Regulatory Affairs

Regulatory Affairs

Regulatory documentation and support worldwide

Whether it's the dreaded Form 483 from the FDA, often very complex procedures in the APAC region, a confusing obstacle course of GB and YY standards in China, or the complex market in the Middle East and Africa, there is an expert at qtec who knows the answer to your question - and can design a solution to your problem.

Regulatory documentation and support worldwide

Whether it's the dreaded Form 483 from the FDA, often very complex procedures in the APAC region, a confusing obstacle course of GB and YY standards in China, or the complex market in the Middle East and Africa, there is an expert at qtec who knows the answer to your question - and can design a solution to your problem.

Table of contents : Regulatory documentation and support worldwide

North America

The US-American FDA has the reputation to be one of the strictest authorities for Medical Devices and the required on-site inspections are often feared. We are happy to help; we will show you what deficiencies the inspectors are looking for, and that these FDA inspectors are not to be feared.

Challenges with the FDA registration for Medical Devices- Sound familiar?

You are looking to conquer the US-American market with your innovative Medical Device, but you are hesitant because of the well known dreary, long and costly process that is associated with the FDA?

Do you have an FDA inspection coming up and you're afraid of discrepancies because they will be published and come with high costs?

Or you have already received a warning letter and are now aware that you cannot make any more mistakes?

The FDA presents the European manufacturers with many challenges:

  • High requirements on software, cybersecurity and biocompatibility
  • There are often new guidelines that must be followed
  • Apparent arbitrariness and unjustifiable rigor in decisions by inspectors and reviewers
  • Tough and expensive consequences in case of nonconformities right up to bans on imports

And when it comes to the serious case of an inspection:

The 510(k) Clearance or the PMA approval alone, are not sufficient. Besides the product testing, the quality management system will also be assessed. We will design a quality management system according to the 21 CFR part 820 conform; which will not allow any possible attacks. Thanks to many years of experience, our experts know what FDA inspectors look for.

We will prepare, and accompany you - in both the Front or Back-Office - and will take care of the follow-up. We also eliminate identified discrepancies created with the dreaded Form 483. Furthermore, we will support you in the Processing of non-conformities that were not identified during an inspection, and arrive in the form of a warning letter.

 

The right process for the approval of medical devices in the USA can decide the amount of effort that you will have to face. No matter if De Novo, 510(k) or PMA: we have already successfully completed and supervised numerous approvals within the FDA, and will bring your Medical Device with minimal cost and time overseas.

Contact +49 451 808 503 60

Canada

We also have experts for approval with the "small" North American neighbor Canada. We can help you in areas such as:

  • classification of your Medical Device under Canadian law
  • setting up an ISO 13485 and MDSAP compliant QM System
  • obtaining the Medical Device Establishment License (MDEL) or the Canadian Medical Device License (MDL) for your Class II to IV devices
  • Creation of the Premarket Review Document
 

Are you planning an initial market access and do not yet have MDSAP certification? Or have problems with the new approval of devices via the License Applications or License Amendments for Class II to IV? Our experts will support you purposefully.

Contact +49 451 808 503 60

APAC - Asia-Pacific Economic Area

The abbreviation APAC stands for the Asia-Pacific Economic Area, which comprises the regions in Asia, Australia and Oceania. Especially for manufacturers of Medical Devices, the following countries are economically valuable:

  • Australien
  • Japan
  • South Korea
  • Singapore
  • Malaysia
  • Taiwan
  • India
 

Is an MDSAP an imminent requirement for approval in australia? Do you know which obligations you have to fulfill if you want to place Medical Devices on the market in Japan? Or Korea? We do ... Our experts know the score in these regions and networks; and are eager to support you.

Contact +49 451 808 503 60

China

With almost 1.4 billion people, the Chinese market is by far the largest in the world. It attracts large sales, but cannot be conquered overnight. Language barriers, long approval times and non-transparent decisions are just some of the challenges that European manufacturers of Medical Devices face in China.

Challenges in the approval of Medical Devices in China

We are certain that you are aware of the difficulties accompanied with the Medical Devices approval process. Besides obstacles like language and cultural barriers, manufacturers are often discouraged by many different factors such as:

  • The official structures and thus also the regulatory framework are constantly changing. For example, in 2018 the CFDA (China-FDA) was replaced by the NMPA (National Medical Medical Device Administration) and a new classification system was introduced.
  • There are many individual national GB and YY standards that come quickly, are changed and need to be taken into account.
  • It is requested that you disclose proofs and documents that reveal your Medical Device in depth.
  • Your Medical Devices must be re-tested in the national test centers. These tests are very specific, burdensome and time/cost intensive.
  • Many decisions from the authorities are accompanied by fruitful waiting times. Often their decisions are puzzling and are not always based on the applicable regulations

Our experts are well versed in the Chinese culture, national requirements, and the advantages and requirements of the new electronic Regulated Product Submission (eRPS). We are eager to help you to minimize queries from the authorities and enable you to reduce the time required for the approval of your Medical Devices

 

Our team is equipped with native speakers from China who can help you with difficult communications, clinical assessments, and life cycle or cybersecurity reports. Additionally, our Chinese experts know how to meet local requirements without revealing too much expertise.

Contact +49 451 808 503 60

EMEA

EMEA stands for Europe, Middle East and Africa and is the abbreviation for one of the three economic areas of the world. Unfortunately, the only thing the EMEA countries have in common is the same stock exchange trading time zone - one looks in vain for a uniform approval strategy for medical devices.

Approval of Medical Devices in Africa

Are you aware of the number of states that encompasses Africa? The continent comprises 54 states, of which, each, more or less are accompanied with its own rules for Medical Device registration. Nigeria is the largest economy in Africa with 448.1 billion USD and has clear requirements for registration. The Nigerian NAFDAC website offers their guidelines for download, but how is one expected to register a product in Algeria, Ethiopia or South Africa?

 

In many countries in the Middle East and Africa, the CE mark is sufficient to place Medical Devices on the market there. But slowly more and more countries are creating their own regulations. We are able to support you with market access in Africa and the Middle East.

Contact +49 451 808 503 60

Medical Device approval in the Middle East

Which countries exactly belong to the Near or Middle East can vary, depending on your point of view. Typically, and from a regulatory stance, countries such as the Arab Emirates or Israel are in any case highly intriguing and offer great potential for European Medical Device manufacturers. While Israel has a very well-developed medical technology sector, the Omar and Qatar rely primarily on imports from the EU.

Our expert knowledge for your worldwide market approval

We have in-depth expertise in the approval of Medical Devices - worldwide. From Europe to the Middle East and Africa to China and the Americas: Our experts know the respective country-specific requirements and regulations and are eager to support you with their know-how.

Contact +49 451 808 503 60

 

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