International and domestic medical device registration services
All regions medical device registration services
Taiwan medical device registration services
QSD (Quality System Documentation)
QSD Introduction
QSD is the abbreviation of Quality System Documentation. Prior to importing medical devices into Taiwan market, the quality system of foreign manufacturers of medical devices must comply with Good Manufacturing Practices (GMP) for medical devices.
QSD is one of the methods for medical device importers to apply for compliance with medical device GMP. The dealer or distributor who hold the drug dealer license should submit an application to the Food and Drug Administration of the Ministry of Health and Welfare. Any sterilized or measured first-class, second-class and third-class medical devices are those items needed to apply for QSD.
QSD requires submission documents
QSD requires submission documents which will be different depending on the country of the manufacturer and provided with the various applications. In accordance with the provisions of Article 7 of the “Measures for the Inspection of Drug Manufacturers”, the documents are submitted for reviewing must be all attached. You could refer to the Food and Drug Administration to prepare relevant documents as required.
Medical product inspection and registration
What is product inspection and registration? Which agency should I approach for application?
Prior to the medical device is launched into Taiwan market for safety concern, effectiveness and intended use, it must comply with the regulations of the Taiwan Food and Drug Administration of the Ministry of Health and Welfare (hereinafter referred to as the Food and Drug Administration) for medical device inspection and registration to obtain a official medical device license.
According to Article 40 of the Pharmaceutical Affairs, either manufacture or import medical equipment should apply for inspection and registration and the medical equipment license can only be manufactured or imported after approval and issuance of a medical equipment license.
How to apply for a medical device license?
The drug dealer who holds a drug dealer license should submit an application to the Food and Drug Administration of the Ministry of Health and Welfare.
The period of validity of the medical device license is 5 years. Those who still need to continue manufacturing and importing after the expiry date shall apply for an extension in advance and each extension shall not exceed more than 5 years. Those who fail to apply within the time limit will be no longer to get the permission.
Furthermore, the medical device manufacturers would like to apply for inspection and registration must refer to the contents of Annex 1 of the “Medical Device Management Measures” to determine the classification and grading of products. If they cannot determine for uncertain reason, then need to fill in the medical device attribute management query (assisted determination system). Medical devices can be divided into non-in-vitro diagnostic (NIVD) medical devices and in-vitro diagnostic medical devices (IVD), as well as divided into Class I and Class II/III according to the degree of risk. After grading and classification, complete the application, prepare relevant application materials and review fees, then submit an application to the Food and Drug Administration. The medical device license will be issued after approval accordingly.
Southeast Asia medical device registration services (Including Indonesia)
The reality is…. The regulatory systems of various countries in Southeast Asia look similar, but they are actually quite different.
What can we do? What is the registration process for ASEAN CSDT in Southeast Asia?
How can we do? Every country in Southeast Asia has a different language. How to apply?
What is ASEAN CSDT?
ASEAN CSDT proposed the ASEAN CSDT format in the ASEAN Medical Device Directive (AMDD; ASEAN Medical Device Directive), which is composed of Southeast Asia ten countries Signed by : the Philippines, Malaysia, Singapore, Thailand, Brunei, Vietnam, Myanmar, Laos, Cambodia and Timor-Leste.
CSDT aims to coordinate the information submitted for premarket registration of medical devices and simplify technical documentation activities for all manufacturers planning to step into multiple Southeast Asian countries. The CSDT template is applicable to general medical devices and in vitro diagnostic medical devices; AMDD requires CSDT technical documentation to be provided in English, unless requested by Southeast Asian Member States (AMS; ASEAN Member States) in any other local language.
The depth and details of the information contained in CSDT will depend on the classification and complexity of the device. Therefore, the correct definition of the classification system will affect the types of records required for registration, costs, and important time to achieve registration. The process of classifying and binding medical devices is very challenging and requires in-depth understanding, as it will help to successfully register or file.
In addition, it must be noted that all foreign manufacturers must now obtain compliance assessment certification from any designated agency (CAB) recognized by AMS in order to obtain approval from AMS regulatory authorities for product registration applications, unless the medical device has been exempted from registration requirements. If the manufacturer’s product has already been certified for compliance with MDSAP in the United States, the European Union, Australia, or Canada (such as ISO 13485), CAB may simplify the review process.
What we can do is more than the registration services! We could provide you more local resources to connect the referral markets and assist you in stepping on the right path!
In those diverse and complex Southeast Asian countries, in addition to consider the regulatory submissions process more efficiently, any foreign medical devices manufacturers must appoint a local representative or find a suitable agent to process the local regulatory affairs.
Our experienced professional team could provide complete one-stop consulting including comprehensive business strategy for local market, agent matching, the required documents review services and all local information interface, including complex local language translation and etc.
It allows you to obtain the registration qualification of medical equipment in Southeast Asian countries market and successfully obtain the admission to start your local business as quickly as possible!
US FDA medical device registration services
Can't understand the complicated US FDA regulations? PMN 510(k) or listing only?
How can we do? Want to apply for 510(k) but don't know what documents to prepare.
What can we do? What is the registration process for US FDA 510(k)?
The US Food and Drug Administration requires medical device manufacturers and distributors to register their production and declare medical devices with the FDA every year (Title 21 CFR Part 807).
The U.S. Congress also authorizes the FDA to collect medical manufacturer registration fees annually and most medical device manufacturing companies must also declare their medical products and devices while registering their production facilities. If it is a new medical device (“news” here means new technology, features, application which does not belong to “me too “products), the regulatory requirements need to be reviewed before listing and the manufacturer needs to submit 510(k), PMA, PDP, HDE and other documents for review. In addition to exemptions, the Medical Device User Fee Modernization Act (Medical Device User Fee Modernization Act) requires all manufacturers to pay fees on the website for annual registration.
Annual registration and medical device declaration allow FDA to grasp the business of medical device manufacturers and the country and city where they are located. With this information, FDA can response effectively when major medical device incidents are abnormal or in emergencies, such as product deactivated, disabled, recalled or destroyed.
Premarket Notification (PMN, also known as 510(k)) is issued by the Office of Device Evaluation (Office of Devices) of the Center for Devices and Radiological Health (CDRH) of the FDA. Evaluation, ODE) and Office of In Vitro Diagnostics and Radiological Health (OIR) are responsible for the review.
What we can do is more than the registration services! We could provide you more local resources to connect the referral markets and assist you in stepping on the right path!
Our experienced professional team could provide complete one-stop consulting including comprehensive business strategy for local market, agent matching, the required documents review services and all local information interface and etc. It allows you to obtain the registration qualification of medical equipment in USA market and successfully obtain the admission to start your local business as quickly as possible!
Japan PMDA medical device registration services
Everyone says that Japanese regulations are complex and have a long process, is this true? The reality is…. Japan PMDA medical device registration has their own defined process, and it must follow.
What if you don’t know Japanese? I heard that the application process must be in Japanese. The reality is…. Yes, all the application process must be in Japanese, as well as some major documents need to follow.
What can we do? What is the registration process for Japan PMDA medical device registration?
Manufactures that design, manufacture and sell medical devices outside Japan must follow the “PMD Act” (Pharmaceuticals and Medical Devices Act) that was effective since November 25, 2014.
“PMD Act” is under the responsibility of MHLW (Japan’s Ministry of Health, Labor and Welfare, Ministry of Health, Labor and Welfare) and together with PMDA (Pharmaceuticals and Medical Devices Agency, Pharmaceuticals and Medical Devices Agency) which provide medical equipment, in-vitro diagnostics (IVD), drugs, a regulatory framework for cosmetics, renewable/cell/gene therapy and other products that covering pre-market application/certification/approval, factory registration, Japan representative (Designated Marketing Authorization Holder, DMAH), quality management system, post-market safety monitoring, etc. to ensure the safety of Japanese nationals.
What we can do is more than the registration services! We could provide you more local resources to connect the referral markets and assist you in stepping on the right path!
In fact, Japanese regulatory submissions are complicated, lengthy and most difficult in the Asia Pacific region. Any foreign manufacturers want to sell medical devices into Japan market must assign a local representative or find a suitable agent. It would be preferably having relevant experienced team to be responsible for submitting various complex documents required for the registration process.
Our experienced professional team could provide complete one-stop consulting including comprehensive business strategy for local market, agent matching, the required documents review services and all local information interface and etc.
It allows you to obtain the registration qualification of medical equipment in Japan market and successfully obtain the admission to start your local business as quickly as possible!
EU MDR medical device registration services
Everyone says that the conversion of EU regulations to MDR is complicated, and the process takes a long time? Is this true? The reality is…. MDR requirement is getting stricter and more complicated, and it must follow.
What can we do? What is the registration process for MDR?
How to convert MDD to MDR? How is it different from the previous CE system?
On May 5, 2017, the Official Journal of the European Union officially released the EU Medical Device Regulation (EU) 2017/745, referred to as “MDR”. The purpose of the regulation is to ensure better protection of public health and patient safety. MDR will replace Directives 90/385/EEC (Active Implantable Medical Device Directive) and 93/42/EEC (Medical Device Directive).
According to the requirements of MDR Article 123, MDR came into effect on May 26, 2017, and officially replaced MDD (93/42/EEC) and AIMDD (90/385/EEC) on May 26, 2020.
From the date of application, all medical devices newly placed on the market in the EU must comply with the requirements of the MDR.
In April 2017, the European Union announced the MDR and IVDR, and gave manufacturers, governments and related units a three-year transition period to respond to the innovation bill. It has been decided that the Act will be enforced in May 2020. The market will no longer accept any certified manufacturers that only follow the MDD (if there is a manufacturer that has obtained the MDD before then) after May 2025. On the contrary, whether it is a new company or an existing company, it must target MDR and obtain certification before it can sell its own medical products in the EU.
Remarks: the real situation is that due to the global covid epidemic in 2020, the implementation of MDR was postponed. Hence, the official implementation date is May 26, 2021.
1. The difference between the MDR regulation and the previous MDD directive is mainly analyzed in the following aspects:
1) The responsibility of the manufacturer is strengthened:
i. The manufacturer must have at least one person in charge of compliance with professional knowledge in the field of medical devices.
ii. Manufacturing Suppliers should establish and continuously update technical files and continue to update technical files to ensure that they can be provided when required by relevant state units.
2) Increased regulatory provisions and stricter certification review.
3) Expanded scope of application.
4) MDR requires higher transparency and traceability.
2. MDR regulatory framework The MDR remittance framework is divided into 10 chapters and 123 articles, and there are 17 more appendixes.
These ten chapters respectively represent:
- Chapter I (Articles 1-4): Scope of Application and Definition.
- Chapter II (Articles 5-24): Medical Materials Putting into the Market, Responsibilities of Each Operating Body, Reprocessing, CE Marking, free circulation of products.
- Chapter III (Articles 25-34): Product traceability, operator registration of medical materials, summary of safety and clinical performance SSCP, EUDAMED.
- Chapter IV (Articles 35-50): Third Party Verification Agency (also known as Notify Body)
- Chapter V (Articles 51-60): Classification of Medical Materials and Compliance Evaluation
- Chapter VI (Articles 61-82): Clinical Evaluation and Trials (Clinical is definitely a key part of MDR. MDR incorporates more clinical requirements and is highly likely to require more evaluations, reports, and even trials compared to MDD manufacturers)
- Chapter VII (Articles 83-100): Post Listing Supervision, Vigilance, and Market Supervision
- Chapter VIII (Articles 101-108): EU Member States Cooperation, Medical Device Coordination Group (MDCG), Expert Group, Medical Materials Registration Database, etc.
- Chapter IX (Articles 109-113): Confidentiality, Data Protection, Funding, and Punishments
- Chapter X (Articles 114-123): Final Regulations, including some other relevant provisions
Our experienced professional team could provide complete one-stop consulting including comprehensive business strategy for local market, agent matching, the required documents review services and all local information interface and etc. It allows you to obtain the registration qualification of medical equipment into EU market and successfully obtain the admission to start your local business as quickly as possible!
Quality Management System
GDP (Good Distribution Practice)
What is the medical equipment GDP (Good Distribution Practice)?
Taiwan’s Medical Devices Act has promoted the management of medical equipment to international, the requirement of establishing a good logistic and marketing standards system is one of the key points of this reform. The Medical Devices Act is extending the concept of “quality system” to dealers for establishing the management structure more comprehensive and also expected that the “Good Distribution Practice (GDP)” will be more in line with the international quality management of medical equipment throughout the life cycle.
The establishment of the Good Shipping and Marketing Guidelines for Medical Devices (referred to as “Medical Devices GDP”) aims to establish the management of the medical materials, source and product usage to ensure the product quality meets the requirements of the original manufacturer in the process of storage, transportation, distribution and sales of medical devices. So as strengthening the implementation of the management of product traceability and related procedures outsourcing to provide high-quality medical devices for the public.
Who needs to apply for medical equipment GDP?
According to “Article 24 of the Medical Devices Act”,
“The medical equipment and its dealers (currently 45 items in total will be effect from May 1st 2023) announced by the government authority shall establish an excellent logistic ,storage, services, staffing and other related operations to comply with the excellent logistic and marketing standards for medical equipment. “
“The excellent logistic and marketing standards referred to in the first paragraph, the contents and methods of inspection referred to in the preceding paragraph, the conditions, procedures, examination, issuance, validity period, change, revocation or annulment, and other matters to be observed shall be prescribed by the central competent authority.”
What are the benefits of medical equipment GDP？
To ensure that the process of logistic, storage and sales of products are eligible and being recorded precisely, this management system will thoroughly cover the entire life cycle from design, manufacturing to selling into market.
Other important Q&A related to GDP including application process, you could refer to https://www.fda.gov.tw/TC/siteContent.aspx?sid=11572 for more detailed explanations.
In addition, there are 45 types of medical equipment which will require GDP from May 2023 in the first phase.
Please also refer to https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=26852.
We provide GDP application and warehousing planning that you could easily comply with the upcoming medical equipment GDP related processes.
Digital Health
In response to the needs of the market and customers, we are developing digital medical clinical services to assist various clients to complete their medical research, clinical needs and registration. Except the common IoT devices, SaMD (Software as medical device) is also a major topic of discussion and can help medical software /AI companies to give appropriate assistance and consultation in the process of product development.
This may comply efficiently with the domestic and international regulations and registration.
The reform of international regulations on digital health is developing rapidly.
The reform of international regulations on digital health is developing rapidly. However, the medical care usually involves personal safety and most of countries have begun to formulate relevant regulations to manage the possible risks caused by digital health care. With the more application of high-speed network, big data, digital medical products of artificial intelligence and software, many countries have begun to promote the integration of digitalization and wireless transmission of medical care and materials. The traditional medical device manufacturers have tried to add detection equipment, software, connection, data functions and gradually approach the field of digital medical care to enhance the product value.
Domestic and international digital medical device laws and regulations reform is aimed at the development of digital medical devices. Since medical devices used to be regulated only by the Pharmaceutical Affairs Law, their development has become more diversified. Therefore, at the end of 2017, the Executive Yuan R.O.C. proposed the draft “Medical Device Management Act” as the basis for medical device management but the draft is still under discussion in the Legislative Yuan. However, considering the continuous generation of innovative medical materials produced by digitalization and other countries have gradually established relevant policy and legal frameworks for this irreversible trend. Therefore, the Food and Drug Administration of the Ministry of Health and Welfare also simultaneously conducted a preliminary study on digital medical related medical equipment in 2018 to evaluate the direction of policy research from the development trend of digital medical and smart medical equipment management in various countries.
Based on the legal issues arising from the application of emerging technologies such as artificial intelligence, the Internet of Things (IoT) and blockchain, it is important to use those tools to collect, process, utilize and even make decisions on the information required for digital medical care. However, these emerging technology applications may be cross-regional, cross-organizational and whether the authorization of medical or health data collected or exchanged complies with local regulations and whether the subsequent processing of the data complies with the requirements of privacy and de-identification, or whether to allow the data of the parties to be removed from the data analysis database and other rights issues may also be the focus of regulatory considerations. In addition, if the application of digital medical care has involved decision-making recommendations, responsibility definition and ethics will also be new issues. For example that Japan has currently formulated AI medical rules to clearly define responsibilities. Hence those issues listed as above will also become a significant concern in the regulatory environment.
Contact us
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