MARA 2016
For more information on the program and speakers or to register, please visit the event website at:
Looking forward to meeting you there!
David and Goliath in the female incontinence mesh battle!
The company, along with other medical device makers, have been hit with series of lawsuits related to transvaginal meshes, intended to treat pelvic organ prolapse. Last July, Endo settled a batch of product liability lawsuits brought against subsidiary American Medical Systems Holdings over its pelvic mesh implants.
The FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the products under its most stringent level of review, Class III, in January.
CL Medical with their I-STOP female incontinence mesh supported by strong clinical evidence, is proving, not only the efficiency of the product, but also its quality. With this product of such high standard, the manufacturer is positioned to take advantage in the market. Indeed, with several players removing themselves from the market, CL Medical could become a dominant player in the incontinence field.
LOK Corporation is proud to be their partner as international manufacturer agent.
For more information on the products and explore the opportunity for your market, please contact our manufacturer agent department at clmedical@lok-corporation.com
LOK Corporation International Ltd. signs exclusive Territory management agreement with LIDCO Group.
London, February 16th 2016 – LOK Corporation International Ltd. has signed an exclusive territory management agreement between their Alliance Medical division and the UK based hemodynamic monitoring company LIDCO (AIM:LID).
Alliance Medical is committed to promote exclusively all LIDCO products by taking responsibility for the distribution management, regulatory compliance support and marketing activities for the Canadian and South African markets.
« We are very excited to associate ourselves with a well-established Company like LIDCO, we are convinced that Alliance Medical Canada and Alliance Medical South Africa will contribute to expand the brand recognition of LIDCO in these markets » said Daniel Cloutier CEO for LOK Corporation International Ltd.
About LIDCO
LIDCO is a supplier of minimally invasive hemodynamic equipment for hospitals, to monitor the amount of blood flowing around the body and ensure that vital organs are adequately perfused and oxygenated.
LIDCO’s technology, developed at St Thomas’ Hospital in London, has been shown to significantly reduce morbidity & complications, length of stay and overall costs associated with major surgery.
About LOK Corporation International Ltd.
The Company operated under two main divisions; LOK Network providing regulatory compliance services and manufacturer agent services with 12 offices worldwide and Alliance Medical providing territory management services with branches in Canada, Russia & EEU, GCC, South Africa and India & SAARC.
LOK Corporation team will be attending AAOS meeting in Orlando 1-5 March 2016!
We will be delighted to see you at the Booth #4023! Do not hesitate if you would like to schedule a meeting either for this product or any services of LOK Corporation.
For contact form click here
17-18 February THE 3RD ANNUAL AFRICA HEALTHCARE SUMMIT 2016
Due to the increase of GDP in several Countries, it is not surprising to find out that government Healthcare spending rank #2 in Africa. The Healthcare sector is forecast to grow tremendously years ahead, creating exiting opportunity for the medical industry!
Like us, if you are interested in the latest Healthcare developments, where are the challenges and investment opportunities across the continent and finally what to expect as reforms, this summit is the best place to find out!
Would you like to discover more about Medical Device distribution in Africa? Just connect with us and our representatives at the summit will be happy to meet you there and discuss this exciting dynamic of the African market!
11-13 March 2016 – MEDICAL FAIR INDIA 2016
The healthcare sector is predominant in the Indian economy, not surprising that it is one of the leading market for a majority of medical device manufacturers.
Take advantage of meeting on site with one of our representatives, either you are a visitor or manufacturer, we want to know about you! Click here to schedule a meeting
Official website of Medical Fair India 2015
(SAARC) The South Asian Association for Regional Cooperation.
Transition Plan for the Medical Device Single Audit Program (MDSAP)
Background
The Medical Device Single Audit Program (MDSAP) was initiated at the International Medical Devices Regulators Forum’s (IMDRF) inaugural meeting in Singapore in 2012.
The program was designed and developed so that a single audit, performed by an authorized Auditing Organization (AO), meets the quality management system (QMS) requirements of multiple regulatory agencies, derived from the International Organization for Standardization (ISO) 13485:2003. Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits. In addition to Health Canada, the participating agencies are the Australian Therapeutic Goods Administration (TGA), the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA), the Japanese Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the United States Food and Drug Administration (FDA).
Transition Plan
The Pilot is scheduled to conclude December 31, 2016, and as stated in Health Canada Notices dated January 2014 and January 16, 2015, Health Canada intends to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Devices Regulations (the Regulations). MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin at the conclusion of the Pilot on January 1, 2017, and will span a period of two years. During this two years’ period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted. Further details will be released as the transition plan is finalized. Health Canada’s transition to MDSAP is an attempt to align with the transition period for the revised version of ISO 13485, which is anticipated to be published in early 2016.
Publication of Medical Device Inspection Information
The database will consist of three main elements.
1. Lists of Inspections. The database will include general information (name, date, rating) on all medical device inspections since January 1, 2012 to present.
2. Initial Inspection Deficiencies provide a preliminary overview of the inspection findings and are published within 3 days of the inspection.
3. Inspection Report Cards offer plain language summaries of inspections and they are published within 30 days of the inspection. The Report Cards will include a detailed information such as information identifying the establishment, date of the inspection, inspection type and rating, etc.
For an up to date listing of medical device establishment licenses, or further information about Health Canada’s Regulatory Transparency and Openness Framework can be found on Health Canada’s website.
New EU legislation on its way
In the mean time, following the partial agreement in June 19, the European Council has made some technical corrections to their agreed texts.
The Council Workgroup as well as the Parliaments rapporteurs and shadow rapporteurs have started to prepare for their positions in the trilogue negotiations.
Some of the aspects in the debate are relatively new, such as the grandfathering options and the selective assessment schemes for products already on the EU market.
The sessions started mid-October, with 3 meetings conducted and 3 scheduled at this stage: two in November and one in December. Significant preparation has gone, and will go into each of these sessions, the first of which concentrated on chapter I and Annexes I-V of both MDR and IVDR.
Luxembourg, the current chair of the European Union, is striving towards finalization. The further key issues prone to compromises are the following:
- clinical studies versus literature
- scrutiny process
- notified bodies and their supervisory structures
- reprocessing of single use device
Assuming a positive scenario, legislation may be finished towards the middle of 2016.