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MDSAP is a certification system established by the International Medical Device Regulatory Forum (IMDRF) for joint review for safety and quality management of medical device according to the international standards. It is jointly operated by 5 members of IMDRF: United States, Canada, Australia, Brazil, and Japan.

For a medical device manufacturer that has MDSAP certificate, only 5 countries: US (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA) are fully or partially exempted from certification review. This single review will save time and cost by complying with regulatory requirements of the selected country.

IMDRF is a council of regulating authorities established to integrate medical device regulations, and leading the level and direction of medical device regulation around the world since 2011. In 2017, Korea joined IMDRF as an 10^th official member, following the US, EU, Canada, Australia, Japan, China, Brazil, Russia, and Singapore.

Currently, MDD was abolished in 2017 according to MDR 2017/745 through many changes and customer-oriented thoughts and MDR has been newly established.

The MDCG guideline has been constantly enacted regarding MDR so far, thus you must understand all new regulations before proceeding.

1. Major details

Reinforce risk control

A. Obligation of periodic safety information update report (PSUR) 

B. Reinforce requirements for Carcinogenic, Mutagenic or Toxic for Reproduction (CMR) 

C. Participation of expert panelS in clinical evaluation review for Class IIb and Class III, except for certain devices

Establish EUDAMED, a database at European Union Level 

A. Register UDI, manufacturer and European agents, certification service and certificates, clinical trials, post-marketing vigilance, and follow-up information

※ Reinforce and continuously update technical document requirements

A. All design/development data required by EN ISO 13485 

B. Monitoring/inspection/test criteria and methods of manufacturing process (including SOP) 

C. List of all suppliers, products and services provided by each supplier and their certificates, supervision plan for major suppliers, and supply contract

※ Clinical trial requirements which represent European population for implantable and high-risk group 

For implantable devices or Class III devices, submit a clinical trial report with the established logic to represent the European population except for certain devices

Medical Device Quality Management System Certification Specification, ISO 13485

ISO 13485 : Specifies the requirements of the quality management system to demonstrate an ability of an organization to provide legitimate medical devices and regarding services applicable to customer needs and medical devices and regarding services in 2003.

The major purpose of ISO 13485 is to facilitate the medical device regulations integrated with the quality management system. Accordingly, certain requirements for medical devices shall be included and some other requirements of ISO 9001 not in compliance with the regulations shall be excluded. Even if an organization’s quality management system complies with ISO 9001 specification for this exception, the organization in compliance with ISO 13485 can’t claim that it is also in compliance with ISO 9001 specification.

All requirements of ISO 13485 specification are specific to an organization supplying medical devices regardless of size and type of the organization and if regulatory requirements allow the exclusion of design development control, the exclusion may be justified from the quality management system. However, the exclusion of the design development control is reflected and compliance with ISO 13485 specification is responsibility of the organization.

The benefits of ISO 13485 certification are as follows. 

Enter overseas markets with the corresponding certification 

Reduce operating cost by identifying process defects and improving efficiency 

Provide good quality in an organized way and increase customer satisfaction by addressing customer complaints 

Demonstrate commitment to providing quality through the international standards

Transparency in handling customer complaints, follow-up, and recall

Facilitate entering into Asian countries in addition to CE countries  

European agent (Authorized Representative) is a natural or legal person within EC region, expressly appointed by a manufacturer, who acts on behalf of a manufacturer regarding obligations of the manufacturer under this guideline and contact with authorities and certification services within EC.

According to the guideline for European agent (GUIDELINE FOR AUTHORISED REPRESENTATIVES – MEDDEV 2.5/10), responsibility of a manufacturer does not change, but selection of the European agent must be accurately assigned and monitored by the manufacturer.

The European agent does not simply act as a contact point for matters incurred from Europe on behalf of manufacturers of medical devices in countries other than Europe, however, the agent is obligated to receive information from the manufacturer regarding registration of medical device products in the European agent’s country and management of history of sales in the European medical device market.

According to the medical device law published in September, 2012 (Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009), the European agent is required to have at least one experienced person within the company who has specialized knowledge of legal requirements regarding European medical devices.

Accordingly, when selecting the European agent, the agent must understand the legal requirements of medical devices rather than simply acting as a contact point and a company to be appointed is required to have experience in registering CE marked products in the applicable country.

U.S. FDA Medical Device 510(k) Approval

510(k), also called Pre-marketing Notification (PMN), is the article number of the U.S. Food, Drug, and Cosmetic Code that specifies that manufacturers who are required to register information with the US government shall provide notification at least 90 days prior to placing a product on the market.

The US Food and Drug Administration (hereinafter, US FDA) divides the products notified through this regulation into 3 grades and identifies whether it is the same product as a medical device that has been released on the market or a new medical device that has never been released.

More specifically, medical device manufacturers must perform pre-marketing notification prior to initial commercial distribution of a product or prior to distribution of an approved product where major change has been made to the extent that it affects the safety and efficacy/effectiveness of the product. This major change include changes in product design, materials, chemical composition, energy sources used, production procedures, or intended use.

[U.S FDA 510(k)]

510(k) submission process

Introduction

For the document submitted for pre-marketing notification (510(k)), the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR) comprising of biomedical engineers, physicians, microbiologists, chemists, and other medical device experts, from the departments of the US FDA’s Center for Device and Radiological Health (CDRH), will review. 

Access and Application Notice Process

Applicants for 510(k) should submit two copies of the documents to CDRH’s Document Control Center (DCC) at the address: 

Food and Drug Administration Center for Devices and Radiological Health Document Control Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, Maryland 20993-0002 

One of the two copies shall be submitted electronically.

When the DCC receives 510(k) submission, a unique number is assigned to the document. Generally, this number is referred to as “510(k) number” or “K number.” This K number consists of six numbers followed by the letter K. The first two digits indicate the year of submission, and the last four digits indicate the order of submission in that year. In other words, the first submitter of the year is assigned 0001, and higher numbers are assigned as the order continues.

After submission, the DCC will check the following 2 items upon receipt.

- Receipt of the application fee  

Note: The submission fee of 510(k) is charged by the date that the US FDA receives the document, not the date the submitter sends it. 

- Confirmation of the electronic copy received 

If there is a problem with reasonable beneficiary fee or receipt of the electronic copy, the DCC will send a suspension notice to the 510(k) submitter within 7 days of receipt. The submitter shall resolve any problems related to the beneficiary fee or receipt of the electronic copy within 180 days from the date of sending of the suspension notice. If not resolved within 180 days, the 510(k) submission will be invalidated and deleted from the system. The submitter shall reapply through a new application process.

[510(k) Confirmation]

The US FDA’s deadline officially set for 510(k) process is 100 days. This is calculated from the date the US FDA receives the document to the final decision, except during the period in which such submission is under suspension due to a request for additional information. The final decision may be either Substantially Equivalent (SE) or Not Substantial Equivalent (NSE).

Upon final decision, the US FDA will issue a decision and sends it to the email address specified in the submission. 

The submission determined to be Substantially Equivalent (SE) is considered to be “approved.” The approved 510(k) submission will be registered in the US FDA’s 510(k) database which updates weekly. 

FDA Receives 510(k) Submission.

 

[Medical Device Registration and Notification]

US FDA registration of company and product

An owner or operator of the business (facility or equipment) involved in production or distribution of medical devices intended for use in the US shall register the business in the US FDA annually, and this process is called the facility registration process.

The US Congress authorized the US FDA to collect annual fee from the businesses. For more information of the businesses responsible for registration and fee, please see “Medical Device User Fee Amendments (MDUFA).”  

Any business outside the US involved in manufacturing, packaging, proliferation, compounding, or processing of any medical device imported into the US shall appoint its US agent.

Responsibilities of US agent

The US. agent may be a resident or business owner in the US, however, must not use a post office box address. Additionally, the US agent must not use an answering machine only and must be available to answer calls directly or through an employee during normal business hours.

The responsibilities of US agent are limited to the followings: 

Support communication between the US FDA and overseas business 

Respond to questions regarding products from overseas business imported or proposed for import into the US

Assist in scheduling of overseas business review 

When the US FDA is unable to directly contact an overseas business, any information or document to be delivered may be sent to the US agent. This is considered as if the information or document was directly sent to the business.

Pursuant to the Medical Device Notification Regulations (21 CFR Part 803), the US agent is not liable for medical malpractice or 510(k); obligation of pre-marketing notification process (21 CFR Part 807, Subpart E).

MTGS (Medical Total Solution Solution) will provide interpretation and translation services with our experiences in completing different projects.

MTGS (Medical Total Solution Solution) will provide the best interpretation and translation services for bio, medical device, GMP, and review, with our experiences in completing different projects.

In order to issue a test report of electrical and mechanical safety test (IEC 60601)

Risk Management Report

Software Validation Report 

Usability Engineering Report are needed.

MTGS (Medical Total Solution Solution) will provide a test support service with our experiences in completing different projects