Regulatory control: the health sector and its regulations
In the case of the manufacture of medical devices, the requirements will normally be higher than for other types of products. Obviously, this status is produced by the impact that this type of product has on people’s health, and the personal damage that can occur, in addition to material damage, in the event that a medical device does not meet any of the requirements or expectations indicated.
For this reason, although all companies that market products in international markets are subject to compliance with different regulations, in the case of companies in the health sector the requirements are usually stricter.
Regulatory control is governed on the basis of national or international legislation, which is supervised by different control entities. In addition, their objective is to ensure that all products marketed in the countries within their scope meet the requirements of the applicable laws or regulations.
What are the regulatory bodies in different regions of the world?
Every country has an agency whose main objective is the control of the medical device. In the case of Spain, the Spanish Agency for Medicines and Health Products (AEMPS) is in charge of this control, and each of the countries of the European Union has a similar body.
In regions of the world other than Europe, this advantage does not exist, and medical device manufacturers have to ensure that they meet the specific requirements of each of the countries in which they market their products.
While it is true that the tendency is for there to be some uniformity or equivalence in the requirements of the different regulatory bodies, each country may have its own particularities or different requirements, so manufacturers must be sure to comply with the requirements established for each country.
Among all the regulatory agencies, it is of particular interest to consider compliance with the requirements established by the U.S. regulatory agency, the FDA.
There are several reasons for this. On the one hand, the US market in the healthcare sector is in high demand, which makes it of special interest to any manufacturer. On the other hand, the medical sector in this country is among the most advanced in the world, and among the most demanding in terms of products.
As a result, the requirements established by the FDA to allow the marketing of medical devices in the country are very complete and exhaustive.
Requirements for marketing medical devices in the U.S.
One of the most important requirements that medical device manufacturers must meet is obtaining FDA approval before they can sell their products in the U.S. market.
FDA approval involves the submission of sound clinical data demonstrating the safety and efficacy of the product in question. Currently, the FDA has a premarket review process for medical devices that can take between 90 and 180 days.
In addition, the FDA also requires medical device manufacturers to comply with several rules and regulations set forth in the Food, Drug and Cosmetic Act of 1938 and the Food, Drug and Cosmetic Act Amendments Act of 1962. These regulations set standards for the manufacture, packaging, labeling and marketing of medical devices.
Another important requirement for medical device manufacturers is the implementation of a quality system that complies with the Good Manufacturing Practice (GMP) standards established by the FDA.
GMPs are international standards that ensure the quality and consistency of medical devices during manufacturing. Manufacturers that do not comply with these standards can face sanctions, including product recalls.
Regulatory control at Biovac
Biovac, not being a medical device manufacturer, is not directly subject to compliance with the regulatory requirements established by the different organizations. This does not imply, however, that it does not have to comply with regulatory control in the form of strict protocols in its process, due to the importance that its finishes have on the properties of the implant.
In general, the porous coating processes in surgical implants that Biovac performs by means of vacuum sintering or plasma thermal projection techniques are fundamental to guarantee the osseointegration processes and the adherence of the implant to the bone.
Considering the previous point, Biovac is considered as a critical supplier by the manufacturers of medical devices. In other words, it is subject to special scrutiny by its customers and by certifying and regulatory bodies.
To ensure that the coatings Biovac applies are suitable for surgical implants, it is important to comply with a number of international quality standards for surgical implant coatings.
As with medical devices in general, the selection of the applicable standards for porous implant coatings depends on the country or region in which they will be used, as well as the specific medical application.
In addition to compliance with all applicable regulations, Biovac has to guarantee its customers a very clear objective: it is able to maintain the quality standards of its production process over time.
To demonstrate this ability, the company is certified by an internationally recognized independent body (SGS) for ISO 9001, applicable to quality management systems, and ISO 13485, specific to medical device quality systems.
When a Biovac customer has to justify to a certifying or regulatory control body the compliance with all the requirements applicable to its implant, it will have to justify among them the properties that the applied coating complies with.
This process ensures close collaboration between Biovac and the customer, providing all the necessary documents or validation tests to complete the product dossier to be submitted to the corresponding entity.
In the case of the FDA, there is a mechanism that allows the coating manufacturer to submit a validation document in advance.
The Master File (MAF) is a document that gathers all the validation tests required by the FDA for implant coatings. The implant manufacturer can reference the MAF number provided by Biovac in their Premarket Notification 510(k) or Premarket approval (PMA) application, and all documentation contained in the document will be incorporated into their application for consideration by the FDA.
In order to facilitate this task for its customers, Biovac has submitted to the FDA three different Master Files, related to Ti plasma coating, HA plasma coating, and sintered porous coating, which can be attached to the rest of the FDA documentation upon request by the customer.
Do you need more info?
Contact us if you have any questions or want more information about porous coatings. 360º, personal and exclusive attention.