The MHRA provides guidance onthe influence of human factors on medical devices

Intended for manufacturers, developers and notified bodies, the guidance from the Medicines and Healthcare products Regulatory Agency (MHRA), UK focuses on the influence of human factors on safety risks. This includes the design and optimisation of medical devices, as well as device components of drug-device combination products that are regulated as medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has provided guidance on how human factors can impact the design for medical devices to ensure patient and user safety. Intended for manufacturers, developers and notified bodies, the guidance focuses on the influence of human factors on safety risks. The guidance includes design and optimisation of medical devices, as well as device components of drug-device combination products that are regulated as medicines. A Human Factors Task and Finish group has been formed to support the initiative for patient safety and includes members from MHRA, academia, industry, NHS Improvement, NICE, notified bodies, professional associations, and trade bodies.

The guidance applies to the design of new devices and changes in user interfaces of existing products. In addition to design, the guidance advises on testing and validation of design stages, as well as the post-market phase that might suggest certain design improvements during clinical practice. It urges device manufacturers to apply a usability engineering process to identify, assess and reduce potential patient and user safety risks. The process can also be applied during the analysis of prior incidents to identify and implement corrective actions to improve device design.

Read the guidance document here.

2018-01-08T17:36:26+08:00 September 29th, 2017|News & Events|

The FDA Philippines gears up for the 1st Regulatory Advocacy Fair and Back-to-Back QPIRA Training sessions for 2017

The FDA Philippines, in cooperation with the Philippine International Convention Center (PICC), met with industry representatives during the 1st Regulatory Advocacy Fair, coinciding with the 54th anniversary of the FDA as a health product regulator.

In August, the Philippines Food and Drug Administration, in cooperation with the Philippine International Convention Center (PICC), met with industry representatives to brief them on the guidelines for exhibitors to the 1st Regulatory Advocacy Fair at PICC, coinciding the 54th anniversary of the FDA as a health product regulator. The government agency, under the Department of Health (DOH), is more than half-a-century old, but it has taken a youthful approach as far as the services it renders to the public are concerned.

Coincinding with the celebration, the FDA had initiated activities which not only showcase the Agency’s milestones but extend its services to valued stakeholders. One of the main activities was the Qualified Person in the Industry Regulatory Affairs (QPIRA) training sessions for Food, Drugs, Cosmetics and Medical Devices. In this event, subject to rules and guidelines that had been strictly implemented, the FDA had an avenue to promote awareness and learning for its stakeholders; to showcase industry best practice; to highlight professional organization membership, regulatory affairs success stories, quality management practices, product safety projects, and anti-counterfeit programs.
The objectives of the event are:

  • To hold a back-to-back event that will promote awareness of the FDA’s mandate and the role of its stakeholders;
  • To conduct simultaneous QPIRA training sessions to promote good submission practice and good regulatory practices;
  • To supplement learning from QPIRA lectures through the Regulatory Advocacy Fair and provide up-to-date information with regard to health products regulated through a showcase of best practices and advocacy programs from industry stakeholders and partner government agencies; and
  • To provide training for trainers i.e., to develop technical trainers in the Regional Field Offices (RFO).

The advocacy fair featured booths displaying the profile of major stakeholders in the food, drug, cosmetic and medical device industries. The FDA Director General informed the public that the fair was part of FDA’s advocacy efforts to engage the general public and capture stakeholders to foster a dynamic regulatory cooperation. Likewise, the FDA stakeholder industry associations showcased their advocacy activities and best practices, described the benefits of compliance to FDA rules and regulations, and of joining professional organizations in regulatory affairs. Aside from the FDA and other industry stakeholder associations, the initial lineup of FDA-partnered government entities who joined the fair included the Department of Health (DOH), the Philippines National Police (PNP), the Food and Nutrition Research Institute, the Department of Trade and Industry (DTI) and the Department of Agriculture (DoA). Overall, the event was a success. We wish the FDA all the best for its future endeavours as it marks its anniversary.

2018-01-08T17:37:17+08:00 September 29th, 2017|News & Events|

30th Indonesian Hospital Expo in Jakarta

Save the date for the 30th Indonesian Hospital Expo, which takes place from October 18th – 21st 2017 at the Jakarta Convention Center. This eventful expo will be attended by doctors, hospital management teams, medical device manufacturers, nurses, pharmacists, academic colleagues, press and the public.

Another exciting medical device event is happening this October in Indonesia. Taking place at the Jakarta Convention Center (JCC), which is widely known for its large exhibition space and convenient access, the 30th Indonesian Hospital Expo will be held from October 18th – October 21st 2017. Two congress events will also be convened here: the 15th National Seminar of the Indonesian Hospital Association (IHA) and the 11th Annual Seminar on Patient Safety.

This 4-day event will be attended by local and international doctors, hospital management, hospital quality control teams, medical device manufacturers, nurses, pharmacists, academic colleagues, press and the public. There will be an extensive range of products  being exhibited from around the world, such as Europe, Africa, the USA, Japan and China. The exhibits are well organized and range from medical equipment and devices to storage solutions. Pharmaceutical manufacturers and practitioners are encouraged to attend as there are also exhibits for pharmaceutical production equipment and medical supplies.

Indonesia offers good opportunities for medical device manufacturers. With few local medical device manufacturers and a population of over 250 million, Indonesia remains dependent on foreign-manufactured medical devices. This event provides a good opportunity for medical device manufacturers to showcase their products to prospective customers and network with potential business partners.

2018-01-08T17:37:54+08:00 September 29th, 2017|News & Events|

IVD Analysers: Clarification on Risk Classification and New SMDR Listing Option by HSA Singapore

The Health Sciences Authority Singapore conducted a seminar on the clarification of the risk classifications for IVD analysers to support the change notification process for applicants. Also, a new guidance document, GN-34, has been put in place to act as a one-stop document for IVD analyzers.

On the 11 September 2017, the Health Sciences Authority of Singapore conducted a seminar on clarifications made to the risk classifications for IVD analysers to support the introduction of a new SMDR listing option. The current approach involves the submission of multiple change notification documents per device risk classification even in the event that there are identical changes affecting the same analyser in multiple device listings of the same class. This can be extremely onerous when multiple risk classes are involved. Furthermore, model listing amendments have to be done manually and uploading all the necessary documentation can be time consuming. Industry feedback from several focus-group discussions has revealed that companies have requested for an option where analysers can be listed separately from the reagents. As a result, a SPLIT listing option in addition to the IVD listing option, has been newly introduced by the HSA to ameliorate this issue. If the premarket application already includes an IVD analyser that is currently listed in the SPLIT listing on the SMDR, the analyser can be excluded from the Annex 2 list of configurations and the analyser supporting documents do not need to be submitted.

Clarifications regarding the IVD analysers were also made to distinguish between standalone and closed-system analysers. The risk classification of standalone analysers depends on the intended purpose of the IVD analyser. In contrast, closed-system analysers take the highest risk class of all the reagents it is compatible with. The online classification tool introduced by the HSA can help to facilitate risk classification of IVD analysers. Furthermore, a new guidance document, GN-34, has been put in place to act as a one-stop document for IVD analyzers. It touches on the risk classification, SMDR listing options, FAMILY grouping, product registration and change notification of which the FAMILY grouping is a new way to group permissible from non-permissible variants. More information can be found here and the consultation period on the draft GN-34 document ends on the 15 October 2017.

2018-01-08T17:38:39+08:00 September 29th, 2017|News & Events|