In brief
Under the current regulation, a Good Manufacturing Practice (GMP) certificate obtained from the Food and Drug Administration (FDA) is a voluntary requirement for local medical device manufacturers. However, manufacturers of licensed medical devices and detailed notification medical devices must provide GMP certificates from the FDA or an ISO 13485 certificate issued by one of the official Certified Bodies as part of the documents for the registration of medical devices. These certificates are not required to manufacture and notify low-risk medical devices unless they are exported and certain certificates are required by the destination countries.
It is expected that the FDA will announce the GMP regulations in 2022 or early 2023, which will require new manufacturers to obtain either GMP certificates from the FDA, ISO 13485 certificates from official Certified Bodies, or other equivalent certificates pre-approved by the FDA. Grace periods will be given to existing manufacturers, i.e., two years for licensed medical devices, three years for detailed notification medical devices, and four years for low-risk medical devices or by 2027.
The GMP regulations will not apply to local manufacturers of medical devices which already have specific quality systems such as blood bags, condoms, surgical gloves or medical devices for export only.
Author
Peerapan Tungsuwan
Peerapan is a Corporate and M&A partner and heads the Sustainability Group and Healthcare & Life Sciences Industry Group in Bangkok. She also co-heads the Investigations, Compliance & Ethics Practice Group in Bangkok and is currently a member of the Firm's Global Executive Committee. Peerapan has nearly 40 years of experience advising on transactional and regulatory matters in highly regulated industries. Peerapan is exceptionally fluent in regulatory matters relating to healthcare, consumer protection and product liability.
Peerapan also has extensive experience advising on compliance issues, risks facing companies across various industry sectors, and regularly assists clients in practically managing and mitigating those risks. She has been consistently recognized as 'Leading Individual’ in Corporate M&A by the Asia Pacific Legal 500 for eight consecutive years (2013-2020) and has been inducted into the Asia Pacific Legal 500 Hall of Fame in Corporate M&A in 2020-2023. More recently she has been shortlisted for Corporate and M&A Lawyer of the Year by the Legal 500 Southeast Asia Awards. Peerapan was also awarded ‘Client Choice winner’ for Healthcare & Life Sciences 2019 by Lexology.
In October 2022, Peerapan was elected to join the Global Executive Committee and serve as chair of the Asia Pacific region. In this role, Peerapan works alongside the Firm's leadership to drive forward the Firm’s business strategy and prioritized actions.
Author
Panyavith (Taro) Preechabhan
Panyavith assists major local and multinational clients in a range of heavily regulated industries, such as healthcare & life sciences, chemical and biotech, on large complex mergers and acquisitions, private equity transactions, joint ventures, corporate restructurings, post-acquisition integration projects, commercial agreements and regulatory issues. With his technical and commercial astute, Panyavith has often been involved in a number of pioneering projects, helping clients navigate the challenges of uncharted waters and emerging opportunities with innovative solutions.
He is recently recognized as "Up and Coming for Corporate and M&A" in Thailand by Chambers Asia-Pacific 2023.
