Dental devices comprise of various types of implants, cusps, abutments, primers, crowns/bridges, procedural handpieces and many more. The implants are used in dentistry as artificial tooth root, which supports restorations that resemble a tooth or group of teeth to replace missing teeth. Dental implants serve as an ideal option for people who have lost a tooth or teeth due to unfortunate periodontal disease, an injury, or some accident.
Asia forms one of the most promising dental implant markets in the world. According to medical market research company Micro Market Monitor, the Asian dental implants market is mainly driven by aging population, high decayed, missing, and filled teeth (DMFT) index, and the growing incidence of oral cancer. Dental implants and their accessories have a growing market in Asia Pacific region, over the years. According to medical market research company iData Research, which published a new report this year on dental implants in the Asia Pacific, in 2021, the Asia Pacific dental implants market size is expected to reach nearly US$1.2 billion, with the India dental implant market demonstrating the highest growth. The titanium dental implants are the largest segment, with a share of nearly 97% in 2013, of the total dental implant material market.
Asian countries offer dental tour packages, which includes the cost of a dental treatment as well as a vacation, and is still lower than the total cost of a dental treatment incurred in the U.S.A and the U.K. This is luring more and more westerners to avail dental treatments in Asian countries, thereby rendering dental tourism a major source of revenue collection in the same.
An ongoing trend within the Australia, Japan and South Korea dental implant markets is the increasing movement towards digitization, resulting in high growth of the CAD/CAM abutments market. Through the use of CAD/CAM technology, dentists and laboratory technicians are able to increase productivity levels.
On the other hand, an ongoing trend within the Chinese dental implants market is the expanding network of private dental clinics within the country. Traditionally, a shortage of qualified dental professionals and services has contributed to the low penetration of dental implants in the country. Clinics and organizations offering restorative dental services are growing rapidly to meet local demand, and in some cases consolidating into larger chains.
Regulatory Requirements in Asian Countries
Dental devices range from low to high-risk classifications. Low risk classification devices such as dental impression casts and wax do not require submission of a detailed technical documentation. Devices such as dental primers, burs and implants typically fall under a moderately-high or high-risk classification, due to their level of invasiveness and duration of contact with living tissues. Hence, the amount of scrutiny the device’s technical documents receive with Authorities are just as high, especially for implantable dental devices.
- - Device Description
Registering dental devices in Asian countries would require almost similar set of technical documents. In the device description, Authorities recommend that manufacturers include a complete discussion of the performance specifications and when appropriate, detailed, labelled drawings of the device. They also recommend to include a description of device features, with dimensions and tolerances. Examples of features include anti-rotational feature, internal or external hexagonal features, flat axial surface features on implants, fins, threads or vertical anti-rotation slots.
In submissions for endosseous dental implants, Authorities recommend that characteristics of the abutment connection for each type and size of implants be included in the submission dossier. In all submissions, these characteristics should include platform size, shape and connection type.
- - Chemical and Physical Bench Tests
Generally, Authorities review whether the dental devices have typical international and local standards tested for such as fatigue test (ISO 14801), pull out test (ASTM F 543), corrosion test (ASTM F746-87) and shelf-life test (ASTM F-1980, ASTM F-1929, ASTM D 4992). Biocompatibility test reports, based on ISO 10993 and ISO 7405, are thoroughly reviewed to ensure the safety aspect of all raw materials used.
- - Biocompatibility Test and Material Safety Data Sheet
Material safety data sheet (MSDS) for each raw material used, along with biocompatibility test report, needs to be submitted for review. This includes chemical composition of major constituents and anticipated impurities, unless declaring conformance of a material’s standard. In certain cases, Authorities will insist for biocompatibility test report for the certain metals which are used as raw materials, albeit being a commonly used material and proven to be safe and stable, while others are open for alternatives. Eventually, it does come down to the Authorities’ discretion in allowing certain exemptions.
- - Risk Management Protocol and Report
Identified risks for failures and mitigation measures must be clearly described in the risk assessment/management protocol and report. This includes inadequate function or device failure (mobility, loss of integrity), damage to existing dentition, infection (local and systemic, including bacterial endocarditis), and injury during surgery, perforation and post-surgical parathesia.
- - Clinical Studies
Clinical investigation ordinarily should include a randomized, well-controlled clinical trial designed to demonstrate the safety and performance of the device when used as described in the Intended Use statement. This remains one of the major requirements in regulatory evaluation of dental devices and inadequacy to prove the device’s intended use claims or safety and performance in the clinical evaluation report, will result in issues during evaluation.
As dental device market continues to dazzle as a fast-growing medical device market in Asia, we may help you seize the opportunity to enter this market by registering your medical devices, as well as assisting you to connect with local distributors – ultimately, leading you to a smooth journey towards the expansion of your products into Asia. Feel free to contact one of our consultants today!