Several Regulatory Affairs Specialists from Qualtech’s offices in the ASEAN countries jointly accepted an invitation issued by OMETA (Overseas Medical Equipment Technical Assistants) to provide detailed updates on the medical device regulations in Thailand, the Philippines, and Vietnam. OMETA, a non-profit organization consisting of over 160 Japanese medical device manufacturers as members and supporting members, has been a long-term cooperating partner for Qualtech. Qualtech’s experts hence delivered a comprehensive presentation, during which the following new regulatory changes have been thoroughly introduced:
1. Updates for the Thailand Market:
Thailand’s FDA has implemented new medical device regulations based on the ASEAN Harmonization on February 15, 2021. Essentially, the Thai FDA is thereby transitioning from the old policy-based approach to the new risk classification-based system. Henceforth, all medical devices, as well as IVDs, are being categorized into 4 different risk classes:
- Class 1 (Low risk): Listings
- Class 2 and 3 (medium risk): Notified Medical Devices
- Class 4 (high risk): Licensed Medical Devices
An important update is further that medical device registration with the Thai FDA is now being processed via an online platform, incorporating the so-called “pre-submission” and “e-submission”. Pre-submission thereby represents the phase during which the Thai FDA will evaluate the product’s grouping and risk classification. It is thus noteworthy that the grouping of medical devices is now applicable under the new Thai regulations. Subsequently, e-submission follows as a second step, in which the Thai FDA will assess the product’s technical documents according to the CSDT dossier.
Thailand’s New Registration Processes:
The new process for Class 2, 3, and 4 products thus consist of the initial pre-submission (turnaround time is 15 working days), which is then followed by the e-submission, in order to obtain the final electronic approval certificate. The maximum reviewing time as per Thai FDA’s official statement for e-submission is as follows: Class 2 and Class 3 products 250 working days, and 300 working days for Class 4 products.
As for Class 1 (Listing MDs), the Thai FDA distinguished between medical devices that are sterile and/or measuring and those Class 1 products that are non-measuring and non-sterile. Similar to their Class 2, Class 3, and Class 4 counterparts, sterile/measuring Class 1 products are required to complete pre-submission as well as e-submission (maximum reviewing time by Thai FDA is 200 working days). While non-sterile/non-measuring Class 1 products can follow the Auto-Approval route under Thai FDA’s rules 10(1) & 12. Hence allowing for a much shorter turnaround time as they do not need to undergo e-submission after successful pre-submission.
Validity for the newly obtained product registration licenses will be 5 years after the license issuance for all risk classes. It is also crucial to note that the Thai FDA no longer accepts Free Sale Certificates for all risk classes. With regards to CSDT, the Thai FDA provides three different routes, consisting of “Full CSDT”, “Partial 1”, and “Partial 2”, depending on the specific conditions at hand.
2. Updates for the Philippines Market:
Along with the gradual implementation of PFDA’s Administrative Order 2018-002 for medical devices, PFDA has implemented the new FDA-Circular-No. 2021-002 earlier in March 2021. The new circular will primarily affect Certificates of Medical Device Notifications (CMDN) applications for Class B to D non-registrable products in the Philippines. Following the recent implementation of FC 2021-002, PFDA now processes applications for CMDNs for all non-registrable Class B, C, and D medical devices that are not included in the list of medical devices in Annex A of FDA Circular No 2020-001 and its subsequent amendments.
It is further eminently important to highlight that the validity of CMDNs is 2 years. Three months prior to the expiration of the CMDN, manufacturers shall apply for a Certificate of Medical Device Registration (CMDR) for their respective product(s).
- Entities with non-registerable medical devices of Class B, C, D are allowed to continue manufacturing, importing, exporting, distributing, and selling their MDs without a CMDN until March 31, 2022. Only a License to Operate (LTO) is required.
- Starting from April 1, 2022, until March 31, 2023, only approved CMDN or pending CMDN applications are allowed to conduct business in the Philippines.
- Starting from April 1, 2023, if the product has not yet obtained a CMDN, a CMDR is needed in order to continue business in the Philippines.
3. Updates for the Vietnam Market:
Vietnam’s MoH is currently in the transition phase from the old regulations Circular 30/2015 to the new regulations of Decree 36/2016 & 169/2018 for medical devices. At this point, Class A medical devices must already comply with the provisions of the new Decree No 36/2016. Class B, C, and D devices listed in the Annex of Circular No 30/2015/TT-BYT on the other hand, are required to apply for an import license and must further comply with the provisions of the old Circular No. 30/2015. However, products of class B, C, or D not listed in the abovementioned Annex, cannot apply for an import license. Instead, products under this condition must currently submit the “result of classification” during the importation process.
Important to note for holders of existing import permits originally valid until December 31st, 2018, 2019 or 2020, the import permits will automatically be extended until December 31st, 2021. This is yet only under the condition, that the LOA, CFS, and ISO are still valid.
With respect to the officially stated process times under the new regulations, Class A products will be processed by the Vietnamese authorities within 7 working days (the validity of class A approvals is permanent). As for Class B, C, and D products, Vietnam’s MoH’s reviewing time is stated to be 60 days (validity under the new regulations will be 5 years after issuance of the registration number).
Another essential aspect that is to be kept in mind is that ASEAN’s CSDT is being implemented in Vietnam from January 1, 2022.
MoH’s Selected Cases for Priority Review:
Under the new regulations Decree 36/2016 & 169/2018, Vietnam’s MoH is reviewing the applications with the following priority cases first:
A) Domestic products having been produced in Vietnam,
B) Products that only have a single purpose, which is the sterilization of other medical devices.
C) Products that fulfill one of the below conditions, which renders them eligible for Vietnam’s MoH’s fast application:
● Medical devices that have obtained 2 out of 5 GHTF countries’ CFS (USA, EU, Canada, Japan, or Australia), plus England or Switzerland. Alternatively, at least 1 CFS and 1 approval from the GHTF reference countries (plus England or Switzerland).
● Medical devices eligible for Vietnam’s fast application also include products that have been circulated in Vietnam before December 31, 2018. These products must additionally meet the requirements of having circulated for at least 3 years within 5 years of the date of filing, and there shall be no warning information regarding the quality and safety of the device.
● Vietnam’s new draft decree will also bring additional routes for allowing products to undergo fast application. This includes the case of products already having a Vietnam import permit while having been circulated in at least two other countries, in which at least one of the CFS is issued from the list of Vietnam’s MoH’s selected reference countries.
Shall you have any questions regarding the new regulatory updates in Thailand, the Philippines, or Vietnam, or in case you would like to register your products in one of the ASEAN markets, please feel free to contact us at your earliest convenience: firstname.lastname@example.org
OMETA: Overseas Medical Technical Assistants