CT-MRI Society of the Philippines Conference

conference

Thousands attended the 2019 joint conference held by the CT-MRI Society of the Philippines and Ultrasound Society of the Philippines event to discuss scientific programs that involve new treatments, therapies, techniques, as well as new ground-breaking technology and innovation.

The CT-MRI Society of the Philippines and Ultrasound Society of the Philippines held its 2019 Joint Annual Convention with the theme “Basic and Advanced Imaging: Heading Down to Sound Decisions” on October 24-26, 2019 at the Manila Hotel’s Fiesta Pavilion. Thousands of radiologists, radiologic technologists, trainees from the government and private sector, as well as foreign delegates and speakers attended this event to discuss scientific programs that involve new treatments, therapies, techniques, as well as new ground-breaking technology and innovation.

The convention was sponsored by some of the notable medical device companies in the Philippines. In addition, exhibitors from the medical device industry that supply diagnostic imaging medical devices attended the 3-day event. Participant exhibitors showcased their products and took the opportunity to meet with their end-user clients and prospects to promote their products and services as well as create brand awareness.

2019-11-01T05:29:40+08:00 October 29th, 2019|Event, Insight, News & Events|

Reminder of Medical Device status of Non-Corrective Contact Lenses in Malaysia

Contact lenses

Non-corrective contact lenses are also known as cosmetic, decorative, colored or fashion contact lenses. This is a gentle reminder to those non-corrective contact lens manufacturers to register their contact lenses with the Medical Device Authority (MDA) before the devices are placed on the market.

Non-corrective contact lenses were regulated as medical devices by the MDA in Malaysia as of the 1st of January 2018. This is a gentle reminder to those non-corrective contact lens manufacturers to register their contact lenses with the MDA before the devices are placed on the market.
Non-corrective contact lenses are also known as cosmetic, decorative, colored or fashion contact lenses in the market. According to the Medical Device (Declaration) Order 2017, released on the 14th of September 2017, “non-corrective contact lens” means a contact lens which is not used to correct, remedy or relieve any refractive abnormalities or optical defects of sight. Non-corrective contact lenses are used to change the look or color of a user’s eyes. Unlike corrective contact lenses, they do not correct vision.

Non-corrective contact lenses, just like corrective contact lenses can pose serious risks if they are obtained without a prescription or not used correctly. The risks include:

• A cut or scratch on the top layer of the eyeball (corneal abrasion)
• Allergic reactions like itchy, watery red eyes
• Blindness
• Decreased vision
• Infection

All types of contact lenses have associated risks. Thus, the MDA regulate non-corrective contact lenses as medical devices. Manufacturers of non-corrective contact lenses shall obtain ISO 13485 certification. According to the Medical Device Regulations 2012, non-corrective contact lenses shall be considered as Class B or C medical devices, depending on the duration of use.

2019-11-01T05:37:42+08:00 October 29th, 2019|Insight, Medical Regulation Updates, News & Events|

Vietnam National Single Window as a Singular Product Registration Website

Halal

The Ministry of Health (MoH) of Vietnam has introduced a new feature on their registration website system (the Vietnam National Single Window) that combines two registration systems – import and product license – into one website.

Previously, a registrant had to (1) register on the Vietnam National Single Window website (VNSW) for an import license, and (2) set up an account on the Department of Medical Equipment and Construction website (DMEC) for a product license. As of mid-October 2019, one account in VNSW will be sufficient for both import license and product license registration. The system is currently being trialled on the site; the official system will be implemented on January 1, 2020.

According to the authorities, the registration number on the dossier submitted via the Department of Medical Equipment and Construction (DMEC) will not change, thus no update is required. The system will automatically transfer the information to VNSW for follow-up and to receive feedback from the previewer. By using the VNSW to send information and electronic documents, customs declarants can carry out customs procedures in addition to procedures of the state management agencies related to exported and imported goods through one integrated information system.

State management agencies decide whether goods should be allowed to be exported, imported or transited; customs authorities decide customs clearance and release goods on the integrated information system. The list of administrative procedures of medical equipment registration after implementation includes:

1. Issuing an import license for medical equipment
2. Issuing a product license for medical equipment
3. Assigning a certificate of trading class B, C, D medical equipment
4. Granting a Certificate of Free-sale
5. Announcement of eligibility for classification of medical equipment
6. Obtaining a medical equipment classification practice certificate
7. Announcement of eligibility for technical services of medical equipment
8. Announcement of facilities eligible for testing and calibration of medical equipment
9. Announcement of eligibility for production of medical equipment

2019-11-01T05:42:45+08:00 October 29th, 2019|Insight, Medical Regulation Updates, News & Events|

Malaysia Medical Device Expo (myMEDEX) and International Medical Device Conference (IMDC) 2019

Malaysia Medical Device Expo

The opening ceremony for these events was launched by the Prime Minister of Malaysia, Tun Dr. Mahathir bin Mohamad, in the presence of the Minister of Health, Datuk Seri Dr. Dzulkefly Ahmad. The Prime Minister said that Malaysia could strengthen its global market competitiveness by providing a conducive business environment for multinational companies.

The Malaysia Medical Device Expo (myMEDEX) and International Medical Device Conference (IMDC) were held concurrently at the Malaysia International Trade & Exhibition Centre (MITEC) from the 15th October 2019 to 17th October 2019.

The opening ceremony was launched by the prime minister of Malaysia, Tun Dr. Mahathir bin Mohamad, in the presence of the Minister of Health, Datuk Seri Dr. Dzulkefly Ahmad. Prime Minister Tun Dr. Mahathir bin Mohamad said that Malaysia could strengthen its global market competitiveness by providing a conducive business environment for multinational companies. Besides that, Tun Dr. Mahathir stated that Malaysia is the world’s largest producer and leading exporter of rubber gloves, contributing 63% of the global supply while the export revenue was projected to reach a total of RM19.88 billion in 2019.

On the first day of the International Medical Device Conference (IMDC), a few well-known speakers were invited to provide a presentation. Ms. Quan Tran gave a presentation focusing on the ASEAN Medical Device Directives, and Mr. Thomas Stefen Brand gave a talk on the “Challenges of the New European Union Medical Device Regulations for Medical Device Companies”. Later that day, the participants were given three tracks to choose to attend: regulatory requirements, medical device research environment, or state of the arts.

On the second day of the event a few topics were presented, including Global Strategy for Digital Health, R&D&C&I of Medical Device in Malaysia, Unlocking Innovation in Healthcare, Spearheading Healthcare Innovation with Internet of Things and Big Data, and Supporting Innovation and Faster Access to Safe Medical Devices. In the afternoon, the Medical Device Authority (MDA) in Malaysia updated the industry players on the new regulations, focusing on the re-registration requirements, prohibition order & advertisement, and post-market, surveillance & vigilance (PMSV) & enforcement. The group discussed the possible routes taken by the Authority to implement the regulation. It is expected that new regulations will be introduced in year 2020.

With the conclusion of myMEDEX and IMDC, the government hopes that industry players can continue innovating and revolutionizing processes and business models in the medical devices industry.

2019-11-01T06:02:32+08:00 October 29th, 2019|Insight, Medical Regulation Updates, News & Events|