2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies. When these come into full implementation in 2022, stakeholders need to be well-equipped to face them and prepare a contingency plan to adopt them for the medical devices already in the market. In this article, we shall take a look at the regulations to be fully implemented starting 2022 in Malaysia, Singapore, Indonesia, and the Philippines.
1. Medical Devices (Establishment Duties and Obligations) Regulations 2019
Starting from July 1, 2022, MDA will effectively enforce the Medical Devices (Establishment Duties and Obligations) Regulations 2019. The regulation focuses on local medical device establishments’ responsibilities in conducting post-market activities.
All medical device establishments need to pay extra attention to the following post-market activities, according to their respective responsibilities. Please refer to the corresponding guidance documents for details on how to maintain these activities in the supply chain:
i. Distribution records
ii. Complaint handling record
iii. Mandatory problem reporting
iv. Field Corrective Action (FCA)
v. Medical Device Recall
Head over to our past Qualtech Newsletter article here to read up more on this regulation.
2. Medical Devices (Advertising) Regulations 2019
All forms of advertisement used for registered medical devices in Malaysia must now comply with the conditions set out in Section 44 of the Medical Devices Act (Act 737) and the Medical Devices (Advertising)
Regulations 2019. To advertise registered medical devices to the non-professional and general public community, manufacturers are required to receive written approval from MDA, upon submitting a paid application. Distributing unregistered advertisement materials is an offense. To further understand the regulations, MDA has also published the following guidance documents:
i. MDA/GD/0032: Code of Advertisement (COA), which explains the advertising code that must be followed when advertising a registered medical device.
ii. MDA/GL/04: Guideline Application for Medical Device Advertisement Approval - Requirements, which explains how to apply for approval of medical device advertisements. — Full enforcement of these Regulations will commence on 1 January 2022.
You can also read up on the main regulation from our past Qualtech Newsletter articles here.
Singapore’s Health Sciences Authority (HSA) is the first southeast Asian regulatory agency to introduce and fully implement the Unique Device Identification (UDI) system, to improve medical device safety and traceability in the country.
The HSA has set up a phased implementation schedule for UDI compliance based on device type and risk classification:
Singapore market registrants selling Class B, C, and D devices may begin submitting UDI Device Identifier (UDI-DI) data into HSA's Medical Device Information and Communication System (MEDICS) online submission system on August 31, 2021. Please follow this link to read up further on this pioneer and crucial regulation, which may soon be followed suit by other ASEAN countries.
1. Devices that are no longer defined as medical devices in Indonesia do not require a marketing authorization license, prior to circulating the products in Indonesia.
- Vaccine and pharmaceutical (medical) storage /refrigerator
- Oxygen Cylinders that do not have thermally insulated containers
2. Regulation regarding additional Validation Test for Rapid Test Antigen (RDT-Ag) (click here for past Qualtech Newsletter article)
A validation test in the appointed local laboratory will be required before submitting for registration or renewal of RDT-Ag products in Indonesia. After receiving an approval certificate from the Indonesia Ministry of Health or in the post-market stage, RDT-Ag products are also required to carry out TWO more validation tests at the appointed local testing laboratory.
3. Halal Certification in Indonesia
The Ministry of Religion is gradually developing a halal policy for products circulating in Indonesia, one of which is medical devices containing animal derivatives. This policy itself started on 17 October 2021, but the due date of full enforcement for medical devices varies according to the risk classification as follows:
In addition to this, the Ministry of Religion has also described 17 categories of medical devices that must be certified halal, as stipulated in “Decree of the Minister of Religion Number 748 of 2021” concerning Types of Mandatory Products Halal Certified.
4. Updates on the regulation concerning registration of medical devices in Indonesia.
There is now a simplified route for certain class A medical devices’ registration in Indonesia. To improve the ease of licensing process, the Ministry of Health has simplified the registration route for certain class A medical devices that have the following criteria:
ii. Non-Sterile, and
For a detailed list of selected Class A Medical Devices which can qualify for this simplified registration route, please refer to this article. Currently, MOH is still in the improvement stage and has yet to announce the date of implementation.
5. Post Market Activities Guidance for medical device in Indonesia
In March 2021, the Ministry of Health had issued guidelines for handling post-market activities of medical devices in Indonesia and also launch the online reporting system called e-watch.
Following are the related articles and guidances:
A. Procedures for Withdrawal and Destruction of Non-Conforming Medical Device
This guidebook describes the type of withdrawal of MD (voluntary or mandatory), the Criteria of MD that are required to be withdrawn, the duration of product withdrawal according to its risk, and the flowchart of product withdrawal. For the detail, please refer to below:
- Article of Procedures for Withdrawal and Destruction of Non-Conforming Medical Device
- Guidebook of Procedures for Withdrawal and Destruction of Non-Conforming Medical Device
B. Medical Device Adverse Event Reporting and Procedure
This guidebook is explaining about the criteria of adverse events which need to be reported and the period of reporting it. For the detail, please refer to below:
- Article of Medical Device Adverse Event Reporting and Procedure
- Guidebook of Medical Device Adverse Event Reporting and Procedure
The Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4 in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be exempted from the Specialist Review requirement in Thailand. By avoiding the Specialist Review, the Program intends to reduce the review time to 60 days while also saving manufacturers the $1,700 (53,000 Baht) Review fee. The program is meant to leverage device conformity assessments performed by the Singapore HSA for expedited registration in Thailand. Manufacturers can now make use of this golden opportunity to shorten the market entry timeline for their class 4 medical devices in Thailand. Please click here to read further on the procedures.
Vietnam’s medical device regulatory landscape has some interesting updates, as well. Some of these are already in implementation while others are waiting to be enforced in the coming years.
- Risk classification of medical devices will be determined by the license holder.
- Class A and B will apply for a Declaration of Applicable Standard, while classes C and D submit applications for a Certificate of MD Registration.
- Registration Number (Declaration of Applicable Standard or Certificate of MD registration) is permanently valid.
- Class A/B application is reviewed by the Department of Health in approximately 10 business days while Class C/D application is reviewed by the Minister of Health in approximately 40 days.
- Quick issue for class C/D application is reviewed in approximately 10 business days. Two cases that can apply for quick issue are:
- MD that has been granted 1 CFS from reference countries including US, Canada, Japan, Australia, EU countries, England, Switzerland, China, and Korea.
- MD that has been granted an Import Permit (IP).
- No CSDT format is required to be submitted until January 1st of 2023.
Please read further on Decree98/2021/NĐ-CP Medical Device Management, which describes the above-mentioned points, here.
Medical device regulations are set to change greatly in 2022 for PFDA.
- After the first quarter of the year, there will no longer be direct importation or exemption to registration/notification of medical devices prior to marketing in the country.
- Importers and distributors are now required to disclose their financial relationship with medical establishments and medical practitioners twice a year.
- Interested parties and affected entities must also watch out for the effectiveness and start of the transition period to the regulation of medical device retailers.
- Changes to the COVID-19 related regulations are also expected depending on the supplies and products needed to combat the pandemic.
If you are keen to introduce your medical device in the booming ASEAN market, Qualtech is your best partner to make a smooth and effortless entry. Quickly get in touch with us to discuss how we can market your medical device in multiple ASEAN counties simultaneously.