1. Indonesia:
The Ministry of Health Regulation (Permenkes) No. 14 of 2021 mandates the integration of the medical device facility licensing system SERALKES (by December 2021) and the medical device licensing system REGALKES (by February 2022) with the Online Single Submission Risk-Based Approach (OSS RBA) [1]. Manufacturers and distributors are now required to have GMP and GDP certification, and by 2023, distributors must also be GDP certified.
On a separate note, the Indonesian SatuSehat platform is being developed to integrate all healthcare systems and big data for integrated health services. In this regard, also a Pharmaceutical and Medical Device Dictionary (KFA)[2] has been developed. It represents a standardized data dictionary for pharmaceuticals and medical devices to be used in the SatuSehat platform and the e-katalog system.
 

Moreover, medical devices circulating in Indonesia are required to be certified halal [3] according to government regulation No. 39/2021, except for those originating from prohibited materials (haram). Halal certification is mandatory for medical devices containing animal elements or originating from them. The enforcement of the regulation will be conducted gradually, with each risk classification having its own timeline. Lastly, Presidential Decree No. 6/2023 has been issued, which specifically discusses halal certification for medical devices and which will serve as the basis for future halal regulations.

2. Singapore:
The Health Sciences Authority (HSA) in Singapore published several minor regulatory updates this as well as last year. Firstly, from January 2022, only COVID-19 tests that were registered with HSA or authorized under the Pandemic Special Access Route (PSAR) [1] were allowed to be supplied in Singapore. HSA categorized any unregistered test kits as "emergency medical devices," which HSA evaluated to determine their safety, quality, and efficacy. HSA also published regulatory guidelines for Laboratory Developed Tests (LDTs) [2]. Clinical laboratories are now responsible for ensuring the safety and efficacy of their LDTs and are required to notify HSA of their use through the Healthcare Application and Licensing Portal (HALP) and report adverse events, Field Safety Corrective Actions (FSCAs), and recalls associated with LDT use.

Lastly, the Singapore government proposed a Cybersecurity Labeling Scheme (CLS) [3][4] for medical devices to enhance their cybersecurity protection. This collaborative action by the Cyber Security Agency of Singapore (CSA), Ministry of Health (MOH), Health Sciences Authority (HSA), and Integrated Health Information Systems (IHiS) was based on the international standard for medical device cybersecurity. The CLS requires relevant medical device manufacturers to conduct a cybersecurity risk assessment and implement appropriate security controls. A label indicating the cybersecurity level of a device is expected to help end-users make informed decisions. HSA held a public consultation in March 2023 to seek feedback before implementing the scheme, which is expected to become mandatory in the near future.

3. The Philippines:
The Philippine Food and Drug Administration (PFDA) have extended the deadline for Class B, C, and D medical devices not included in the list of registrable medical devices to be sold without a Certificate of Medical Device Notification (CMDN) until March 2024 [1]. Applications for CMDN for these devices will be accepted until that date, and companies may choose to apply for a Certificate of Medical Device Registration (CMDR) instead. After 1^st April 2024, the manufacture, importation, exportation, distribution, transfer, sale, or offering for sale of all Class B, C, and D medical devices without a CMDN/CMDR or with a pending application will be prohibited. Marketing authorization holders (MAH) with an expiring CMDN must apply for a CMDR at least six months prior to its expiration.

Also, the PFDA released a circular, FDA Circular No. 2022-008, that provides guidelines for the abridged processing [2] of registration applications for Class B, C, and D medical devices covered under Administrative Order No. 2018-0002 with product approval from any ASEAN member country's NRA under AMDD-CSDT. Applications that meet the requirements must attest that the CSDT technical documentation they have submitted is the most recent version that the reference NRA has filed or approved. Legal requirements will be fully evaluated, while labeling requirements will be the focus of technical evaluation. The abridged process has a shorter expected turnaround time than a regular application process. In vitro diagnostics and refurbished medical devices are not covered by this circular.

4. Malaysia:
Malaysia MDA has implemented several revisions and updates to existing guidances, including amendments to the MDA change notification process for registered medical devices (MDA/GD/0020) [1]. Most notably, the turnaround time has been updated as follows:
- As for Category 2 OR Category 3 Single Submission Change Notifications, MDA will now return to the applicant within 30 working days with their first feedback.
- Regarding Category 2 AND Category 3 Single Submission Change Notifications filed in one application together, MDA will take around 60 working days to review and to give their first feedback to the respective applicant.
Overall, as based on Qualtech’s experience, the change notification process may take a total of  3 months to be completed.

In addition. the guidance regarding the requirements for labelling of medical device (MDA/GD/0026) has also been updated [2]. The updated guidance now informs that the name, address, and contact details (email and/or phone number and/or website) of the manufacturer and the authorized representative are required to be present on the label. Furthermore, included shall also be the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the included purpose of the device.

Lastly, there have been also been new guidances with MDA. One of the most noteworthy new guidance is about the Harmonized Classification of Medical Devices in ASEAN (MDA/GD/0062) [3]. This guidance document provides the harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/purpose as claimed by the manufacturer. Thus, representing a wonderful tool for every manufacturer to check, in case they are uncertain about their product’s risk classification.

5. Vietnam:
Pertaining to Vietnam, the Vietnam’s MoH had issued the decree 7/2023/ND-CP in March in 2023, with the purpose of amending the previous decree 98/2021 [1] and [2].

Along with this came the following important changes on the subject of the transition terms for the Vietnam Import Permit. Firstly, it is important to note that applications for an Import Permit have been closed since January 1st, 2022. However, the already approved Import Permits will be valid until December 31st, 2024. Likewise, Medical Devices with a classification letter, which were previously not required to obtain an Import Permit, can still be imported until December 31st, 2024.

As for currently pending Import Permit Applications with Vietnam’s MoH, dossiers of import permits that were submitted before January 1, 2022, but that have not been approved yet: Vietnam MoH has proposed the following two options:

-  Option 1: The applicant shall apply for a registration number (permanently valid). The respective registrant may also send a letter to MOH to be prioritized.

• -  Option 2: The applicant may continue the application for the import permit. In that case, Vietnam’s MoH will continue to review the Import Permit Application and issue the permit accordingly, which will then be effective until December 31, 2024.

As with regards to the product registration in Vietnam, CSDT will be required for class C and class D starting from January 1st, 2024. That is,
- Starting from January 1st, 2024, CSDT will be mandatory.

- Before December 31st, 2023: Only a brief description, IFU, Labelling, etc. will have to be submitted.

Further, please note that the maximum number of compliances for fast-track registration applications and full evaluation registration (submitted before 2024) and import license application to Vietnam’s MoH has been adjusted from five to only three compliances.

6. Thailand:
As for the important updates for Thai FDA, it is noteworthy to point out that Thailand registration can be processed either via the full evaluation route or via three different expedited registration routes. However, five medical device categories are required to be processed via the full evaluation route, as outlined below:
- 1. Medical devices with new technology (AI: Artificial Intelligence).
- 2. Medical devices, which are amended from hospitals and professional use to home use. For example, laser hair stimulation, or LED red light wrinkle reduction or other light colors (except blue light to treat acne).
- 3. Medical devices that require a “specialist evaluation” to prove their efficacy and safety. This includes for instance, products that do not contain HA but that are used to correct skin defects, silk products used for lifting products used for intracellular storage, such as PRP or stem cells and injecting such cells back into the human body.
- 4. Medical devices with serious adverse events history or device deficiencies, which may lead to serious adverse device effect.
- 5. Medical devices with specific guidance announced by the Ministry of Public Health:
Injectable Hyaluronic Acid for Skin Correction

- Implanted Silicone Breast Prosthesis

• - Human Blood Bag

• - Condom

• - Ophthalmic Viscosurgical Devices

• - Surgical Gloves

• - Contact Lens

• - Concentrate for Haemodialysis

• - Teeth Whitening

• - Contact Lens Care Products

• - Products Containing Alcohol for Medical Device

• - Physical Therapy Devices

• - Insulin Syringe (U-40, U0100)

• - HIV Test Kits

• - HIV Screening (Self-test)

• - Methamphetamine Urine Drug Test Kits
  

For other products not covered in the 5 categories above requiring Thai FDA full evaluation, they may be eligible for either of the 3 expedited registration routes currently in existence in Thailand as outlined below:



* Registration costs for the expedited routes will be reduced by 53,000 baht (depends on its risk classification), a waiver cost on the expert review process

 

References:

Indonesia:
[1] Integration of MoH Licensing System with OSS RBA (Online Single Submission Risk-Based Approach)

[2] Pharmaceutical and Medical Device Dictionary

[3] Presidential Decree No 6/2023 on Halal Certification for Drugs, Biological Products, and Medical Devices

Singapore:
[1] Singapore HSA Published List of Covid-19 Test Kits Authorized for Professional Use

[2] HSA Publishes Regulatory Guidelines for Laboratory Developed Tests (LDTS)

[3] Announcement on Public Consultation for the Proposed Framework and Implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)]

[4] Cybersecurity Labelling Scheme for Medical Devices
 
The Philippines:
[1] Abridged Process for Registration of ASEAN Approved Medical Devices

[2] PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices

Malaysia:
[1] Change Notification for Registered Medical Device

[2] Requirements for Labelling of Medical Device

[3] Harmonized Classification of Medical Devices in ASEAN

Vietnam:
[1] Decree 07/2023/ND-CP Dated March 3 of 2023 Amends and Supplements Decree 98/2021/ND-CP  
[2] Decree 07/2023/ND-CP dated March 3, 2023 amending and supplementing the Government's Decree No. 98/2021/ND-CP dated November 8, 2021 on medical device management.

Thailand:
[1] WHO Collaborative Registration Procedure for IVD Products in Thailand