President's Newsletter: February/March 2020

Alexander C. Feldman
Alexander C. Feldman
President & CEO
US-ASEAN Business Council

President's Newsletter

February/March 2020

Dear Members,

COVID-19 (Coronavirus) is clearly having a huge impact on Southeast Asia, the world and each of your businesses. We learned late on Friday evening that the U.S. Government has decided to postpone its upcoming ASEAN-U.S. Special Leaders' Summit, which was expected to take place on March 14, 2020 outside of Las Vegas, NV. As such, the US-ASEAN Technology Summit, which the Council was helping to organize with Google and was scheduled to take place on the sidelines of the Leaders' Summit, has also been postponed.

We hope that the US-ASEAN Technology Summit, despite the current postponement, will eventually serve as a unique opportunity for senior leaders from ASEAN and the U.S. government, CEOs and leaders from the most innovative technology companies across the United States, and industry thought leaders to discuss cross-cutting technology issues that are of greatest importance for American companies and the future of Southeast Asia in line with the Free and Open Indo Pacific vision. We look forward to working with Google and coordinating with our government counterparts to host the Technology Summit at a later date and hope to see the administration’s continued commitment to ASEAN, which remains critically important for the U.S. economy. In light of this decision, the US-ASEAN Digital Economy Roadshow is also now postponed. We are grateful for our members’ support for this important engagement, including Facebook, Google, Qualcomm, Oracle and Cisco. We hope to reschedule this as soon as the global situation and Ministers’ schedules allow.

We are closely monitoring the political situation in Malaysia as The Pakatan Harapan (PH) ruling coalition government collapsed on February 24 with the announcements of Parti Pribumi Bersatu Malaysia (Bersatu), the former PH component member with 26 federal lawmakers, pulling out of the coalition and the resignation of 11 People’s Justice Party (PKR) members of Parliament, including former PKR deputy president Datuk Seri Mohamed Azmin Ali. This led to the resignation of Prime Minister Tun Dr. Mahathir Mohamad, who also resigned as Chairman of Bersatu. The King had officially accepted Prime Minister Mahathir’s resignation but decided to appoint him as the interim Prime Minister. The appointments of the deputy prime minister, ministers, deputy ministers and political secretaries have all been revoked. The interim Prime Minister ran the country until, on February 29, Malaysia’s King determined that Tan Sri Muhyiddin Yasin had the necessary 112 votes in Parliament to become the next Prime Minister and he was duly sworn in the next day, March 1, as the 8th Prime Minister of Malaysia. Parliament will meet next on May 18 and former Prime Minister Mahathir claims that he actually has the necessary votes in Parliament to become the 9th Prime Minister of Malaysia. We anticipate another rocky few months in Malaysia in the lead up to May 18.

We are also tracking closely U.S.-Philippines bilateral relations. On February 11, the Philippines sent the official notice of termination ending the U.S.-Philippines Visiting Forces Agreement (VFA). The VFA termination takes legal effect in 180 days unless parties agree otherwise. The VFA reaffirms obligations under the 1951 Mutual Defense Treaty and sets rules on U.S. personnel visiting the Philippines including rules on entry, temporary stay and departure as well as the exercise of criminal jurisdiction. The termination notice came after President Duterte’s order banning members of the Cabinet from traveling to the United States. The U.S. travel ban was first reported on January 29. Philippine and international press point out that President Duterte ordered the U.S. travel ban after key ally Senator “Bato” dela Rosa, former national police chief over the administration’s drug war, confirmed that his U.S. visa was canceled. It has been reported that Duterte’s decision to terminate the VFA was not solely based on dela Rosa's canceled visa, but was also anchored on the U.S. Senate's adoption of a resolution that seeks Global Magnitsky Act sanctions against Philippine officials involved in extrajudicial killings and the detention of Senator Leila de Lima. On February 18, I joined by video the US-Philippines Society Board meeting and gave the perspective of American business to promote greater trade and investment in the Philippines.

Despite the Coronavirus challenges, the Council is leading a total of 28 member companies from March 3-5 on our annual business mission to Vietnam, as well as 19 member companies for our annual Health & Life Sciences Industry Mission to Vietnam, with five companies overlapping on both missions. U.S. Ambassador Dan Kritenbrink has expressed his informed confidence in the way that the Vietnam Government has handled the outbreak. The U.S. CDC has a full-time presence in Vietnam and has been working closely with the Vietnam government and recently removed Vietnam from their country watch list for Covid-19. This year, our mission, coming on the 25th anniversary year of full diplomatic relations between Vietnam and the United States, included a CSR Exhibition which featured a sampling of CSR programs that U.S. companies have conducted or sponsored in Vietnam. Contributing to local communities is one of the areas that set U.S. companies apart from the businesses from other nations. Each sponsoring company had a booth displaying information about their key CSR activities.

The mission also included a Gala Dinner to celebrate the 25th anniversary of U.S.-Vietnam relations and highlight the role the U.S. business community plays in the bilateral relationship and its contribution to Vietnam’s development. During the Vietnam Business Mission, the Council delegation engaged with key Government officials, most notably Prime Minister Nguyen Xuan Phuc on March 4. Immediately following this meeting, Prime Minister Phuc witnessed the signing of a Memorandum of Understanding between the Council and the Ministry of Industry and Trade (MOIT) on strengthening industrial trade and cooperation in order to create a favorable business environment that promotes regular exchanges between the U.S. private sector and MOIT. Over the course of three days, other officials that the delegation engaged included Chairman of the Central Party Committee on Economic Affairs Nguyen Van Binh, Chairman of the Office of the Government Mai Tien Dung, Minister of Planning & Investment Nguyen Chi Dung, Minister of Information and Communications Nguyen Manh Hung, Minister of Culture, Sports & Tourism Nguyen Ngoc Thien, and leaders of other key Ministries and State agencies.

On February 28, the Council hosted U.S. Ambassador to Malaysia Kamala Shirin Lakhdhir and U.S. Ambassador to Cambodia W. Patrick Murphy, in separate roundtable discussions in Washington, on the sidelines of the U.S. State Department’s Chiefs of Mission Conference. This was a great opportunity for members to raise their business issues directly with the Ambassadors and explore challenges and opportunities in the Malaysian and Cambodian markets.

On February 25, the Council, in cooperation with CropLife Asia and the EU-ASEAN Business Council, conducted a workshop in Jakarta with national, regional and international food value chain stakeholders that signaled the third installment of the ASEAN Safe, Nutritious Food PPP Initiative. The workshop included a series of best-practice panels where ‘successes and setbacks’ in the various components that make up the food value chain in Indonesia were discussed. Immediately following the workshop, the Council conducted its 2020 Food & Agriculture Industry Mission to Indonesia on February 26-27. During the mission, the Council delegation offered to support the Government of Indonesia's agriculture development objectives and promote the roles of international trade and foreign investment in improving food security and strengthening the role of the agricultural sector as an engine of growth in the broader economy.

On February 13, the Council, in cooperation with the Embassy of the Republic of Indonesia in Washington, DC, the Development Finance Corporation (DFC), the U.S. Chamber of Commerce and the Business Council for International Understanding, hosted a joint briefing and discussion on Indonesia's National Strategic Investment Projects in infrastructure, energy and digital connectivity, featuring H.E. Luhut Pandjaitan, Coordinating Minister for Maritime and Investment Affairs. During the briefing, Minister Luhut shared details of Indonesia’s priority investment project plans, including hydropower, nickel for battery production, autonomous vehicles and toll roads, focusing on locations outside of Java and the new capital city. Minister Luhut and DFC also shared more information on the Sovereign Wealth Fund totaling US$ 5 billion that aims to give more confidence to U.S investors, particularly in the infrastructure, ICT, and energy sectors.

Also on February 13, the Council, in partnership with the US-India Strategic Partnership Forum, hosted the first event in our 2020 Indo-Pacific Briefing series in the Russell Senate Office Building. “The Indo-Pacific Briefing: Political, Trade, and Security Trends” featured remarks by H.E. Thani Thongphakdi, Thailand’s Ambassador to the United States, and Embassy of India’s Deputy Chief of Mission Amit Kumar on varying constructs of what “Indo-Pacific” means to governments in the Asia Pacific region. The two diplomats also held a lengthy discussion moderated by Ernie Bower, CEO of BowerGroupAsia, on current political, security and trade developments in the region. With the briefing being held prior to President Trump’s recent visit to India, the forum was timely and well attended by members of the Washington business, policy, government and academic communities.

On March 26-27, the Council will organize its annual mission to the ASEAN Finance Ministers and Central Bank Governors Meeting (AFMGM) in Ha Long Bay, Quang Ninh, Vietnam. The AFMGM is the best opportunity for members to meet ASEAN's finance leaders all at once in an open setting, providing opportunities to learn and exchange perspectives on financial integration issues and the priorities of individual governments. The Government of Vietnam is the current chair of ASEAN and has identified sustainable finance as one of its top priorities for regional development of ASEAN's digital economy.




February/March Highlights

Witnessed by Prime Minister of Vietnam Nguyễn Xuân Phúc, Minister of Industry and Trade Trần Tuấn Anh and US-ABC Chairman, President, and CEO Alex Feldman exchanged a Memorandum of Understanding (MOU) on enhancing industry and trade co-operation between the Ministry of Industry and Trade and the US-ABC.

The “Investment Briefing on Indonesia's National Strategic Projects,” which focused on infrastructure, energy and digital connectivity, was held on February 13, 2020, with H.E. Luhut Pandjaitan, the Coordinating Minister for Maritime and Investment Affairs of Indonesia. Minister of Trade H.E. Agus Suparmanto, ICT Minister H.E. Johnny G Plate, and Vice Minister for Foreign Affairs H.E. Mahendra Siregar were also in attendance. The event was co-organized by the Embassy of the Republic of Indonesia in Washington DC, the U.S. International Development Finance Corporation, the US-ASEAN Business Council, the U.S. Chamber of Commerce, and the Business Council for International Understanding.

During Indonesia Trade Minister Agus Suparmanto’s official visit to Washington DC, Council Chairman, President & CEO Alex Feldman and the US-ABC Indonesia team were warmly welcomed by the minister and his team at the Embassy of the Republic of Indonesia. Both parties had a constructive discussion on strengthening public-private cooperation and supporting the Ministry of Trade’s goals to balance U.S.-Indonesia trade, double the bilateral trade value, reduce trade barriers and improve the investment climate in Indonesia.

From left to right: H.E. Thani Thongphakdi, Ambassador of the Royal Thai Embassy-Washington; Ernie Bower, CEO BowerGroupAsia; Marc Mealy, Senior Vice President-Policy, US-ASEAN Business Council.
On February 13, the Council, in partnership with the US-India Strategic Partnership Forum, hosted the first event in our 2020 Indo-Pacific Briefing series in the Russell Senate Office Building.


Country, Industry and Advocacy Updates


Key Developments

  • Indonesia Proposes to Impose New Excise Tax on Sugar-Sweetened Drinks
    In an attempt to address the public health challenges of diabetes and obesity in Indonesia and to generate additional government tax revenue, on February 19 the Indonesian Finance Minister Sri Mulyani Indrawati proposed an excise tax on sugar and artificial sugar-sweetened beverages (SSB). The proposal is to levy excise taxes ranging from 1,500 rupiah to 2,500 rupiah ($0.11-$0.18) per liter on beverages such as bottled tea, coffee, carbonated soft drinks and energy drinks. The MOF estimates the taxes could generate additional revenue 6.25 trillion rupiah (US$447.53 million) for the government. The excise tax on SSB is a part of a larger tax policy proposal which also includes duties on vehicles and plastic, which MOF expects will generate 23.56 trillion rupiah (US$1.72 billion) in additional tax revenue. In 2019, Indonesia had a nearly US$15 billion revenue shortfall. The Minister did not specify when the government plans to begin collecting these taxes. In response to the proposal, Chairman of the Indonesian Food and Beverage Association Adhi S Lukman said the proposal would increase prices and hurt people's purchasing power. He cited lack of evidence that excise will reduce the risk of non-communicable diseases and obesity and added that he would lobby against the measure. In 2018, around 2% of Indonesians age 15 and above suffer from diabetes, up from 1.1% in 2007, while the number of obese adults rose from 10.5% in 2007 to 21.8% in 2018. The Council and industry have consistently highlighted examples to AMS’ of how additional taxes on sugar sweetened beverages have not been effective in reducing levels of disease and producing expected levels of additional revenue. This issue will be included in discussion agendas in future meetings with Minister Sri Mulyani.
  • Coronavirus (Covid-19) in ASEAN Update
    As the COVID-19 virus outbreak prolongs and disrupts ASEAN economies, on February 20 the ASEAN Coordinating Council (ACC), ASEAN and Chinese Foreign Ministers met in the ACC’s Special ASEAN-China Foreign Ministers’ Meeting on Coronavirus Disease in Lao to discuss response to the outbreak. The ACC welcomed the timely and effective measures of member countries, healthcare co-operation and ASEAN agencies to share information and experience in preventing, diagnosing, treating and controlling the disease. Vietnam Deputy Prime Minister, Minister of Foreign Affairs Pham Binh Minh speaking at the meeting proposed pursuing a balanced approach in fighting the epidemic and maintaining open economic policies, while ensuring regular updates were made available to the public. He also stated that ASEAN activities in Vietnam in 2020 would go ahead as scheduled, and Vietnam would take measures to ensure safety for participants. The ACC will compile a report on the COVID-19 to be submitted to ASEAN leaders at the 36th ASEAN Summit, scheduled in Vietnam in April. The meeting follows South Korea confirming a 31st patient on February 17, who had travelled throughout Korea prior to being admitted. The number of infected cases soared to 1,261, followed by South Korea raising the highest alert level for Covid-19 on February 23. Brunei, Indonesia, Singapore, and Vietnam had issued travel advisory to and tightened monitoring incoming flights from South Korea. As of February 26, Singapore reported 91 cases (of which 62 has recovered), Thailand 40 cases (22 recovered), Malaysia 22 cases (18 recovered), Philippines 3 cases (1 recovered and 1 death), and Cambodia 1 case (1 recovered). Vietnam, previously reported 16 cases, confirmed that all infected patients have recovered on February 25. On February 27, the U.S. CDC has decided to take Vietnam off the list of countries with the risk of community spread of the virus. Prior to the ACC meeting, on February 12 Cambodian Prime Minister Hun Sen agreed to let a Holland cruise ship MS Westerdam to dock and disembark its 1,455 passengers and 802 crew, after previously refused by five countries. As the passengers returned to their home countries, the Malaysian Health Ministry on February 17 announced that one passenger out of 145 transiting through Malaysia was confirmed infected. On February 20, the passenger has tested negative for the virus. The Malaysia Government has announced that the government would forbid cruise ships that had left or transited through China to enter Malaysia.
  • Vietnam Responses to Covid-19 Impact on the Economy
    As the novel coronavirus, now officially named Covid-19, recorded over 2,000 deaths globally and over 1,000 cases outside of mainland China, Vietnam was lauded by the World Health Organization (WHO) on February 15 for its effort to contain and control the outbreak. On February 8, the Ministry of Finance (MoF) announced a decision to exempt import tariffs on hygienic supplies needed to prevent virus infection. As of February 19, Vietnam confirmed 16 cases and has quarantined Vinh Phuc province after confirming eight patients infected in the province. On the other hand, the Vietnamese Government is also assessing the virus disruption to the economy. The Ministry of Planning and Investment (MPI) stated that Vietnam would potentially lose US$1.82 billion in state budget revenue because of the virus disrupting trading activities, decreasing revenue from domestic taxes and crude oil. MPI also stated in case the Covid-19 epidemic is contained in the coming two or three months, industries such as tourism, transportation, commerce, agricultural export – import, among others, are predicted to be the most vulnerable. See more.
  • Vietnam Central Bank Drops Plan to Cap Foreign Ownership in E-Payment Companies
    As part of the national financial inclusion strategy 2020-2025 which aims to regulate non-cash transaction and increase the number of transactions by 20 to 25 percent annually, the State Bank of Vietnam (SBV) in November 2019 released a draft plan to cap foreign ownership of e-payment companies at 49 percent. After consulting with industry experts and participants via a workshop held by the Vietnam Chamber of Commerce and Industry (VCCI) in December 2019, SBV on February 11 announced that it will scrap the decision. See more.
  • Indonesia Bans Live Animal Imports from China Amid Coronavirus Outbreak
    In response to the spread of the coronavirus, Indonesian authorities this month placed a temporary ban on all live animal imports from China amid fears the outbreak could spread through imports. The ban entered into effect on February 7 and applies to all live animals that arrived in Indonesia ports from that date forward. Live animals arriving after the date will be re-exported to the country of origin or will be destroyed, and exporters could be subject to sanctions. While the live animal import ban has been viewed generally as a positive response to protect Indonesian citizens, industry stakeholders are concerned an expansion of the import ban to other products will negatively impact the economy. In 2019, live animal imports into Indonesia totaled just $314,295, compared to larger industries that could be affected by the virus, including garlic, chili and salt. The food and beverage industry is heavily dependent on imported Chinese products and would suffer significantly from additional import bans of Chinese goods. In February, Trade Minister Agus Suparmanto announced the ministry is considering more import bans that could potentially spread the coronavirus, but the government will be looking into other countries that could supply the affected products. Indonesia has also banned all travel to and from China and suspended visa provisions for Chinese nationals while the outbreak persists. China is Indonesia’s top trade partner and largest export market, and industry players also fear a decline in overall demand for Indonesian exports, including crude palm oil and minerals, the longer the ban remains.
  • Philippine House Representative Filed Bill Seeking More Comprehensive Control of Drug, Medical Equipment Prices
    Oh February 6, Albay Rep. Jose Maria Clemente S. Salceda, who also heads the House Ways and Means committee, filed House Bill 6219 or the “Affordable Medicines, Medical Equipment and Supplies Act” (AMMESA). The Bill will allow the Secretary of Health to put price ceilings on and negotiate the prices of all medicines, including medically necessary assistive equipment and medical supplies purchased by the government. This measure will compel companies to price these products lower if they want to sell medicine in the Philippines, since the government is a single-payer system under the Universal Health Care Law. The bill also urges the Philippine National Drug Formulary (PNDF) to encourage the use of generics whenever possible, such as encouraging doctors to prescribe generic medicines if there are no difference between generic and branded medicines. The bill seeks to amend the existing Republic Act 9502 or the “Cheaper Medicine Law”, under which the Philippine government can set a Maximum Drug Retail Price (MDRP). Rep. Salceda said that the MDRP is still too high for poor Filipinos to buy medicine, accounting for only 10% of health expenditures nationally compared to 65% by the wealthier half of the population. See more.
  • Myanmar Replaces Home Affairs Minister; Appoints Two New Deputy Ministers
    On February 6, Chief of Military Security Affairs Lieutenant General Soe Htut was nominated to replace Lieutenant General Kyaw Swe as the new Minister of Home Affairs. Lt. Gen Kyaw Swe has resigned from his ministerial post and is expected to return to military service. The new minister-designate Lt. Gen Soe Htut is a graduate of the 64th intake of the Myanmar Officers Training School (OTS) and has led the Office of Military Security Affairs, a key branch of the Tatmadaw (Myanmar Military) involved in intelligence gathering, since 2016. Under Myanmar’s 2008 Constitution, the Defense, Home Affairs, and Border Affairs ministries are under direct control of Tatmadaw Commander-in-Chief Senior General Min Aung Hlaing, who nominates their ministers and deputy ministers. The nominations are then approved by the President and confirmed by a full vote in Parliament. On February 4, Myanmar President U Win Myint announced the appointment of U Min Lwin and U Myint Kyaing as Deputy Ministers to key Union Ministries – the Ministry of the Office of the State Counsellor (MOSC) and the Ministry of Labor, Immigration and Population (MOLIP) respectively. U Min Lwin is a career diplomat, having served in the Ministry of Foreign Affairs since January 1980. He most recently served as the Permanent Representative of Myanmar to ASEAN. He also served as Myanmar Ambassador to the Republic of Indonesia from 2012 to 2014 and was a non-resident Myanmar Ambassador for Timor-Leste from 2013 to 2015. In addition to his ambassadorial roles, he has also been posted to senior diplomatic assignments at the Myanmar embassies in Bonn, Islamabad, and Washington, DC. U Myint Kyaing, who was appointed Deputy Minister of MOLIP, is a career bureaucrat within that same ministry and most recently served as its permanent secretary. He has been taking the lead in the repatriation process of refugees who fled to Bangladesh from Northern Rakhine State.
  • Thailand Board of Investment Promotes Major Infrastructure Projects to Support Growth
    The Thai government has announced its spending target of 1 trillion baht (US$33.04 billion) in the second quarter of 2020. Capitalizing on the strong baht to promote private investment, the government spending will go toward the major infrastructure projects, especially the six key projects in the Eastern Economic Corridor (EEC). This include 2,000 kms of double track trains valued at US$1.8 billion, the US$4.47 billion Bangkok-Rayong high-speed rail to link three airports, an increase airport capacity and an expansion of Bangkok's mass transit network. In addition to funding the projects, the government also assigned the Thailand Board of Investment (BOI) to create an incentive package to promote investment by offering tax incentives and SMART visas for companies engaging with human resources development. This announcement comes after the BOI’s statement that investment promotion requests in 2019 exceeds the 750 billion baht (US$24 billion) goal, of which 59 percent or 444.88 billion baht (US$14 billion) are located in the EEC. China becomes the largest investor for the first time with 260 billion baht (US$8 billion) in investment, surpassing Japan which invested 63 billion baht (US$2 billion).
  • Vietnam to Develop 10-year Seaport Master Plan
    As Vietnam continues to build its public infrastructure, Deputy Prime Minister Trinh Dinh Dung on January 15 approved the development of the Master Plan on the National Seaport System for the 2021-2030 period. The plan will aim to implement the strategy for the sustainable development of Vietnam’s marine economy by improving infrastructure connectivity, reduce logistical costs, and promote marine economic development. The plan will also include solutions to improve the efficiency of investment in developing seaports in Vietnam and ensure synchronous development between seaports and other transport infrastructure. Particularly, the Deputy Prime Minister emphasizes the connectivity of seaports throughout the country, with seaports in other countries, with other transport infrastructure (road, railway, airport and in-land waterway system), with urban areas, economic zones, tourism zones, industrial zones and logistics center. Nguyen Van Binh, Head of the Party Central Committee’s Economic Commission has stated that Vietnam needs to optimize the seaport system efficiency, not build more seaports. In 2019, Vietnam maritime transport has had remarkable growth in key metrics. The amount of freight handled at Vietnamese ports was up 14 percent from previous year while container cargo was increased by 6 percent year-on-year. Nguyen Xuan Sang, director general of the Vietnam Maritime Administration, said that with Vietnam joining free trade agreements, the volume of goods through its ports in the coming years is expected to grow by 12-15 percent a year, and so investment to increases their capacity is urgently needed.

Current Advocacy

  • Vietnam Draft Decree on Personal Data Protection (PDP)
    On December 27, 2019, the Government of Vietnam published an outline of the draft decree on "Personal Data Protection" (PDP Decree) on its government portal (Vietnamese only; accessible at this link). They are still seeking comments for the draft and no deadline has been set. The PDP draft is currently just an outline, with most of the articles as headings. While the document claims to be based on implementing the Law on National Security of 2004 and the Law on Cybersecurity of 2018, there is very little in these laws that govern data privacy, including principles. The Ministry of Public Security (MPS) and the broader government is developing this decree from scratch, and they are open to comments and inputs from all stakeholders, especially from industry in more developed countries. While no deadline has been set for the comment period, there is an urgency to issue this decree. Without industry involvement, the Government may issue it as soon as later this year. If you have any questions, or for further details, please contact Vu Tu Thanh at and Jamie Lim at
  • Vietnam Decree on Administrative Fines for Violation of ICT Regulations
    On February 3, the Government of Vietnam (GOV) issued Decree 15/2020, ND-CP on administrative sanctions for violations of regulations on post telecommunications, radio frequencies, information technology, and electronic transactions. Please find a translated version of the Decree here, which details the various types and levels of violations and corresponding fines and additional punitive measures short of criminalization. The Decree will take effect on April 15. The Decree affects social media operators/platforms, online game service providers, cloud service providers and any company that runs or hosts a news website (Articles 98-104 on violations regarding online information). We will also be coordinating with the U.S. government in Washington, DC and the U.S. Embassy in Hanoi on this. If there is sufficient interest from members, the Council will also consider submitting a position paper to the government and MIC. For questions or to express interest, please contact Jamie Lim ( or Vu Tu Thanh (
  • Malaysia’s Draft on Medical Device Guidance Document: Notification of Refurbished Medical Devices
    On February 7, the Malaysia Ministry of Health’s Medical Device Authority (MDA) issued for public feedback a Guidance Document (accessible at this link) to help the industry and healthcare professionals to comply with the Medical Device Act (Act 737) and the regulations under it, and/or to facilitate their business endeavor. Organizations that refurbish medical devices are subject to Malaysian rules about the need to register products before they are exported or placed on the market, as well as a circular outlining the requirement for manufacturers to submit notifications to MDA for refurbishment activities. The draft guidance sets out what information MDA wants manufacturers to include in notifications.

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