The dependency of the Conformity Assessment Body in Malaysia on Notified Bodies in EC

Malaysia recognizes CE marked devices by permitting medical device registration via an abridged evaluation instead of a full conformity assessment. With the stringent new EU Medical Device and In Vitro Diagnostics Regulations, what will happen to existing approved registrations in Malaysia when the notified body in Europe and EC Certifications are no longer valid?

The Notified Bodies in Europe and the Conformity Assessment Body in Malaysia assess the conformity of medical devices before they are placed in the market for public or professional use. Comparing these two bodies may not be a straightforward ‘apple to apple’ comparison due to differences in the scope of their work. However, it is worth understanding their similarities and differences on the regulatory platform.

What are they and what do they do?
A Notified Body in Europe is an organisation that has been designated by an EU member state, EC (European Community) and functions to assess the conformance of a medical device according to EU legislation. After several assessments have been completed on products and manufacturers, the Notified Body will permit manufacturers to place CE marks on their products and subsequently allow them to be marketed anywhere in Europe.

A Conformity Assessment Body is a body appointed by the Malaysia Medical Device Authority to perform two types of assessment on products: abridged assessments or full conformity assessments. The former is for devices that have already obtained approvals from recognised countries such as Europe (CE mark), the US FDA, Health Canada, TGA Australia or the Japan MHLW. The latter follows a similar process to obtaining a CE mark in Europe and is more thorough and lengthy in scrutinising reports and documentation. The updated list of registered Conformity Assessment Bodies with the Malaysia Medical Device Authority can be found on the Malaysia Medical Device Authority website.

The Dependency on an EU Notified Body
CE marks granted by a Notified Body in Europe (EC) are a good benchmark for many developing countries to allow the CE-marked products to be placed in their market, as there is a level of confidence in the safety and effectiveness of the devices. The same scenario is applied in Malaysia as the authority recognizes CE-marked devices by permitting registration via an abridged evaluation instead of a full conformity assessment. The Conformity Assessment Body assesses the device in accordance with the validity of the Notified Body via the NANDO database, validity of certification, and a few other requirements. In the case where certification by an Notified Body in Europe is no longer valid, the Conformity Assessment Body in Malaysia is unable to grant certification for the device for product registration purposes, unless the device has other approvals, for example, by the the US FDA, TGA Australia, Health Canada or the Japan MHLW. This situation portrays the clear dependency of the Conformity Assessment Body in Malaysia on Notified Bodies in Europe.

Foreseeing Challenges
Europe is an established medical device market with manufacturers commonly wanting CE marks on their devices. However, the Notified Body system has been constantly criticized for its lack of uniformity in certification procedures, varying levels of expertise across the Notified Bodies, and the questionable assessment of Notified Bodies on silicone gel breast implants in early 2010, which led to fears of a massive health disaster. This has prompted the publication of new Medical Device Regulations with stricter requirements on the surveillance of Notified Bodies in Europe. The new EU Medical Device Regulations and In-Vitro Diagnostics Regulations come into force at the end of May 2017, with full implementation taking effect by May 2020 and May 2022, respectively. Our previous post included the regulations for your reference.

Clearly, there will be a direct impact on product registration in Malaysia. Currently, the number of Notified Bodies in Europe is only declining and the trend is expected to persist, due to the tougher requirements imposed by the EU Commission. Apart from some changes to medical device requirements, the IVD regulations witnessed a much greater change as the regulations are likely to result in 80% of IVDs requiring a conformity assessment by a Notified Body compared with only 20% requiring conformity assessments within the previous directives.

As of today, the Malaysia Medical Device Authority had not made any announcement or notification regarding any change to the conformity assessment process in Malaysia. The circular letter No. 2 year 2014 revision 2 , which became effective on the 20th January 2017 still refers to the EU Medical Device Directive. According to this circular letter, only IVD devices that fall under Annex III, with an EC declaration of conformity (Section 1 to 5 of Annex III), which is applicable to only Class B IVD medical devices in accordance with Medical Device Regulations 2012, can be assessed via abridged evaluation. With the new EU regulations, this type of device may require conformity assessment in the EU instead of self-declaration by the manufacturer only, therefore the declaration of conformity alone is no longer sufficient for a manufacturer to comply and place a device in the market. So, does this mean that the approved registration in Malaysia that solely depends on the manufacturer’s declaration conformity is invalid? What are the actions to be taken by the Malaysia Medical Device Authority to address the gap associated with the change in Europe’s medical device regulations that clearly has an impact on Malaysian registrations too? Whatever happens, we hoped for a staggered implementation so that the industry can anticipate the change and have a manufacturing and marketing strategy in place to cater to any changes accordingly.

2018-01-08T17:49:10+08:00 May 29th, 2017|News & Events|

Checklist for Medical Device Registration in Indonesia

Do you have the essential documents ready for registration? Here’s a checklist to minimize the time spent on preparing for medical device registration in Indonesia.

If conducted poorly, the medical device registration process in Indonesia can become an inevitably long journey. We will describe some of the key challenges faced during the medical device registration process in Indonesia. Careful planning by product owners will help keep the medical device registration process on schedule.

1. Is your medical device registration dossier ready?
For most cases, document completion is the key to a successful medical device registration. It is important to prepare the dossier carefully and accurately prior to submission in order to avoid additional queries from evaluators and any delays in the process.

2. Has the Letter of Authorization been legalized?
Legalizing the Letter of Authorization by the Indonesian consular located within the product’s country of origin is mandatory. Where the applicant is not the product owner, provide a detailed explanation to the embassy officer.

3. Has your medical device been registered within IMDRF countries?
Having the medical device registered in IMDRF-member countries, especially the USA (US FDA), can be counted as an advantage to speed up the registration process in Indonesia.

4. Has your medical device been registered in its country of origin?
It is important that the Certificate of Free Sales (CFS) is issued from the health authority of the product’s country of origin. If this is not applicable to your case, additional time may be required to discuss this with the evaluators.

5. Is your medical device obligated to have another license?
Review the specification of your product and the requirements in other countries. For example, a medical device that uses radio frequency is obligated to acquire a “certificate for a telecommunication instrument” issued by the Ministry of Communication and Information Technology.

6. Have you chosen the right partner?
It is essential to choose an excellent local agent, who is an expert in medical device registration, and is willing to invest time to keep the communication flowing. Even after successfully obtaining marketing approval, the right partner should be able to assist you in distribution, quality management, and post-marketing surveillance.

2018-01-08T17:49:54+08:00 May 29th, 2017|News & Events|

The Thailand FDA Intensifies MD Reporting Requirements

The Ministry of Public Health published the criteria, methods, and conditions for submitting adverse events reports. This came into effect in November 2016. In addition, the risk levels that trigger report obligations, the deadlines for submitting reports, and the fines imposed on those who fail to comply were specified.

Background
Thailand’s Food and Drug Administration (TFDA) oversees the safety and quality of consumable products including medical devices and pharmaceutical drugs within the country. The “Medical Device Act, B.E. 2551 (2008)” is the national legislation pertaining to medical devices.

Under this legislation, Business Operators or Medical Device Establishments have an obligation to prepare and submit reports to the Health Authority on any adverse events or malfunctions related to medical devices that they manufacture, import or sell. This is specifically stated under the Medical Device Establishments’ Responsibilities – Section 41-4, “Prepare report on performance abnormality or any adverse reactions of the medical device, and report on its correction to the licensor, whether it happened in the country or abroad, however, [the report] shall be made in accordance with the rules, procedures and conditions prescribed by the Minister”.

Furthermore, the Ministry of Public Health Notification published the criteria, methods and conditions for submitting the reports, which came into effect in November 2016. This Notification is designed to provide an optimal safety monitoring program with regard to the usage of medical devices, similar to what is required for pharmaceutical drugs. The matters covered include: the risk levels that trigger the reporting obligations, the deadlines for submitting adverse event reports, and the fines and/or imprisonment terms imposed on those who fail to comply. These new standards are inline with the ASEAN and Western international standards, and in order to ensure compliance, the TFDA conducts random post-marketing audits of local establishments.

In addition to this Notification, the TFDA has introduced an online reporting system – “Medical Device Problem Reporting” – which is accessible via a webpage. This will streamline the reporting process and will enable stakeholders to file or submit a report online using the TFDA’s established format.

Looking Forward:
In the past, monitoring adverse events was a laborious process lacking in timely data. In an effort to continuously improve health outcomes, the healthcare industry gradually evolved to meet changing regulations and make the most of new technologies. As such, this Notification and the online reporting system, will strengthen the pharmacovigilance functions of the medical device sector. Likewise, these will effectively allow the TFDA to appropriately manage medical device risks to ensure consumer and public health safety in general. Moving forward, companies must not only monitor adverse events, but also proactively assess and manage medical device risk throughout its lifecycle.

2018-01-08T17:51:05+08:00 May 29th, 2017|News & Events|

The China FDA Issues Provisions for “Medical Device Standards”

The Provisions for Medical Device Standards were adopted at the executive meeting of the China Food and Drug Administration on February 21, 2017, and will come into effect on July 1, 2017.

In order to set a standard for medical devices, the China Food and Drug Administration (CFDA) has formulated the Provisions for Medical Device Standards. The Provisions for Medical Device Standards was adopted at the executive meeting of the China Food and Drug Administration on February 21, 2017, and will come into effect on July 1, 2017.

All manufactured medical devices will need to comply with the national standard, or professional standards. Both standards will be created by the collaboration of the Authority and State Council. Furthermore, the instructions for use, label, and packaging of medical devices will need to comply with relevant standards or provisions in China.

The publication of the Provisions for Medical Device Standards will play a positive role in guiding China’s standardized management of medical devices; regulating the formulation and revision of standards; promoting the implementation and improvement of standards; and, improving the quality of medical devices.

The complete regulation for the “Supervision and Administration of Medical Devices” can be found here.

2018-01-08T18:02:59+08:00 May 29th, 2017|News & Events|