Regulatory Updates – September 2021

Welcome to the Arazy Group Medical Device Regulatory Update! Today’s update is from Saudi Arabia. Here is a quick summary of our update:
The first update is that a new risk classification system is set to eliminate the GHTF route to obtain MDMA. This update has been implemented since July 2nd, 2021.
The second update is the implementation of the new online registration system. This update has been implemented as of July 2nd, 2021.
The third update is the UDI system implementation. This update will be implemented by September 1st, 2022 for class B, C and D.
The last update is the fee for updating Medical Device Marketing Authorization applications. This update has been implemented as of January 13th, 2021.
Now let's talk about each update in detail.

In December 2019, through announcement 11, SFDA announced that the manufacturers may continue to use the GHTF route until March 31st, 2021.
However in July 2020, through announcement 1, SFDA allowed the manufacturer to use the GHTF route until January 1st, 2021.
In July 2021, the Saudi route was introduced. Now new applications must begin by using the Saudi route. The submission of a technical file is also required as part of the MDMA application. The GHTF route however, is still accepted for renewal and amendment applications. The MDMA certificate that was issued using the GHTF route will be valid until its expiration date.
By January 2022, all applications must use the Saudi route.

In October 2019, the new online registration system was introduced. Previously, the applicant was required to use a separate system to apply for MDMA, MDNR, and any other applications. In this new system, there will only be one system for multiple applications.
the manufacturer can still access the old system until January 2020. As of July 2021, the new online registration system has been fully implemented; therefore, all applications in the old system will be cancelled and all applicants must use the new system.

When the UDI system is implemented, the UDI information must first be indicated on the device's primary label. Secondly, it must be provided along with the MDMA application. And lastly, it must be submitted to the Saudi UDI database before the product is placed on the market.
The implementation of the UDI system will be done in phases. For class B, C, and D, the UDI must be implemented by September 1st, 2022. Whereas for class A, the UDI must be implemented by September 1st, 2023.

If you are looking to register your products in Saudi Arabia, consider LICENSALE, our Global MedTech Registration system for fast and easy market access.

The registration fee that is applicable for license amendment has been updated from previously being only one flat fee for all types of changes, into various fees depending on type of change.

The technical file that must be submitted during the MDMA application must contain at least the following information: device description and specification, label, instruction for use, promotional material, design and manufacturing information, essential principle, benefit risk analysis and risk management, product verification and validation, post market surveillance plan, periodic safety update report, and post market surveillance report.

That's it for our update today! If you have any comments or questions, please do not hesitate to email, or call us. Check the contact us page on our website for an Arazy Group office near you.
Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.

Welcome to the Arazy Group’s regulatory update. Today’s update is from Thailand.
Today we will cover the regulatory updates that were introduced in December 2019 but were only enforced on February 15, 2021, for Class 2, 3, and 4 and on March 15 for class 1 devices.
New product classification and grouping, New registration fees and timeline, and new registration procedures.
Let's review each update in detail.

Product risk classification. Before December 2019, medical devices and IVD were classified into 3 risk categories: a general medical device for high-risk products, notified medical device for medium-risk products, and a licensed medical device for low-risk products.
Since February 2021, medical devices and IVDs are classified into 4 risk categories; Class one for low-risk products, Class 2 for low to moderate-risk products, class 3 for moderate to high-risk products, and class 4 for high-risk products.

The new product grouping will allow all product classification to be grouped as either a family, a system, a set, an IVD test kit, or an IVD cluster. The devices are grouped based on the following criteria:
they have the same generic proprietary and/or product name, they are sold under a single brand name (meant to be used together as a system), they are intended to be used in combination to achieve a common intended purpose, they are all under the same legal manufacturer, and they are compatible when used together as a system.

If you are looking to register your products in Thailand, consider LICENSALE, our Global MedTech Registration system for fast, and easy market access.

The fees for the registration have increased almost 3 times from previous fees for all product classifications. The review and registration timeline remains the same for classes 2, 3, and 4, and is extended for class 1 devices from a maximum of 60 days to 200 days.
In the old registration procedure, there were 2 registration pathways; For general medical devices, the applicant was only required to conduct CFS verification. While for notified and licensed medical devices, the applicant was required to submit a hard copy of the full dossier manually to the Thai FDA.
In the new registration, there is only 1 registration pathway for all product classification. This new pathway consists of 2 stages, pre-submission, and submission.

All applications are to be made through an online registration system. In the Pre-submission stage, the authority verifies the product risk classification and grouping. In the Submission stage, the authority reviews the technical documents.
Starting Feb 15, 2021, the Thai FDA provided 3 years to implement the new regulatory system. Thai FDA introduced transitional registration schemes: Partial registration and full registration. All existing registered products must be re-registered with the Thai FDA using the Partial Registration Scheme. Under this scheme, some compliance documentation (CSDT) will be waived. However, all new products must undergo full Registration, where complete technical documentation (CSDT) is required.

That’s our update for today. If you have any comments or questions please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.

Welcome to the Arazy Group Medical Device Regulatory Update! Today’s update is from the Philippines. we will cover the update on the classification and list of medical devices that are required to be registered in January 2021. A Draft on the List of Class A, Medical Devices, for FDA registration, in the Philippines. An update on the implementation of a new regulatory framework in January 2021. An update on the transition period to import non-registrable medical devices in August 2021. The automatic 4-months extension for registration certificates, until public health emergency is lifted. Let’s review each update in detail.

According to the FDA Circular Number 2020-001, there are 137 product categories listed as registrable medical devices. However, through the new FDA Circular Number, 2021-001A, the product risk for 31 product categories from the previous list are re-classified and the resuscitator and ventilator product categories are also added.
Under the previous regulation, there was only one list to cover all product risk classification. This list had been updated from time to time, and last updated through the FDA Circular Number 2021-001A. However, there is no specific list for Class A medical devices. Under the new draft regulation, in addition to the previous list, there will be a specific list for class A devices that are subject to CMDN. If for some reason, a product is not included in the list, then the classification shall be based on its intended use and the classification rules of the ASEAN Medical Device Directive. The FDA however, will verify the classification proposed by the applicant, and reclassify if necessary.

If you are looking for the best way to manage your product registration in the Philippines, consider REGISLATE, our Global Registration Management Software for fast and effective market access processes!

There are some Class B, C, and D products that are not included in the FDA Circular Number 2020-001. Such products are exempted from product registration and are considered as non-registrable. Although it is exempted, a certificate of exemption must be obtained in order to import and participate in a government bidding.
However, according to the FDA Circular Number 2021-002, non registrable products must now apply for CMDN, which is the registration procedure for class A registrable medical devices. The issued registration certificate will be valid for 2 years and must be converted to CMDR during the renewal process. However, the classification for non-registrable medical devices will follow the classification rules set by ASEAN Medical Device Directive.

To provide enough time for the industry to implement the new regulatory framework, the Philippines FDA has provided a transition period, wherein the companies may be allowed to import non-registrable medical devices and submit their CMDN application. Until March 31 2022, The importation of Class B, C, and D products without CMDN is still allowed. The FDA will start receiving the application for CMDN and the Certificate of Exemption will remain valid.
As of April 1st 2022, the importation of class B, C and D products without CMDN is still allowed, but with a condition that the CMDN application has been submitted. At this point, the certificate of exemption is no longer valid for the importation. By April 1st 2023, the FDA will stop receiving the CMDN applications and start receiving the C M D R applications. At this point, CMDN for Class B, C and D must be converted to CMDR. Therefore, more complex documents will be required for the registration. Moreover, Importation without approved CMDN will not be allowed.

To provide flexibility for the industry during the public health emergency period, registration certificates expiring between July and December 2021 will be granted an automatic 4-months extension. Under this new policy, the renewal application must be submitted within the 4 months extension. Failure to submit the application within the indicated time period will cause the applicant an additional charge. The extension however, will only be granted once.

That's it for our update today! If you have any comments or questions, please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.

Welcome to the Arazy Group Medical Device Regulatory Update! Today’s update is from Vietnam and the topics include: the update on the vietnam regulatory framework through a new decree that was issued in March 2021, but will only be enforced in October 2021. The transition period of a new regulatory framework that will be fully implemented in January 2023. The update on fast track registration procedure, and lastly, the implementation of ASEAN common submission dossier template in January 2022.
Let’s review each update in detail.

The medical device regulatory framework in Vietnam is currently under a transition process. It started with the Circular 30 that was issued in 2015. Under this circular, product registration is not required, except for certain categories that are listed in the Circular. In 2016, decree 36 was issued and all devices became subject to product registration, notification for class A, and marketing authorization for Class B, C, and D. Following the issuance of Decree 36, some existing IVD products that were previously regulated by the Drug administration of vietnam will be regulated by the department of medical equipment and construction instead.
In 2018, decree 169 was issued to amend Decree 36. Under this Decree, foreign medical device classification is no longer recognized. and so local official classification became a mandatory part of the product registration process. This classification process will be conducted by a third party and the Vietnamese translation of instruction for use will be required.
In 2020, Decree 3 was issued to amend both Decree 36 and one sixty nine. This decree stipulated that licenses issued before January 2022 will be valid only until December 2021, and ASEAN common submission dossier template will be fully implemented from January 2022.
In March 2021, a new draft was issued to unify all previous decrees. This Decree influences not only the update on the transition period for the implementation of decree 36 and 169, but also some technical details such as: the new classification rule, the registration pathway for medical devices used in an emergency situation or for individual purposes, and also fast track registration procedure. This draft will be fully implemented in October 2021.

To provide flexibility to the stakeholder in implementing a new regulatory framework, there have been some updates in the requirements. Licenses that are issued before the implementation of decree 36 and 169 will remain valid until the 31st of December 2022. The authority will require the ASEAN common submission dossier template to be submitted as part of the registration requirement starting from January 2022. While Decree 36 and one sixty nine will be fully implemented by January 2023.

If you are looking for the best way to manage your product registration in Vietnam, consider REGISLATE, our Global Registration Management Software for fast and effective market access processes!

Previously, the only 2 criteria to be eligible for fast-track registration procedure were that products had been approved in at least 2 reference countries, and products had been circulated for at least 3 years within 5 years from the date of filing in Vietnam, and there was no warning regarding the quality and safety during this period. Reference countries include Japan, Canada, Australia, USA, EU members, and now also include UK and Switzerland.

Under the new decree however, 2 more criteria have been added: Products have been approved and actively marketed in at least 2 reference countries, and products are meeting urgent needs for national defense, security, epidemic prevention and control, and overcoming consequences of natural disasters and catastrophes, or having no substitutes available on the market. This procedure is applicable for any risk classification so long as meeting 1 out of 4 criteria. In most cases, the first criteria is the most commonly chosen by the applicant.

This is the structure of ASEAN Common Submission Dossier Template. It is recommended to use Vietnamese as the language for submitting CSDT. However, certain sections and or or information can also be submitted either in English or Vietnamese.

That's it for our update today! If you have any comments or questions, please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.

Welcome to the uh rahzy Group Medical Device Regulatory Update! Today’s update is from Taiwan, and will cover the following topics:
The medical device act that has been enforced since May 1st this year, the implementation of the Unique Device Identifier system for Class III implantable medical devices in June 2021; the introduction of a new registration pathway for low-risk devices; the change in the registration fee that has been implemented since May 2021, and lastly, the update on abridged registration pathway for class II medical devices. Let’s review each update in detail.

The Medical Devices Act was issued in 2020 but has just been enforced in May 2021, and here are some of the highlights: The definition of medical device manufacturer has been broadened to include entities that conduct activities, such as packaging, labeling, sterilization, final inspection and release, or design and marketing. Therefore, moving forward, a QSD approval might also be required for those sites, including the original equipment manufacturer or OEM; The medical device dealers for certain high-risk products are now required not only to include a repair and maintenance service, but also to have a Good Distribution Practice certification; To establish a proper traceability record, the UDI for moderate to high-risk products must be submitted to the authority before being placed in the market. To provide better access to a market, a new registration pathway called “product listing” will be implemented for certain low-risk devices. As part of the efforts to increase the post marketing surveillance in Taiwan, certain high-risk medical device dealers will be required to submit a periodic safety monitoring report.

Prior to placing products on the market, the medical device license holder will be required to upload the corresponding product information to the UDI information management platform, which is the UDI database that is established by the Taiwan FDA. This process will require identification information such as license number and model number. It will also require device information such as catalogue number, product description and batch number, as well as other technical characteristics.
However, The implementation of this process will be done in phases. Starting with Class III implantable devices in June 2021, followed by Class III non-implantable devices in June 2022, and then Class II devices in June 2023. The Taiwan UDI must be created according to the standards formulated by the International Medical Device Regulators Forum (IMDFR).

If you are looking to register your products in Taiwan, consider LICENSALE, our Global MedTech Registration system for fast and easy market access.

Under the new medical device act, some of the class I medical devices are subject to product listing. There are 68 certain low-risk products that are eligible for this pathway. The application submission for this pathway will be done online like any other program or pathway. Under this pathway, the license holder is also required to submit an annual retention to the central competent authority. For those who fail to file such a declaration, the original listing shall become invalid. However, the details about the criteria and procedure for this pathway have not been provided by the Taiwan FDA.
In April 2021, the Taiwan FDA updated the registration fee for some services that they provided. As you can see in the table, the new fees are 1.5 to two times higher than the old fees, except for the renewal fee for class II and III. Fees for new services are also introduced, such as fee for class one product listing and the fee to issue a license or registration certificate.
Previously, the abridged registration pathway allowed Class II devices with both EU and US market clearance, an exemption from submission of the pre-clinical data. However, under the updated pathway, products must meet one of the following requirements to be eligible for the abridged registration pathway: First, the product must conform to the standards that have been pre-determined by the authority. Currently, only 8 low-risk devices belong to this category. While for the second requirement, 34 low or moderate-risk devices on this list will be eligible for an abridged registration pathway, regardless of its overseas approval status. Unfortunately, the change in this pathway will close the door for many imported Class II devices that are currently eligible under the previous abridged pathway requirement.

That's it for our update today! If you have any comments or questions, please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.