In a recent interview with Cindy Pelou, Head of the APACMed Secretariat’s Specialized Committee on Regulatory Affairs, Mr. Pak Fikriansyah from the Indonesian Ministry of Health (MOH) described recent initiatives by the MOH in the regulation of medical devices in Indonesia and offered some suggestions for the Indonesian medical device ecosystem.
A: During the relabeling process, the old address can be replaced as long as the company performing the relabeling has a standard certificate and can demonstrate that the relabeling (usually self-adhesive labels) does not affect the safety, quality and performance of the medical device.
Q: Which department of the Indonesian Ministry of Health currently reviews cell and gene therapy registrations?
A: Cell and gene therapy products are reviewed by the Indonesian Food and Drug Administration (BPOM) and the Directorate General of Drugs and Medical Materials.
Q: For companies that need to register their products, what is the applicable risk classification for medical devices? What is the expected timeline for registration approval?
A: The review of this information is the responsibility of FDA Indonesia (BPOM).
Q: Can minor labeling changes (e.g. symbol change/color change) be implemented with notification?
A: Currently, a change is allowed if it applies to all or most products. However, if it applies to only one or two products, a change notification is required.
Q: Between May and August 2021, we had discussions with the Ministry of Health (MOH) regarding a letter from Gakeslab containing proposals for RUO (research use only) registration in Indonesia. One of the recommendations was to exempt or simplify RUO registration (pre-market and post-market) in Indonesia. Exempting and simplifying RUO registration will help promote the research environment and support Indonesia in transforming its health pillar. As we continue to support the research environment in Indonesia, can we follow up with the Ministry of Health on RUO?
A: Indonesia’s Ministry of Health has discussed the RUO and gained insights from the way it is managed by the Health Sciences Authority (HSA) in Singapore. We learned that HSA does not regulate RUOs but implements strong post-marketing controls. There are severe sanctions if RUO products are used for treatment. However, given the large Indonesian market with a large number of laboratories, we will not be able to adopt this model. Indonesia is currently working to tighten regulation and we are open to discussions with APACMed and other stakeholders to provide best practices.
Q: Does Indonesia allow labeling after importation? (e.g. after a government tender for customs clearance or labeling change)
A: Relabeling is allowed after certification and assurance that there is no impact on the quality and safety of the product.
Q: What are the risks of importing goods with mixed labels? For example, the box label has the new company name but internally, the IFU (instructions for use of medical devices) still contains the old company name. Does the Indonesian Ministry of Health allow for a transition period so that the change in labeling/IFU is not considered a forced cessation requirement?
A: If there is a discrepancy between the IFU and the labeling, it will most likely be rejected as it is critical to maintain consistency. Although some case-by-case grace periods are provided, appeals and consideration of the impact on the community are still required. It is therefore highly recommended to ensure that all old labeled products have been imported before submitting an update to prevent re-importation and ensure a smooth transition. Depending on the scenario, you may also be able to relabel the product using the correct authorization.
Q: APACMed is promoting a regulatory trust program, what is the Indonesian Ministry of Health’s view on this program? As the current policy is to produce more local products, Indonesia could benefit from the trust model and allow for product expansion into other key ASEAN markets.
A: The Indonesian Ministry of Health is very interested in regulating the trust model and would like to collaborate with the Health Sciences Authority (HSA) of Singapore and the Medical Supplies Authority (TGA) of Australia. The initiative is still in its infancy, although implementation is expected next year. In conclusion, Indonesia is excited to learn and participate in the trust model and looks forward to working with APACMed on this project.
Q: Regarding Halal regulations (Halal Law), products made from non-halal materials need to display appropriate information on the label before they can be imported and distributed to Indonesia. Are there guidelines to determine whether our products are halal or non-halal?
A: Discussions on issuing labeling guidelines by 2024 are ongoing. We are still working on developing clear guidelines, trying not to complicate the original process. The Indonesian Ministry of Health welcomes suggestions on the best way to develop the guidelines.
Q: What is the government’s plan when a locally produced product/product reaches the required percentage of local content? (It was mentioned above that this product will be frozen in the e-catalog, what is the next step?)
A: Only products with different specifications from those produced locally will be allowed to enter the private market. This policy will continue until next year and may change after the 2024 elections. We will continue to monitor the prospects of the medical device sector.
Q: I would like to know if private hospitals will implement the Program to Encourage Increased Use of Local Products (P3DN)? If so, what is the expected timeline? Does this mean that private hospitals will only be able to purchase local products?
A: There is no specific program for the private market and hospitals at this time. Therefore, you are free to participate in private market trading and purchasing. Utilizing private markets for trading and purchasing.
Q: How does Indonesia handle refurbished medical equipment?
A: We incorporate the regulation of the Ministry of Trade and the Ministry of Industry that prohibits refurbished goods from entering the Indonesian market. This regulation was implemented in response to the challenges Indonesia faced in the past when only refurbished goods entered the market. The purpose of these regulations is to prevent the influx of refurbished goods in large quantities. We will prioritize product availability and always ensure consistent quality.
Q: Currently the Indonesian Ministry of Health’s classification grouping is based on device specifications, such as different shapes (left catheter, right catheter), which would require the registration of multiple licenses. Does the Ministry of Health have any plans to adjust the grouping based on the ASEAN Medical Device Directive (AMDD)?
A: You can view the guidance document on grouping on Indonesia’s website. Medical devices can be categorized into various classifications such as family, system and group. There is no additional charge for registration by group or individual product.
Q: Is there an intention to apply the same grouping for in vitro diagnostic products (IVD)?
A: IVD products are categorized into closed and open systems. There are more details available in the guidance document available on the Indonesian Ministry of Health website.The categorization of IVD products follows a similar pattern to that of AMDD. Discussions are still ongoing on how to align the grouping with the e-catalog system.
Q: Do non-halal products refer to products that contain materials of animal origin but are not halal certified, or do they refer to products that do not contain any materials of animal origin?
A: Products of non-animal origin do not require Halal certification. Only products containing animal origin are required. If the product does not comply with the Halal certification system, proper labeling is required.
Q: Will there be separate guidelines for IVD products in terms of halal regulations?
A: The current guidelines only apply to medical device products derived from animals. However, considering that IVDs come into direct contact with the patient’s body, it is possible that separate guidelines will be developed for them. However, there has been no discussion on IVD guidelines at this time.
Q: What happens if a Class D food product is older than the time it takes to obtain halal certification but comes from an animal?
A: This is a situation where additional labeling requirements would need to be met. We are currently in discussions to determine the specific type of labeling required. Our goal is to ensure that the regulations are appropriate and balanced to ensure patient safety and to avoid under- or over-regulation. It is important to note that this is not a ban on products entering the Indonesian market, only that labeling is required to enter the market.
Q: When a design change or product change occurs after product approval, the current practice is to resubmit the application. Is it possible to modify the procedure or other measures to avoid resubmission?
A: If the change involves labeling and packaging, a change modification procedure is possible. A change modification procedure is permitted if it can be ensured that the change will not affect the safety, quality, or effectiveness of the product.
Post time: Jul-28-2023