ANVISA certifies SyrhaTech’s medical device manufacturing system

The SyrhaTech teams are proud to announce that we have just obtained our ANVISA certification! This is a major milestone in the support we provide to our clients as part of our hydrogel prefilled syringe manufacturing activities.

Within SyrhaTech’s CDMO activities, the medical device manufacturing process must comply with numerous international standards and certifications. The hyaluronic acid–based products that we develop in R&D or manufacture for our clients fully meet these standards and comply with the commitments of this industry.

To tell us more about the ANVISA certification that SyrhaTech has just obtained, Marjorie interviewed SyrhaTech’s Quality Manager, Blandine Sauvage.

Discover their conversation below:

Marjorie: Hello Blandine, I’m delighted to speak with you today about SyrhaTech’s new ANVISA certification.

Blandine: Hello Marjorie, and thank you for inviting me.

Marjorie: Before we start with the first question, I’d like to briefly introduce you to our readers: you joined SyrhaTech in 2018 as Operations Manager, where you oversaw the Manufacturing, quality, supply, product transfer, and scientific support for R&D projects departments.

Blandine: Yes, that’s right. Then, in 2022, I became Quality Manager and took over responsibility for quality assurance and quality control for injectable medical devices (class III).

Marjorie: First question: can you explain what the ANVISA certification is and why it is important for a company like SyrhaTech?

Blandine: ANVISA is the Brazilian health authority, equivalent to the FDA in the United States or the EMA in Europe. Obtaining this certification means that our manufacturing system fully meets the quality, safety, and traceability requirements imposed for the production of medical devices intended for the Brazilian market.
For SyrhaTech, this recognition is strategic: it demonstrates that we are able to produce injectable product in accordance with the highest international standards.
This certification allows us to support our clients in developing their projects in a high-potential market such as Brazil, whether it involves dermal fillers manufacturing, orthopedic medical device development, or any other hyaluronic acid–based injectable product.

Marjorie: What motivated SyrhaTechto pursue this certification process?

Blandine: Our approach is driven by a dual ambition:

Marjorie: How did the certification process unfold, from preparation to final approval?

Blandine:
The process lasted several months and was structured around several key stages:

Marjorie: What were the main challenges encountered during this process?

Blandine:
The main challenge was to integrate the specific requirements of Brazilian regulations while maintaining our compliance with European standards and ISO 13485.
This required extensive documentation harmonization, as well as close coordination among all the teams involved in the project.
This project demanded rigor, precision, and strong commitment from everyone to align our practices with a new regulatory framework, all without compromising the continuity of our operations.

Several departments were actively involved in this certification process: Quality, Regulatory Affairs, Production, Management, and the entire Logistics chain.
The success of this certification relied heavily on coordination and collective effort, a great achievement we owe to all SyrhaTech employees who contributed, directly or indirectly, to this ANVISA certification journey.

Marjorie: Which specific ANVISA requirements required the most attention or adaptation from SyrhaTech?

Blandine: ANVISA stands out for its particularly high level of requirements regarding traceability and control of manufacturing processes. For SyrhaTech, as a medical device company and subcontracting manufacturer, this means being able to demonstrate compliance at all times, from the receipt of components to the final controls.
We therefore strengthened certain aspects of our production records, harmonized our quality practices, and refined our documentation tracking to ensure total transparency with both our clients and the authorities.
This level of rigor guarantees the reliability and reproducibility of our processes, in full alignment with regulatory expectations.

Marjorie: How does this certification strengthen SyrhaTech’s existing quality system for hydrogel prefilled syringe manufacturing?

Blandine: This certification reinforces the robustness of our quality system and validates our ability to meet the strictest regulatory requirements, regardless of the geographic region.
Our clients work with various product types such as dermal fillers or orthopedic medical device. Some have developed ophthalmic injectable product or oral tissue regeneration products.
For our clients, it is the assurance that their medical devices are manufactured according to high-level international standards, in a controlled environment compliant with ISO 13485.
Recognition by ANVISA illustrates the maturity of our organization and our continuous commitment to quality, safety, and compliance.

Marjorie: What opportunities does this certification open for Syrha, particularly in the Brazilian or international markets?

Blandine : Obtaining the ANVISA certification represents a genuine gateway to the Brazilian market.
It is one of the most dynamic and demanding markets in the world for medical devices, and one of the most promising in terms of dermal fillers and aesthetic products, for example.

For SyrhaTech, this certification brings strategic opportunities:

Beyond Brazil, this recognition also strengthens our credibility with other health authorities and consolidates our position as a trusted partner in medical device manufacturing for regulated market.

Marjorie: How does this achievement fit into SyrhaTech’s overall development strategy?

Blandine: This certification is fully aligned with our international development and market diversification strategy.
It reflects our ambition to support our clients’ global growth by offering them a manufacturing site that complies with the requirements of major health authorities.
Each new regulatory recognition, such as ANVISA’s, contributes to strengthening our reputation as a reliable, agile, and excellence-driven industrial partner.

Marjorie: What message would you like to share with our prospects regarding this success?

Blandine: This certification is above all the result of a collective commitment, the commitment to guarantee our clients medical devices manufactured in strict compliance with the most demanding global standards.
It symbolizes the rigor, expertise, and reliability of our teams, as well as the trust that our partners can place in SyrhaTech to support their international ambitions.
We are proud to contribute, through our industrial know-how, to the commercialization of safe and high-performance hydrogel prefilled syringe products that serve patients worldwide.

To our partners and prospects looking for a CDMO: choosing SyrhaTech means choosing trust, quality, and innovation, values that guide everything we do, wherever we operate in the world.

If you have a project or would like to meet our teams, please contact us