Definition of a Technical Person in Charge of Medical Devices
In the fast-evolving landscape of medical technology, regulatory compliance and technical oversight have become increasingly vital. One crucial role that supports safety, quality, and compliance in the medical device industry is the Technical Person in Charge (TPIC). This professional plays a central part in ensuring that medical devices are safe, effective, and meet national and international regulations
A TPIC is more than a regulatory figure; they are a technical leader. Their presence is often required by regulatory bodies, and their qualifications, duties, and responsibilities are clearly outlined in medical device legislation in many countries. Whether working with local manufacturers, importers, or distributors, the TPIC acts as a gatekeeper for quality and compliance in the healthcare technology supply chain.
Definition of a Technical Person in Charge of Medical Devices
A Technical Person in Charge (TPIC) is a qualified individual designated by a medical device company to oversee compliance with technical and regulatory requirements. The TPIC ensures that all medical devices handled by the organization adhere to applicable safety, performance, and documentation standards.
This role is recognized by many national health authorities, including those in the European Union, the United States, and several Southeast Asian countries. In many jurisdictions, companies cannot obtain or maintain a medical device license without designating a qualified TPIC.
Importance of the TPIC Role in the Medical Device Industry
The TPIC plays a critical role in protecting patient safety and public health. Their technical oversight helps prevent the distribution of faulty, substandard, or unapproved medical devices.
Additionally, having a qualified TPIC ensures that companies are better equipped to navigate complex regulatory frameworks. The TPIC’s knowledge of documentation, testing protocols, and risk management contributes significantly to a company’s operational excellence and reputation.
Required Qualifications for a TPIC
To be eligible as a TPIC, candidates typically must have a background in science, engineering, or healthcare. In many countries, a minimum of a bachelor’s degree in a relevant field—such as biomedical engineering, pharmacy, or medical technology is required.
In addition to academic qualifications, experience is crucial. Many regulatory bodies require at least 2–5 years of hands-on experience in manufacturing, quality assurance, regulatory affairs, or medical device management. Certifications in Good Manufacturing Practices (GMP), ISO 13485, and risk management are often considered advantages.
Key Responsibilities of a TPIC
A TPIC’s responsibilities may vary depending on company size and regulatory requirements, but commonly include:
- Ensuring compliance with national and international regulations
- Overseeing product registration and documentation
- Monitoring post-market surveillance activities
- Approving product labels and instructions for use
- Participating in audits and inspections
- Coordinating with regulatory authorities
These tasks require deep technical knowledge as well as strong communication and organizational skills.
TPIC and Product Registration Process
One of the main roles of a TPIC is to facilitate the product registration process. The TPIC must ensure that all required documents, such as technical files, clinical evaluations, and risk assessments, are complete and accurate.
The registration process is highly documentation-heavy. A TPIC must maintain a thorough understanding of submission formats, electronic reporting tools, and timelines. Failure to meet regulatory expectations during registration can lead to delays or rejections.
TPIC’s Role in Quality Management Systems
A TPIC is instrumental in implementing and maintaining a robust Quality Management System (QMS), often aligned with ISO 13485 standards. This includes ensuring proper documentation, conducting internal audits, managing corrective and preventive actions (CAPA), and overseeing training for staff.
By playing a key part in the QMS, the TPIC helps companies produce safe and consistent medical devices, reduce recalls, and build regulatory trust.
Regulatory Expectations Across Different Countries
Regulatory expectations for TPICs vary by region. In the European Union, the MDR (Medical Device Regulation) emphasizes the need for a “Person Responsible for Regulatory Compliance” (PRRC), which is similar to the TPIC.
In countries like Indonesia, Malaysia, and Singapore, a TPIC must be officially registered and approved by the national health authority. Each country outlines its own criteria, including academic qualifications, years of experience, and scope of responsibilities.
Challenges Faced by TPICs
Working as a TPIC comes with its own set of challenges. Keeping up with constantly changing regulatory requirements can be overwhelming. Furthermore, ensuring coordination between departments—such as production, R&D, and regulatory affairs—can be complex.
Another common challenge is managing multiple product portfolios while ensuring timely submissions and updates. The TPIC must be organized, detail-oriented, and adaptable to evolving regulatory landscapes.
Role of TPIC in Post-Market Surveillance
Once a product is on the market, the TPIC continues to play a vital role. Post-market surveillance (PMS) involves tracking the performance and safety of a medical device in real-world conditions. The TPIC must review feedback, incident reports, and product complaints to identify risks and take corrective actions if needed.
In many jurisdictions, PMS is a legal requirement. The TPIC ensures that reporting to the health authority is timely, complete, and aligned with applicable guidelines.
TPIC in Import and Distribution of Medical Devices
When medical devices are imported, a TPIC ensures that the devices meet local regulatory standards before distribution. This includes checking product labeling, verifying import licenses, and ensuring customs documentation is in order.
In the case of distributors, the TPIC oversees that only registered and approved products are circulated, thus protecting the safety of end users and maintaining the company’s legal standing.
TPIC’s Role in Product Recalls and Field Safety Actions
In the event of a product recall or field safety corrective action (FSCA), the TPIC takes the lead. Their responsibilities include investigating the root cause of the issue, notifying the health authorities, and coordinating communications with healthcare providers and users.
Proper handling of recalls not only ensures public safety but also protects the company from legal liabilities and reputational damage. The TPIC is expected to act swiftly and document all actions thoroughly.
Collaboration Between TPIC and Other Departments
To be effective, a TPIC must work closely with other departments such as R&D, regulatory affairs, legal, and customer service. This cross-functional collaboration ensures that all aspects of the medical device lifecycle—from design to post-market activities—are properly managed.
A proactive TPIC often participates in design control meetings, risk assessments, and even marketing reviews, ensuring compliance is embedded in every stage of the product life cycle.
Continuous Learning and Certification for TPICs
Given the rapid development of technology and regulations, continuous professional development is essential for TPICs. Attending workshops, seminars, and certification courses in regulatory affairs, quality systems, and clinical evaluations helps them stay up-to-date.
International certifications such as RAC (Regulatory Affairs Certification) or specialized QMS auditor certifications are valuable credentials that enhance a TPIC’s credibility and career prospects.
Digital Tools Supporting TPIC Functions
Modern TPICs often rely on digital tools to manage documentation, track regulatory submissions, and monitor post-market feedback. Tools like Electronic Document Management Systems (EDMS), Regulatory Information Management Systems (RIMS), and complaint handling software improve efficiency and accuracy. Utilizing technology helps TPICs manage large volumes of data, stay audit-ready, and reduce compliance risks.
Ethical Responsibilities of a TPIC
Beyond legal obligations, a TPIC also has ethical responsibilities. They are entrusted with safeguarding public health and must act with integrity, honesty, and objectivity. Any attempt to hide, delay, or manipulate data can have serious consequences for patients and the company. A strong ethical compass is essential for making decisions that prioritize safety over convenience or commercial gain.
TPIC in Small vs. Large Companies
The scope of a TPIC’s work can differ significantly depending on the size of the organization. In small companies, the TPIC may wear multiple hats—handling both technical and regulatory functions. In larger companies, their role may be more focused, but also more specialized. Regardless of company size, the TPIC remains a cornerstone in maintaining medical device safety and compliance.
Future of the TPIC Role
As regulations become more sophisticated and digital health products grow in number, the TPIC’s role is expected to expand. Areas such as software as a medical device (SaMD), cybersecurity, and artificial intelligence are emerging fields that require specialized oversight. TPICs who adapt and evolve alongside these trends will remain valuable assets in the future of healthcare technology.
The Technical Person in Charge of medical devices is a key figure in today’s regulatory landscape. Their responsibilities span technical, regulatory, and ethical domains, making them indispensable in ensuring the safety and effectiveness of medical devices.
Companies that invest in capable TPICs not only meet regulatory requirements but also demonstrate a strong commitment to quality and patient safety. As the industry evolves, the TPIC will continue to serve as a crucial bridge between innovation and compliance.
Contact Naramedic for further consultation.