| |
| |
Wish you all a Happy New Year! The Lunar New Year is coming. Grand celebration! | |
| |
Access-2-healthcare 's MEDTECH GATEWAY allows you to be closer in touch with the latest in the Medical Technology Markets, Regulations, Policies in Medical Device Market. Enjoy!
| |
| |
Highlights
Regulatory Round-Up Vietnam Officialised Amendments of Medical device Management Acts; Malaysia's new regulations on advertising of medical devices and more
In-Country Focus KMDICA signs MOU with Ho Chi Minh University Medical Center for trial use of Korean medical devices and more
Industry Insights AI used to detect and grade prostate cancer; FDA-approved surgical technique with heart pump and more
Journey to Product Commercialisation Product reached Customers more
|
| |
| |
| |
| |
Vietnam Officialised Amendments 03/2020/ND-CP to Decree No.36/2016/ND-CP & DecreeNo.169/2018/ND-CP on the medical device management | |
India Gives Device Manufacturers Another Year to Meet Drug Regulations India has extended the transition to new rules for certain medical devices by 12 months.Regulators were due to start treating a clutch of devices as drugs on 1January, but have given the industry more time to adapt. Learn more | | | |
| |
| |
FDA finalizes exemptions for certain devices from 510(k) review Devices on the list of exemptions from 510(k) premarket notification procedures range from clinical chemistry and toxicology tests to certain cardiovascular, dental, hearing, neurological, orthopaedic and radiology products.​ Learn more | |
| |
| |
Malaysia: New regulations on advertising of medical devices and obligations of medical device establishments The Malaysian Parliament has gazetted the Medical Device (Advertising) Regulations 2019 (P.U. (A) 317) and Medical Device (Duties and Obligations of Establishments) Regulations 2019 (P.U. (A) 318) under Section 79 of the Medical Device Act 2012 (Act 737) (“Act”) which will only come into effect on 1 July 2020 to allow stakeholders adequate time to comply with all the regulatory requirements.
Learn more
| |
| |
| |
EU's Notified Bodies Tracker | |
The transition deadline for the European Medical Devices Regulation (MDR 2017/745) will be here soon while the list of NBs still keep changing. We'll track the designated and withdrawn Notified Bodies as a permanent feature
| |
.png)
Designated NBs | |  Recent Withdrawals
| | | |
| |
| |
| |
| |
| |
MDCG 2019-16 - Guidande on Cybersecurity for medical devices The Medical Device Coordination Group (MDCG) unveiled new guidance to help manufacturers fulfill all the relevant cybersecurity requirements in Annex I of the MedicalDevices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Learn more | |
| |
| |
| |
Do you have any particular questions or do you want to get industry expert insights about any of our regulatory top?
| |
| |
| |
| |
| |
| |
| |
 VIETNAM
| |
KMDICA signs MOU with Ho Chi Minh University Medical Center for trial use of Korean medical devices
Korea Medical Devices Industrial Cooperative Association (KMDICA) signed a business agreement with University Medical Center in Ho Chi Minh City at the opening ceremony for the Grant and Innovation Center of the university. It is a follow-up to the business agreement signed in August with the Vietnam center, Ho Chi MinhUniversity innovation center and the home medical education center. | |
| |
 CHINA
| |
Medical Examination Center Has Launched English Series Medical Device Registration Examination
Learn more
| |
| |
 PHILIPPINES | |
ASEAN Adds Philippine FDA to GMP Mutual Recognition Program
The Philippine Food and Drug Administration (FDA) has joined a regional mutual recognition program. As part of the Association of Southeast Asian Nations (ASEAN) initiative, the Philippine FDA’s good manufacturing practice (GMP) inspection reports will be accepted by other regional agencies.
Learn more
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
AI can be used to detect and grade prostate cancer
Researchers at Karolinska Institutet have developed a method based on artificial intelligence for histopathological diagnosis and grading of prostate cancer. The AI-system has the potential to solve one of the bottlenecks in today’s prostate cancer histopathology by providing more accurate diagnosis and better treatment decisions. Learn more
| |
FDA approves surgical technique with heart pump
The Food and Drug Administration (FDA) has approved a surgical technique for Abbott’s HeartMate 3 heart pump aimed to allow more advanced heart failure patients to avoid open heart surgery. This is a small, implantable mechanical circulatory support device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. Learn more | | | |
ProHealth joins largest U.S. heart failure device clinical trial ProHealth Carehas enrolled its first patient in a landmark national clinical trial aimed at improving care for those with heart failure. The trial will evaluate improved survival and quality of life with use of the CardioMEMS heart failure system earlier in disease progression. Learn more
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
JOURNEY TO PRODUCT COMMERCIALISATION | |
| |
There was a case of an implant company that was marketed in a particular country, having to deal with a very strange stream of emails and calls, from hospitals that they have never sold to – asking for technical support, filing product complaints, asking for repeat orders...
So the company did a bit of investigation, and asked these hospitals from whom did they receive the product from. It was not from their distributor.
Further investigation revealed that it was another distributor who had sold them, with packaging exactly the same as the implant company’s – just that the product in the package is not what the package says. It so turned out that the implant company’s packaging was being copied by another party and then created the packaging to place another product in to be sold!
Talk about creativity – but also note the potential pitfalls of not having good traceability, up to and including disposal.
| |
| |
Missed our product commercialisation advice from the last issues? | |
| |
| |
| |
Would You Like to Join Us? | |
As we are gradually expanding, we need talent like yourselves in our team to help the growth of the medical technology industry and to provide access to healthcare to everyone.
Contact to join us now! | |
| |
| |
Outreach manager, Logistics (Philippines) | Software V&V Engineer (Thailand) | Regulatory Affairs backend (Thailand) | Sales / Business Development Lead (US) | Sales / Business Development Lead (Germany) | Local Technical Expert, Local market study (Australia)
| | Regulatory Affairs / Quality Systems Manager (full time) (Singapore) | Personal Assistant (full time) (Singapore) | Human Resource Executive (Singapore) | Regulatory Affairs (Korea) | RA, Logistics (Indonesia) | | | |
| |
| |
| |
| |
| |
helps medical technology companies with their product development, market launch and to gain market entry in various countries. Learn more about us through our SlideShare
Access-2-Healthcare has been recently awarded as Best SME Medical Technology Consulting Solutions Provider - Asia Pacific, by Global Health & Pharma
| |
| |
| |
MISSED OUR LAST ISSUE?
In our last issues, we have gone through the top regulatory news of worldwide healthcare industry: ISO 14971:2019 Medical devices; TAIWAN Medical device Management Act; EMA Subgroup Questions Use of NBs to Assess Companion Diagnostics; COPD treatment system receives CE marking to name a few.
Click to view the DECEMBER 2019 newsletter Or vist our website for more issues and feedback!
| |
| |
| |
| |
| |
