Vietnam: Business Dialogue Conference on Management of Medical Equipment Regulations

business dialogue

The Ministry of Health, Vietnam has shared with attendees of a business dialogue that the validity of import licenses and the effective date for product licenses Class B, C and D will be extended. The official announcement has been published on the government website..

The Ministry of Health (Department of Medical Equipment and Construction), Vietnam organized a business dialogue conference (3rd of Dec 2019 in Hanoi and on the 14th of Dec 2019 in Ho Chi Minh city) focussing on the regulations of the management of medical equipment and asked for comments on policies supporting the development of domestic production of medical equipment.

The general guidelines about import licenses and product licenses are:
• The import license is valid until 31st of December 2021 for Class B, C, D medical devices for all import licenses issued in 2018 (valid on 31 December 2018) and all import licenses issued in 2019.
• For Class B, C, D medical devices that do not require an import license, importation can continue as normal until 31st of December 2021 without the requirement for a Confirmation Letter from the Vietnamese Ministry of Health.
• Vietnam will apply the Common Submission Dossier Template format until the 1st of January 2022.

In conclusion, the Ministry of Health will expand the valid date for import licenses until the 31st of December 2021 and, the effective date of product licenses for the next two years (1st of January 2022). Every registrant should understand the medical devices that are being registered and the regulations surrounding these.

The new decree is released to public early this month, January 2020. For further information, please refer to the following website: www.dmec.moh.gov.vn

2020-01-13T11:34:42+08:00 December 29th, 2019|Event, Insight, Medical Regulation Updates, News & Events|

Classification of Medical Devices and In Vitro Diagnostic Devices in India

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Medical devices and in vitro diagnostic devices are classified according to the intended use of the device, risks associated with the device, and other parameters specified in the First Schedule

Historically there has been minimal regulation of medical devices in India. However, the medical device industry has changed with the Medical Devices Rules 2017, For the regulation of medical devices with respect to import, manufacturing, clinical investigation, sales and distribution, the Central Government (in consultation with the Drugs Technical Advisory Board) has developed the Medical Devices Rules 2017. This came into effect from the 1st of January 2018 under the provisions of the Drug and Cosmetics Act 1940. The safety and performance of medical devices and in vitro diagnostic devices are regulated under this Act.

Medical devices and in vitro diagnostic devices are classified based on the intended use of the device, risks associated with the device and other parameters specified in the First Schedule. Based on these factors, devices have been categorised into risk classes under the provisions of sub-rule (I), Rule 4 of the Medical Devices Rules 2017. A total of 350 categories of medical devices and 247 categories of in-vitro diagnostic devices have been classified in accordance with the amended Annexure I as of the 6th of June 2018.

Recently, on the 15th of May 2019, further classification of 12 newly notified medical devices have been added to the existing list of classified devices. All these newly notified device types have been assigned moderate to moderate-high Class B and Class C risk classifications:
• CT scan equipment (Class C)
• MRI equipment (Class C)
• Defibrillators (Class C)
• Dialysis machines (Class C)
• PET equipment (Class C)
• X-ray machines (Class C)
• Bone marrow cell separators (Class B)
• Nebulizers (Class C)
• Blood pressure monitoring devices (Class B)
• Digital thermometers (Class B)
• Glucometers (Class C IVD)
• Organ preservation solutions (Class C)

These classifications will come into effect from the 1st of April 2020. These risk classifications will allow the industry to get a better idea of the costs involved, clinical data requirements (if any) and the import licensing authority as they commercialize their products in India.

2020-01-13T09:42:38+08:00 December 29th, 2019|Event, Insight, News & Events|

Andaman Medical Expanding Its Footprint in Asia

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Are you looking into seizing an opportunity in India’s medical device market? Andaman Medical India is commencing its operation in 2020. We are excited to assist you in regulatory matters and contribute to your business development in India. We will be sharing more on our new division soon.

India is the fourth largest medical device market in Asia after Japan, China and South Korea. The current medical device market size is estimated to be worth USD 5.2 billion, with projections that India will become the world’s most populous nation by 2024, with a medical device market size between USD 9.3bn to 10.8bn. This provides an opportunity to help to shape the Indian medical device market and to enhance the quality of life of those living in India.

Andaman Medical may be able to help you to seize this opportunity. From 2020, Andaman Medical will expand its footprint in India. We aim to assist you in navigating the complex regulatory requirements by being the local license holder, facilitating registration processes with authorities, providing regulatory intelligence work and business development services.

For medical device regulations in India, the regulatory body responsible for medical device registration is the Central Drug Standards Control Organization (CDSCO). Only notified medical devices shall undergo registration with CDSCO. Currently, there are about 30 medical device product families that require registration. For example, disposable hypodermic needles, catheters, drug eluting stents and bone cements require registration with CDSCO. By the 1st of April 2020, blood pressure monitoring devices, CT scanning equipment, MRI equipment, defibrillators and dialysis machines are some of the devices that are scheduled for regulation.

We look forward to sharing more information on Indian regulatory updates and news of Andaman Medical India.

Andaman Team India

2020-01-13T09:46:56+08:00 December 6th, 2019|Event, Insight, News & Events|

Medical Device-Drug Combination Product Registration in Malaysia

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A guideline for the registration of drug-medical device and medical device-drug combination products has been released and was fully implemented in Malaysia on 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP).

On the 20th June 2019, a guideline for the registration of drug-medical device and medical device-drug combination products was released. This guideline was fully implemented on the 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP). MDDCP is where the primary mode of action on the human body is not based on pharmacological, immunological or metabolic means, but is assisted by the device to the extent that the Medical

The Medical Device Authority (MDA) is the primary agency of the combination product. All medical devices with substances incorporated, that when used on their own could be considered a medical product, must comply with this regulation. All medical devices that fall under Class D, Rule 13 of the Medical Device Regulations 2012 shall conform to this new directive.

Some examples of medical devices that fall under this section include but are not limited to soft tissue filler or dermal filler that incorporates local anesthetic, synthetic fluid tissue reconstructive material that incorporates a pharmacologically active substance, root canal filling incorporating antibiotics, drug-eluting stents, drug-eluting beads, general-body orifice lubricant incorporating local anesthetic and enteral feeding kits that contain an iodine pack drug.

For a medical device-drug combination product registration, where the MDA acts as the primary agency, the registration process shall undergo 3 stages:
• Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)
• Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
• Stage 3 – Application for Registration to the Medical Device Authority (MDA)

Stage 1 – Obtaining Endorsement from the NPRA
Applicant shall submit the following documents to the NPRA manually:
1. Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
2. Ancillary Drug Dossier (Appendix 2)
Note: for the specific labelling requirement, please refer to Appendix 9: Labelling Requirements, released by the NPRA.
Upon satisfactory evaluation, the NPRA shall issue an endorsement letter.

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
Applicants shall submit the documentation to the CAB. The CAB shall issue a certificate and report upon satisfactory conformity assessment.

Stage 3 – Application for Registration to MDA
Once the applicant has obtained the endorsement letter from the NPRA, certificate and report from the CAB, an application (in accordance with the Medical Device Regulation 2012) shall be made on Medcast 2.0 for the MDA to evaluate the medical device application. The MDA shall register the Medical Device-Drug combination product and issue a medical device registration certificate upon approval.

2019-12-03T05:22:33+08:00 November 25th, 2019|Event, Medical Regulation Updates, News & Events|

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|

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

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The Medical Device Authority (MDA) in Malaysia is organizing both IMDC and myMEDEX to be hosted at the Malaysia International Trade and Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 15 to 17 October 2019. The target audience for these 3-day events includes regulators, industry representatives, researchers, clinicians and members of academia.

The International Medical Device Conference (IMDC) 2019 and Malaysia Medical Device Expo (myMEDEX) 2019 will be held in Kuala Lumpur, Malaysia this October. The Medical Device Authority (MDA) is organizing both IMDC and myMEDEX to be hosted at the Malaysia International Trade and Exhibition Centre (MITEC), Kuala Lumpur, Malaysia from 15th October 2019 (Tuesday) to 17th October 2019 (Thursday). The target audience for these 3-day events includes regulators, industry representatives, researchers, clinicians and members of academia.

The International Medical Device Conference 2019 will provide a forum for medical device regulators, healthcare institutions, healthcare service providers, research institutes, conformity assessment bodies, training bodies, medical device testing laboratories and stakeholders to discuss and share experiences on regulations and quality and safety of medical devices. The purpose of this Forum is to provide a platform for regulators and stakeholders of the medical device industry worldwide to meet and receive updates on current affairs pertaining to the medical device industry.

The Malaysia Medical Device Expo is an initiative by the MDA to highlight the latest innovative technologies and advances of global medical devices. The aim is to create an insightful one-stop center for medical device solutions. The medical device industry is one of the largest industries in global healthcare.

For more information on IMDC 2019, contact the IMDC 2019 secretariat at the following email address: imdc2019@mda.gov.my or on +603 8230 0300.

For more information on myMEDEX 2019, contact the myMEDEX secretariat at the following email address: info@mymedex.com.my or on +603 8070 7666.

2019-10-02T04:13:15+08:00 September 28th, 2019|Event, News & Events|

Indonesia: SIKLARA, the Medical Device Risk Classification System

RAPS

The Ministry of Health (MoH) in Indonesia has introduced a new feature on the registration system website called SIKLARA – a medical device risk classification system aligned with the ASEAN Medical Device Directive (AMDD). SIKLARA has been trialled on the site since mid 2019.

In Indonesia, registrants looking to register a medical device to establish a distribution/marketing license must independently determine the risk class of the device according to the type of product being registered. Medical devices are classified in accordance with the ASEAN Medical Device Directive (AMDD) and the medical device class determines the requirements for registration. The AMDD is a harmonization of medical devices regulations across the ASEAN region and has been incorporated in PERMENKES No. 62 of 2017 concerning the License of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies in Indonesia.

Previously, medical device classification was carried out by the Registrant, then verified/amended by the Evaluator of the Assessment Directorate. An application in which the medical device was incorrectly classified was returned to the registrant for correction. Mistakes in classifying the risk of medical devices can pose risks to the safety of patients. In addition, it can slow down medical licensing services and result in Non-Tax Revenue (PNBP) pricing errors, which can result in state losses due to underpayment. From the registrant’s side, any overpayment cannot be refunded.

Medical device risk classification according to AMDD is not user-friendly and can be difficult to understand. Therefore, to support registrants in determining medical device risk classes independently, the MoH in Indonesia has created a new feature on the registration system wedsite (www.regalkes.kemkes.go.id) known as Sistem Klasifikasi Risiko Alat Kesehatan (SIKLARA). SIKLARA can be found in the information (informasi) menu on the website. SIKLARA is a Medical Device Risk Classification System that aims to identify the risk of medical devices in accordance with the AMDD and has been trialled on the site since mid-2019. The classification of risk of medical devices determines the safety, quality and efficacy of medical devices.

SIKLARA features include:
– Beranda (Home)
– Pedoman (Guidelines):
• Pedoman Klasifikasi (Classification Guidelines)
• Skema Klasifikasi (Classification Scheme)
• PERMENKES 62 tahun 2017 (MoH regulation no. 62 of 2017)
• AMDD
– Klasifikasi (Classification)

SIKLARA is only an electronic general guide that is carried out independently. Information obtained from the results of risk determination using this system does not constitute an absolute decision. The risk classes obtained through this system can be further reviewed by the Assessment Directorate using printable results as proof of self-assessment. The final outcomes of using SIKLARA system are similar to the Health Science Authority’s Risk Classification Analysis Tool. However, this classification system is still not linked to the online registration system, where usually the applicant determines the class based on the category, subcategory and product type of the device. The MoH has not announced when  SIKLARA will be synchronized with the online registration system.

2019-10-02T04:09:19+08:00 September 28th, 2019|Event, Insight, News & Events|

Singapore as a Medical Device Technology Sector Hub

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With the Smart Nation initiative and the shift towards connected devices, Singapore has been able to offer companies a strong and established base to build new business models around big data and patient-centric care.

Today, Singapore is home to more than 60 multinational MedTech companies undertaking a range of activities from acting as regional headquarters to manufacturing, research and development. The Asia Medical Technology market is expected to grow at a CAGR of 8% and is projected to overtake the European Union market as the second largest market globally by 2020 and Singapore’s strategic position would enable MedTech companies to tap into these regional opportunities.

Singapore’s strong design and engineering capabilities, the base of automation suppliers and the presence of high-quality assurance standards have helped it to undertake the manufacturing of high-value medical products. With the Smart Nation initiative and the shift towards connected devices, Singapore has been able to offer companies a strong and established base to build new business models around big data and patient-centric care. All these factors have contributed to Singapore being a critical manufacturing base for diverse medical technology products such as implantable pacemakers, contact lenses and life science instruments for global markets.

According to the Economic Development Board, 60% of the world’s microarrays and one third of the world’s thermal cyclers and mass spectrometers are manufactured in Singapore. Many MedTech companies have established their R&D presence in Singapore, with many investing in end-to-end capabilities ranging from product design, to optimisation and validation; many more leading global MedTech companies have established their regional headquarters in Singapore.

Singapore has a focussed innovative R&D ecosystem which helps MedTech companies flourish. Singapore offers a highly skilled workforce from world class universities together with research institutions and innovative start-ups, which enable MedTech companies to tap into a vibrant innovation ecosystem. With a strong presence of more than 25 R&D centres established by multinational MedTech companies and a local pool of over 220 MedTech start-ups and small-medium enterprises, MedTech companies have increasingly been plugging into this network of innovation, talent and ideas to develop next-generation products and solutions for regional and global markets. Singapore, being a hub for marketing, business innovation, regulatory, and e-commerce, is the ideal place to expand access in Asian markets.

2019-10-02T04:07:56+08:00 September 28th, 2019|Event, Insight, News & Events|

Introducing New Online Courses in Medical Device Registration with Andaman Medical

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Our online e-Learning platform is designed to be flexible and intuitive, breaking down the complicated details of medical device registration and regulatory affairs requirements into a format that is easy to understand and use, allowing you to meet your goals with less time and effort

Navigating the complexities of the diverse medical device/IVD registration and regulatory affairs processes in South East Asia can be challenging. That’s why Andaman Medical has launched a new e-Learning platform offering specialized training to supplement your existing quality affairs and regulatory knowledge. Our online e-Learning platform is designed to be flexible and intuitive, breaking down the complicated details of medical device regulatory and quality affairs requirements into a format that is easy to understand and use, allowing you to meet your goals with less time and effort. By the end of each course you will gain a thorough understanding of the steps of the registration process, how medical device dossiers are compiled and submitted according to regulations, as well as the details of tasks, timelines and costs associated with the process.

This platform is designed to benefit anyone involved in the regulation of medical devices; those in regulatory affairs, local authorized representatives, medical device manufacturers and distributors, healthcare professionals, medical device practitioners, and investors in the medical device sector. An example of one of the courses available is “Understanding the Medical Device Regulatory Pathway in Vietnam”. A course can be completed in as little as one hour of your time, after which your knowledge of the content can be solidified with quizzes. At the end of the course you will be awarded a certificate of completion, which will also show any continuing professional development points you may have earned. To access our e-Learning platform visit https://www.andamanmedtraining.com. Here, you will find the courses listed together with learning objectives so that you can decide whether a course is right for you. Once you find your course, you will be guided through registration to create an account online and begin your course right away. Contact our staff if you would like to find out more about our regulatory and quality affairs training services.

2019-09-01T14:09:30+08:00 August 30th, 2019|Event, Insight, News & Events|