Monthly Archives: October 2017

It is important to register your medical device with the Ministry of Health before the device can enter the Indonesian market. It is also important to check for other necessary registration requirements from other government bodies. For example, any medical device that uses wired or wireless technology operating at certain frequencies (such as built-in Bluetooth, wifi, 3G CAM feature) requires a telecommunication certificate and must be registered for certification at the Ministry of Telecommunication & Information of Indonesia. It is important for the government to regulate all electronic devices and to monitor frequency usage to ensure that new devices do not cause interference with existing medical equipment.

The Ministry will enlist this device for a scheduled field test at an appointed laboratory. A government fee has to be paid for this and it varies according to the type of features being tested. Although your device may have been tested in other countries, it is still required to have it tested locally in Indonesia to receive a telecommunication certificate. It is important that you dispatch a sample of the device with a built-in test mode to your local partner’s address prior to the test. The appointed laboratory must perform the test procedure; however, you may arrange for one of your technicians, or a technician from your local partner, to attend the field test. It is important to ensure that your local partner provides you with complete information to ensure that your medical device complies with all necessary regulations prior to importing the product into Indonesia.

The medical device registration process in Malaysia now involves a third party, the Conformity Assessment Body, that is responsible for the assessment of conformity of devices in Classes B, C, and D. Conformity Assessment Bodies are selected and licensed by the Medical Device Authority (MDA) to perform two types of assessment on medical devices: 1) via verification and 2) full conformity assessment, before the device can be submitted for registration.

The involvement of a third party in the registration process is uncommon in other countries where the application for device registration is submitted to the authority alone to be processed for conformity assessment. Involvement of the third party in the process lengthens the time required to achieve device approval. Due to the high demand of applicants, conformity assessment in Malaysia takes, on average, 2 months, sometimes longer. Once conformity assessment is complete, applicants can proceed with registration submission to the MDA with the following targeted timeline: Class B 100 days, Class C 180 days and Class D 220 days.

There are 17 approved and licensed CABs for applicants to choose from and each of them has a specific scope or expertise in particular technical areas. Therefore, it is important that applicants confirm that their chosen CAB covers the scope of their device before selecting them. Recently, the MDA released a Guidance Document on the ‘Conformity Assessment of Medical Devices’, numbered as MDA/GD/0031. This document provides guidance to applicants and CAB to understand the assessment elements that are tabulated clearly in the document.

Applicants are advised not to delay their engagement with their chosen CAB or registration submission to the MDA because the new registration requirements will be fully implemented by 31st December 2017. Refer to our previous article regarding the implementation of the new registration requirements here.

From 01 July, 2016, the new decree 36/2016/NĐ-CP on Medical Device Management came into effect and it is predicted that these new medical device regulations will have an impact, not only on product registration, but also on trading, importation, manufacturing and market circulation in Vietnam.

An important change in the new medical device regulations is that medical devices are now classified based on a risk classification (group A, B, C, D), rather than function classes (equipment for operation, sterile devices, equipment for anesthesia, etc) as before. Class A medical devices will be managed by the local health department and the product license remains permanently valid. Class B, C and D medical devices will be managed by the Department of Medical Equipment and Construction, Ministry of Health (MOH) of Vietnam. Product licenses will be valid for 5 years from the date of issue. The MOH of Vietnam also issued a guideline for medical device classification and recognition of classification results from the US-FDA, EU, TGA (Australia), Canada, Japan, Korea and the ASEAN region.

Previously, according to the circular 30/2015/TT-BYT on Importation of Medical Devices, there were only 49 types of medical device that required an import license. Devices that were excluded from the list could be freely imported. The new medical device regulations will prevent this situation and the perceived inequalities between domestic and imported goods.

2017 is the transitional year for the phasing out of the old regulations and the implementation of the new regulations. With the new product license, medical devices can be imported or exported with no limits on quantities. From 01 July, 2017 to 31 December, 2017, Class A medical devices are only allowed to be imported with a notification receipt from the local Department of Health. The importer is required to submit the classification result and letter of authorization of the license holder (if the importer is not the product holder). Class B, C and D medical devices that appear on the importation list (in circular 30/2015/TT-BYT) will need to have an import license and classification result to be imported. For those devices excluded from the list, the importer has to show the classification result when importing the products. From 01 January, 2018, Class B, C, and D medical devices will be required to have a registration number for importation. IVDs that have a registration number approved before 31 December 2017, can continue to be imported until the expiry date of the license.

The Health 2.0 11th Annual Fall Conference was held on October 1st – 4th 2017 in Santa Clara, California. The aim of the conference was to introduce and showcase new technological developments in the healthcare sector. Innovative ideas and products addressed a variety of health situations including sleep enhancement, addiction, voice-recognition mobile phone apps linking doctors and patients, 3-D scanners, and other self-help medical devices.

Sleep aid medical device technology figured strongly in the conference with products claiming to enhance sleep by various means including sound modulation within the room, more traditional white-noise generators, new mattress technology with an in-built cooling facility or a smart pillow that detects and guides sleep behaviour. Other innovations included sunglasses incorporating a monitor to tackle addiction, eating disorders and trauma. At the medical centre itself, new technology can monitor incoming calls and access patient details in advance of the consultation, as well as interlinking and coordinating medical service providers to ensure maximum benefit to the patient. A prescription management platform can ensure the patient accesses the right medication at the right time and the poly-pharmacy management dashboard reduces hospital visits and emergency service time. Diagnostic systems for endometriosis and skin cancer similarly serve both patient and health service provider. Medical alert sensors and pre-diagnostic triage tools were also showcased.

With a view on future developments and the latest innovations in healthcare technologies, the conference resolved to understand how the solutions demonstrated could be applied to alleviate troublesome healthcare problems in South East Asia by focussing on responding to the demands of the market.