documentation have been drawn up by the manufacturer and, where applicable, that an appropriate conformity assessment procedure has been conducted. Most importantly, the European Authorized Representative will be legally liable, jointly and severally, with the manufacturer, for defective devices that are placed in the EU market if the medical devices are not compliant with the requirements stated in the Regulations.

To prepare for the MDR, manufactures must plan ahead and conduct a thorough review so that they know where to focus most of their time and effort.

2018-01-08T17:45:03+08:00 July 12th, 2017|News & Events|

A Revolutionary Medical Device: Influenza Vaccination Without Needles

flu vaccination microneedles

Band-Aid-like patches with dissolvable microneedles promise to revolutionize influenza vaccination. This prospective vaccine technology could offer economic and manufacturing advantages over traditional vaccinations.

Many people have a misconception that the flu and common cold are the same. In fact, the diseases are caused by different strains of viruses and the symptoms of flu are generally far worse and more intense than those of the common cold. In tropical regions (such as the countries in Asia: Malaysia, Singapore, Thailand etc), outbreaks of influenza may occur throughout the year. According to the World Health Organisation (WHO), these annual epidemics are estimated to result in about 3 to 5 million cases of severe illness, and about 250,000 to 500,000 deaths.

On the 8th March 2017, Malaysia reported its first H5N1 avian influenza outbreak in Kelantan since 2007. A few days later, over 200 students were quarantined for Influenza A in Perak. Vaccination is the best route to manage the disease. According to Datuk Dr Christopher K.C. Lee, head and senior consultant physician (infectious diseases) at the department of medicine, Sungai Buloh Hospital, influenza vaccination rates in Malaysia are very low due to a lack of awareness of the dangers of influenza despite the vaccines being available for decades.

On the 27th June 2017, a phase I clinical trial conducted by Emory University in collaboration with researchers from the Georgia Institute of Technology found that influenza vaccination using Band-Aid-like patches with dissolvable microneedles was safe and well-tolerated by study participants, was just as effective in generating immunity against influenza, and was strongly preferred by study participants over vaccination with a hypodermic needle and syringe. Results of the trial showed that 96% of participants vaccinated with the patch found the process to be pain-free. Moreover, the patch provided strong immunity and 70% of those who received the patch preferred the method to traditional injections.

This prospective vaccine technology could offer economic and manufacturing advantages over traditional vaccinations. The manufacturing cost of the patch is expected to be competitive with prefilled syringe costs; however, use of the patch can dramatically reduce the cost of vaccination programs because self-administration eliminates the need to have health workers oversee the process. The patches can also be easily packaged for transportation, they require no refrigeration, and are easily disposed of after use without sharps waste.

It will be possible to introduce this medical device into Asian markets once clinical trials have been successfully completed.

2018-01-08T17:45:51+08:00 July 12th, 2017|News & Events|