Malaysia: Control of Orphaned, Obsolete and Discontinued Medical Devices in Hospitals, Healthcare Institutions or Any Related Facilities

Halal

On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical devices in hospitals, healthcare institutions or any related facilities. According to the circular letter, an orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements; however, healthcare facilities that are in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority.

On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical device in hospitals, healthcare institutions or any related facilities.

An orphaned medical device is an existing medical device in a hospital, healthcare institution or any related facility that is not registered under Act 737 as it no longer has the manufacturer or authorized representative to register the medical device. Obsolete medical devices are outdated medical devices that are no longer used due to design changes or the evolution of new technologies etc. Discontinued medical devices are medical devices that are no longer distributed in the market or are no longer being produced.

According to the circular letter,
a) An orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements
b) Establishments or healthcare institutions in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority
c) The risk of using orphaned, obsolete and discontinued medical devices the responsibility of the establishment, users and healthcare institution
d) Establishments shall be responsible for post-market issues associated with any obsolete or discontinued medical device for the projected useful life of the medical device as determined by the manufacturer
e) Compliance is required with notification requirements as specified by the Authority

This circular letter shall be used as part of requirements under Act 737 and shall be effective from the date it is issued. The revised circular letter can be referred to here and the original circular letter released in 2018 can be referred to here.

2019-10-02T04:16:12+08:00 September 28th, 2019|Insight, Medical Regulation Updates, News & Events|

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

Halal

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

Halal

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

Halal

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|

Regulatory Affairs Professionals Society (RAPS) 2019 – Meet Andaman Medical at Booth #533

RAPS

This year’s Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence 2019 will be held in Philadelphia, Pennsylvania from 21st September until 24th September 2019. Do not miss this opportunity to speak to Andaman Medical representatives at Booth #533!

It is that time of the year again – we are thrilled to catch up with familiar faces and connect with new people at the RAPS Regulatory Convergence 2019. This event has helped the regulatory community to exchange information, expand networks, resolve regulatory challenges and more.

RAPS 2019 will be held in Philadelphia, Pennsylvania from 21st September until 24th September 2019. Do not miss this opportunity to speak to Andaman Medical representatives at Booth #533. We will be able to provide you with insights into regulatory strategy particularly in ASEAN countries such as Singapore, Malaysia, Indonesia, Thailand, the Philippines and Vietnam. This is the opportunity for all of us to network with the best regulatory professionals and get the most up-to-date industry knowledge.

For more information on RAPS 2019, visit their website HERE.

2019-09-01T12:56:58+08:00 August 30th, 2019|Event, Insight, News & Events|

The Philippines: FDA Aims to Implement the AO 2018-002: Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements in October 2019

Halal

At the recent ASEAN Medical Device Committee (AMDC) meeting in Manila, the FDA’s Center for Device Regulation, Radiation Health and Research (CDRRHR) Division Chief announced that Phase 0 of AO 2018-002 implementation will cover all registrable products in circular no. 2014-005, notification of class A medical devices and medical device listing.

The FDA’s CDRRHR Division Chief, Engr. Ma. Cecilia C. Matienzo, announced during the last AMDC meeting that they aim to implement the AO 2018-002 in October 2019. This will initially cover Phase 0, which includes the following:

  • All registrable products listed in the FDA Memorandum Circular No 2014-005: Updated List of Medical Devices required to be registered prior to sale, distribution and use, as well as its amendments
  • Notification of all class A medical devices
  • Medical device listing.

A checklist of requirements for the notification of Class A devices & medical device listing is provided below. For all registrable products listed in FDA Memorandum Circular 2014-005 and its amendment, the checklist of requirements shall follow the ASEAN Common Submission Dossier Template in accordance with the product’s risk classification (Class B, C, or D).

Annex A: Legal Requirements for the Application of a Certificate of Notification of Medical Devices under Class A and Registration of Medical Devices under Class B, C and D

1. Notarized Application Form
2. Payment
3. Copy of Letter of Authorization. For imported medical devices, the copy of the Letter of Authorization shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the authorization is true and correct.
4. A government-issued certificate attesting to the status of the manufacturer with regards to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485. For imported medical devices, the copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
5. For imported medical devices, the Certificate of Product Notification, Certificate of Product Registration, or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency or accredited notified body in the country of origin. The copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
6. Colored picture of the device from all sides. However, the CDRRHR can require a representative sample or commercial presentation for verification purposes.

Annex B: Technical Requirements for Application of Notification of Medical Devices under Class A
1. Device description consisting of the following:
a. Intended use
b. Instructions for use
c. List of all raw materials
d. Technical specification of the finished product
e. List of reference codes, sizes, colors, models and variance; whichever is applicable
2. Certificate of Conformity (issued by government agency dealing with metrology) on the aspect of manufacture relating to metrology for devices with measuring functions, if applicable
3. Declaration of Conformity (self declaration by the manufacturer) with product standards, if applicable
4. Clear and complete colored pictures of label from all sides of the packaging (loose label or illustrations of all layers of packaging)
5. Declaration of shelf life

Annex G: Requirements for the Application of Certificate of Medical Device Listing
1. Notarized Application Form
2. Notarized letter addressed to Director, Center for Device Regulation, Radiation Health, and Research, stating that the medical device will be used solely for research, analysis, or is being donated by a certain organization and is not intended for sale. The letter should contain the following information:
a. Complete list of the devices indicating the quantity, brand and the name of the manufacturer of the product
b. Declaration that the organization shall be the sole entity responsible for the medical devices and that the CDRRHR-FDA, Department of Health will not be held liable for any safety issue concerning the product
3. Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency in the country where the device will come from
4. For a donated medical device (brand new), a certified true copy of the deed of donation, the deed of acceptance, and the packing list or any document that will show the quantity of the product
5. Copy of SEC or DTI registration, when applicable

Moreover, it was also announced that the transition period will be 2 years and in this time it is expected that the FDA will issue further announcements and memorandum circulars in relation to applicable fees, validity of certificates, and product risk classification guidelines.

2019-09-01T13:40:24+08:00 August 28th, 2019|Event, Insight, Medical Regulation Updates, News & Events|

Thailand: Medical Device Risk Classification Tool and New Notifications from the Thai Food and Drug Administration (FDA)

Halal

The Thai FDA has made a classification tool available for the public to assess medical devices in accordance with the ASEAN Agreement on Medical Device Directives (AMDD). In addition, teeth whitening products and contact lens care products were recently announced to be regulated as medical devices in Thailand.

Currently, medical devices are classified according to the level of risk that may cause harm or impact on public health. The Thai FDA, under the Thai Ministry of Public Health (MOPH), regulates medical devices in Thailand. Medical devices are categorized into one of three classes: Class I (Licensed Medical Devices, highest class), Class II (Notification Medical Devices), and Class III (General Medical Devices).

Since Thailand has aligned with the ASEAN AMDD, the medical device risk classification will adhere to guidelines on risk classifications as outlined by the AMDD. Applicants can use this tool to identify the risk classification of a medical device and must select between in vitro diagnostic products and non-in vitro diagnostic products. Sometimes the medical device may overlap as a cosmetic or drug. Therefore, if there’s a new innovation, or the applicant wishes to ensure that a product can be classified as a medical device in Thailand, the applicant may request the Thai FDA to assess the product classification and risk classification. The applicant can access the Medical Devices Risk Classification Tool via the website here. However, the English version is not available on the website and the medical device risk classification is not final, and is available on the website awaiting feedback from importers and manufacturers.

Teeth whitening products are now regulated as medical devices in Thailand
The Notification of the Ministry of Public Health (No. 135) B.E. 2561 (2019) states that teeth whitening products with hydrogen peroxide concentrations higher than 6%, or carbamide peroxide or other agents with hydrogen peroxide present or released to 6% will be classified as Notified Medical Devices (moderate risk class medical devices). This announcement came into effect on 24 March 2019. Therefore, if an importer wishes to import dental whitening products into Thailand, they must identify whether the product is considered a cosmetic or medical device. Importers with the licence to import medical equipment including teeth whitening products can submit an application for notification to the Thai FDA. Sellers of teeth whitening products must submit an application for a license to sell medical devices, and are restricted to selling these products only to hospitals which are approved for dental practice under dental professional laws or to those licensed to sell medical devices.

Contact lens care products are now also classified as a medical device in Thailand
Coming into effect on the 26 October 2019, classifications for contact lens products have changed as specified in the Notification of the Ministry of Public Health (No. 136) B.E. 2562 (2019). Importers and manufacturers of contact lens care products need toregister this product with the Thai FDA as Notification Medical Devices. These products must also include labels and instructions for use in Thai as described by the Thai FDA.

Reference: Thai FDA Website

2019-09-01T13:29:10+08:00 August 28th, 2019|Insight, Medical Regulation Updates, News & Events|

Vietnam: Exemptions in Product Registration

Halal

There are several exempted requirements for product registration in Vietnam in accordance with circular 46/2017/TT-BYT. For instance, there are a number of imported devices that do not require clinical trial reports, as well as medical devices that can be traded as normal goods without the need for a Declaration of Eligibility to Trade

In addition to the decree 36/2016/ ND-CP and the newest decree 169/2018/ND-CP about medical device management, there are some circulars that relate to the full process of medical device registration in Vietnam.

For example, the circular 46/2017/TT-BYT includes the list of imported medical devices for which clinical trial datasheets and clinical trial results are not required when applying for registration.

Here is the list of medical device which do not require clinical trials/reports for registration:
1. Peritoneal dialysis catheter
2. Catheter
3. Catheter Kit
4. Cannulae
5. Guidewire
6. Introducer

In addition, it also provides a list of class B, C, and D medical devices that may be traded as normal goods without the submission of a Declaration of Eligibility to Trade.
1. Type B home-use in vitro diagnostic devices
2. Personal blood pressure monitors
3. Electronic thermometers, infrared thermometers
4. Personal blood glucose monitoring devices: blood glucose monitors, lancing devices, test strips, lancets, control solutions
5. Nebulizers
6. Adhesive bandages
7. Artificial tears classified as medical equipment
8. Condoms
9. Vaginal contraceptive films (drug-free)
10. Vaginal lubricants
11. Electric heat bags

As circulars or decrees are updated often, the registrant will need to keep up to date on any new notifications to understand current product registration protocols. This will allow the process to work smoothly and to obtain approval on time.

Each notification from the Circular or Decree should be updated any time. Upon the evaluation/combination, the registrant will right view for completely product registration. This will help the process will work smoothly and approval on time.

2019-09-01T13:30:55+08:00 August 28th, 2019|Insight, Medical Regulation Updates, News & Events|

Indonesia: Halal Certification

Halal

The Government of Indonesia issued Regulation No. 33 dated October 17, 2014, concerning the Halal Products Guarantee. Article 67 states that the obligation for halal certificates for products circulating and traded in the territory of Indonesia will come into effect 5 (five) years from the date the regulation was issued.

Indonesia is a country with the largest Muslim population in the world. Therefore, the Government are trying to guarantee that all products circulating in Indonesia are halal.

To support this, the Government of Indonesia issued Regulation No. 33 dated October 17, 2014, concerning the Halal Products Guarantee. Article 67 states that the obligation for halal certificates for products circulating and traded in the territory of Indonesia will come into effect 5 (five) years after the regulation was issued. Thus, the obligation to seek halal certification will come into effect on October 17, 2019.

On the 29 April 2019, the President of the Republic of Indonesia, Ir. Joko Widodo, set President Regulation, PP No. 31 of 2019 to initiate implementation of Regulation No. 33 of 2014 concerning the guarantee of halal products.

Products circulating in Indonesia that are required to have halal certification include food and beverage products, pharmaceutical drugs, cosmetics, chemical products, biological products, genetic engineering products, and goods that are used, or utilized. The items that can be utilized is Medical Devices. As for Goods that are required to be halal certified only those containing animal elements.

The application of halal certification for these products is carried out in stages with grace period for each. Medical devices are divided into 4 risk classes with the grace period as follows:

Risk Class A – 7 years (up to October 17, 2026)
Risk Class B – 10 years (up to October 17, 2029)
Risk Class C – 15 years (up to October 17, 2034)
Risk Class D – (set in President Regulation)

2019-08-02T17:11:46+08:00 July 31st, 2019|Insight, Medical Regulation Updates, News & Events|