Special Access Routes in Indonesia and the Philippines – live webinar

OSCAR system

Join us for the second webinar in our series “Medical Device Regulatory Special Access Routes”. After having taken an indepth look at Malaysia and Singapore in the first webinar, this time we will be focussing on Indonesia and the Philippines. Register today!

Register today for our live webinar on Medical Device Regulatory Special Access Routes for Indonesia and the Philippines

This webinar is the second in a series on ASEAN markets. This webinar has been created to provide you with a clearer picture on how to navigate the expedited access pathways to register, import and distribute medical devices during the COVID-19 outbreak and beyond.

In this webinar, you will gain knowledge of the following:
– Overview of current situation in Indonesia and the Philippines
– What are the Special Access Routes (SAR) available versus standard registration?
– Which medical devices are included in Special Access Routes?
– Who can import?
– Overview of the Special Access Routesprocedures
– Timeframes to market
– Distribution routes for your medical devices
– Question and Answer session

Our presenters:
– Femilia Aulina, Regulatory Affairs Specialist, Indonesia
– Melody Quebec, Regulatory Affairs Specialist, Philippines

Register today! 

This second edition follows on from our highly successful first webinar which was held live on Tuesday 21st April 2020 and covered the Special Access Routes for medical devices in both Malaysia and Singapore. Some comments from participants:

“I would like to congratulate you for the success of the webinar. Well done guy and gals.  It really helps our company to make subsequent marketing development plan amid this crisis.” 

“Thank you Andaman for organising a very useful session for SAR into Singapore and Malaysia”. 

We will be hosting a final live webinar covering the same topic for Thailand and Vietnam later in May 2020. You can request the webinar recording for Malaysia and Singapore as well as request to sign up in advance for the final webinar on Thailand and Vietnam by emailing victoria@andamanmed.com 

And don’t forget that we also offer personalised training as well as online training courses . Send us an email us to find out more.

2020-04-30T18:38:55+08:00 April 30th, 2020|Event, Insight, Medical Regulation Updates, News & Events|

Vietnam produced covid-19 Test Kit and Regulation for the Importation of Test Kits during the pandemic

covid-19

Scientists in Vietnam have successfully manufactured an in vitro (kit) real-time RT-PCR to detect novel coronavirus (SARS-CoV-2), which has been shown to deliver highly accurate results within 1 hour

On 5th March, The Ministry of Science and Technology announced that scientists in Vietnam had successfully manufactured an in vitro (kit) real-time RT-PCR to detect novel coronavirus (SARS-CoV-2), which was shown to be highly accurate with result within 1 hour. Vietnam could manufacture 10,000 kits per day with productivity reaching three times that if required.

The manufacturing process strictly follows quality requirements for medical device manufacturing, ISO 13485. The testing laboratory also follows ISO Class 8. The kit has been tested for its accuracy, sensibility, specificity, repeatability and compared with the kit provided by the US CDC and WHO. The Ministry of Health released Decision no. 774/QĐ-BYT to circulate the list of 02 IVD products for detection of SARS-CoV-2 in Vietnam. The productivity could serve the domestic requirement and production by order for sponsorship of many other countries. Vietnam has become one of the few countries that can produce the test kit, alongside the WHO, Japan, Germany and China.

The Ministry of Health also issued the dispatch no 1592/BYT-TB-CT regarding the manufacturing and importation of the SARS-CoV-2 test kit in which, the MOH encourages companies, importers and manufacturers to manufacture and import medical devices and IVD products related to the detection of SAR-CoV-2. For test kits used for sponsorship or donation, the import license could be approved through a special route: medical devices for sponsorship, aiding and donation, according to Decree 169/2018/ND-CP. For test kits to be used with medical devices, without sponsorship or donation, it is required that they have an import license according to Circular 30/2015/TT-BYT. For independent test kits (IVDs), it is required to have importation permission in accordance with Circular 47/2010/TT-BYT on the Import and Export of Pharmaceutical Products and Packaging Directly Connected With Pharmaceutical Products, IVDs part.

2020-05-01T06:02:02+08:00 March 31st, 2020|Event, Insight, News & Events|

COVID-19 update from Andaman Medical

advertising

Some health ministries in the ASEAN region have shut down their operations to help mitigate the spread of COVID-19; therefore, it is likely that there will be a delay in the processing of medical device registrations over the coming months. We are monitoring the situation closely as it evolves and continue to operate as usual; however, some delays are to be expected..

Dear partners,

As you will no doubt be aware, the novel coronavirus (COVID-19) pandemic continues to have an impact around the world.

As a direct result, some health ministries in the ASEAN region have shut down their operations to help mitigate the spread of COVID-19; therefore, it is likely that there will be a delay in the assessment and processing of medical device and in-vitro diagnostic product registration applications over the coming months. At Andaman Medical, we are monitoring the situation closely as it evolves and continue to operate as usual; however, some delays are to be expected.

In line with local health advice and to ensure the safety and health of our staff, we have also implemented a working-from-home policy for the coming weeks. Please rest assured that all staff members have the tools they need to be able to work efficiently from home. In addition, all internal and external meetings can now be conducted via our new video conferencing system.

We would like to take this opportunity to offer you our support during these challenging times. Should you have any queries regarding regulatory requirements in the ASEAN region, please do not hesitate to get in contact with our team at contact@andamanmed.com

Thank you and stay safe!

2020-03-20T20:35:55+08:00 March 20th, 2020|Event, News & Events|

Overview of the e-Catalogue in Indonesia

advertising

The use of the e-Catalogue in Indonesia makes the procurement of goods/services in the public sector more efficient. Shorter procurement times and fair competition partners ensure the government is getting the best price.

The Electronic Catalogue (e-Catalogue) is an electronic information system that lists the technical specifications and prices of certain goods and services from various providers. The e-Catalogue was created by the Government Goods/Services Procurement Policy Agency, Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah (LKPP), at the end of 2012.

Some of the benefits of using the e-Catalogue are:

  1. It makes the process of procurement of goods/services in the public sector more efficient. Shorter procurement times and competition partners ensure the government is getting the best price.
  2. The e-Catalogue also increases transparency. This can supress the problem of budget leakage that often occurs in the procurement of goods/services.
  3. It simplifies the process, making it more inviting for partners to participate.

An e-Catalogue of medical devices has been promoted since 2015. The next opening date for procurement of the medical devices e-catalogue is yet to be announced. The LKPP will announce it on their website (http://lkpp.go.id).

Once announced, the LKPP will aim to inform all those medical device distributors who may want to join the e-Catalogue. LKPP will then issue an invitation to all registered companies to meet. At the meeting, the LKPP will explain the procedures for the opening bid schedule and any requirements. All information shared by the LKPP will be available in the bid document. This is normally shared on the LKPP website and can be downloaded.

Documentation required by the LKPP:
1. Offering Letter
2. Qualification Form
– Deed of establishment
– Latest amendment to the deed of establishment (if any)
– Business License Number (NIB)
– Tax ID number
– Latest annual tax notification (typically LKPP will mention the latest year that can be used)
– Medical Device Distribution Certificate (referred to as IPAK)
– Letter of Authorization with Principle/Manufacturer
3. Integrity Pact
4. Technical Bid Documents
– Technical specification of the product
– Statement letter of product warranty (at least one year).
– Statement letter of guaranteed availability of spare parts for at least 5 years.
– Registration Certificate issued by Ministry of Trade (referred to as Surat Tanda Pendaftaran or STP)
– Approval License issued by Ministry of Health
5. Bidding Documents
– A price list of government and non-government offers for each product
– Bid price in Indonesian Rupiah (IDR)
– Imported products must include the most recent Goods Import Declaration (called the PIB) and the item purchase invoice.

The LKPP values those bids that provide:
1. Evaluation and proof of qualifications
2. Administrative evaluation
3. Technical evaluation
4. Negotiation

The LKPP will seek further clarification from those who have submitted all the required documentation. They will also check copy documents against the original hardcopy. If complete and eligible, the LKPP will invite eligible producers into a negotiation on product price.

The LKPP will issue a contract of catalogue to those successful in negotiations. This is a co-operation agreement signed by the LKPP and the provider for inclusion of goods/services in an e-Catalogue for two years. After receiving the contract of catalogue, providers can submit the agreed upon product into the e-catalogue system: http://e-katalog.lkpp.go.id/

2020-03-02T03:26:18+08:00 February 27th, 2020|Event, Insight, News & Events|

Vietnam: Import Duty Exemption for Selected Medical Devices Amid COVID-19 Outbreak

advertising

The Ministry of Finance have assigned the General Department of Customs to direct and guide customs units to implement the tax exemption policy for imported goods in order to prevent and control the Covid-19 epidemic.

The Minister of Finance, Mr. Dinh Tien Dung, has announced a tax exemption on imports of five commodity groups that are needed to fight the novel coronavirus. On February 7th 2020, authorities signed Decision 155/QĐ-BTC allowing import tax exemptions on medical masks, hand sanitizer, mask materials, disinfectant and protective clothing.

The Ministry of Finance (MoF) has assigned the General Department of Customs to direct and guide customs units to implement the tax exemption policy for imported goods to prevent and control the epidemic. Customs offices will carry out customs clearance for goods in the groups and will also work with relevant agencies to inspect and ensure importation is for the correct purposes.

The groups of goods subject to exemption include:
– Medical masks with international harmonized system (HS) codes* of 6307.90.40 and 6307.90.90.
– Disinfectant gel or liquid hand sanitizer with HS code 3808.94.90.
– Mask materials include non-woven fabrics and antibacterial filters; elastic bands with the regulated HS codes.
– Disinfectants with HS codes of 3808.94.20 and 3808.94.90.
– Protective clothing including trousers, shirts, goggles, medical masks, helmets, gloves and shoes with HS code 6210.10.90.

This decision took effect from February 7th 2020 until the end of the epidemic.
*HS code stands for the Harmonized System code describing the type of goods

2020-03-02T03:29:16+08:00 February 26th, 2020|Event, Insight, News & Events|

COVID-19 Impact on the Medical Industry and Measures by Health Science Authority, Singapore

advertising

In order to deal with the current ‘’out of stock’’ and overly inflated prices of surgical masks, hand sanitisers, respirators, thermometers and protective gear due to the COVID-19 outbreak, the HSA in Singapore has put measures in place by restricting import of these ‘’high in demand commodities’’

In recent times, one of the most talked about topics in the world is the rise of the novel coronavirus strain, officially named COVID-19. The virus is severely contagious and is having a worldwide impact.

It is not easy to miss the snaking queues at pharmacies for surgical masks, sanitisers, protective clothing and pretty much anything else that claims to have antiseptic & antibacterial properties. Pharmaceutical companies are also making a lot more money by selling immune boosting supplements and flu medications. People are being overly conscious and cautious with flu like symptoms, especially in those countries with a greater presence of positive COVID-19 cases.

Medical device companies are experiencing increased sales by catering to the need for diagnostic kits, protective clothing, gloves, testing equipment, x-ray machines etc. Although the medical and pharmaceutical device industries are experiencing increased sales, they are also providing funds for research into the cure and treatment of the virus.

In order to deal with the current ‘’out of stock’’ labels and overly inflated prices of surgical masks, hand sanitisers, respirators, thermometers and protective gear, the HSA has put measures in place by restricting the import of these ‘’high demand commodities’’ for personal use beyond certain quantities. In an attempt to tackle the risk of substandard products in the Singapore market, they have also implemented easier importation options for dealers by forgoing the need for an ‘’Importer’s License by the HSA’’. During this time, importers only need to notify an intention to import to the authority. They also need to provide information regarding the brand and quantity of devices that are to be imported into Singapore. It is expected that they maintain proper sales and distribution records. These records will later be subject to submission to the HSA.

2020-03-02T03:37:50+08:00 February 26th, 2020|Event, Insight, News & Events|

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

conference

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

conference

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

conference

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|