Medical Device Certification

The Japanese regulatory process was revised in 2004, creating the Pharmaceutical and Medical Devices Agency (PMDA), and provisions relating to medical devices came into effect on April 1, 2005 [16], In Japan two submissions may be required a KIT Drug J-NDA submission and a separate Medical Device Certification the latter of these has to be filed with PMDA. It should be noted that the review timelines for KIT Drug and Medical Device Certification submissions... 

The designated notified body regulates CE marking and the final result of all the certification process (Fig. 9.2) is the achievement of a certificate of conformity that enables the mannfacturer to apply a CE marking to the product. A CE mark is a guarantee of medical device certification and registration and enables access to the entire EU market (European Commission, 2012). 

Fig. 9.2 Regulatory process for medical devices certification in Europe.

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Medical grade plastics are discussed with reference to biocompatibility and the tests that the end-product manufacturer should perform in order to ensure the safety of the material. Regulatory requirements are described, and tabulated data is presented on mostly European suppliers of medical grade plastics. The data shows that most companies rely onUSP Class VI certificates to demonstrate the suitability of their materials for the medical industry. However, it is argued that most manufacturers of medical devices would benefit more from tests carried out according to ISO 10993. 6 refs. 

A MRA on standards and conformity assessment between Australia and the EC came into effect from 1999, covering eight industry sectors including GMP inspection and batch certification of medicinal products, and conformity assessment of medical devices. 

The ECMRA applies to medical devices manufactured in the EC, Australia and New Zealand. It recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements, and the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification (CE Marking) for entry onto the EC market. 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

Failure to include the required certifications in submissions can result in an application being refused for filing. In addition, NDAs and BLAs require the submission of auser fee form 3397 indicating that the fee has been submitted in the amount as required. Table 1 provides a matrix of the certifications required for drug, biologic, and medical device applications. 

Certification that a reasonable search of all information and other similar legally marketed medical devices has been conducted. 

These guidelines were originally developed for testing the suitability of plastics used in medical devices that may come into contact with bodily fluids, but they have been extended to adhesives as well. Generally, products are tested by an independent laboratory. The results are typically provided to device or adhesive manufacturers in the form of certifications of compliance on an as-requested basis. Meeting these standards verifies that the successfully tested products are nontoxic and biologically inert in the cured state. 

Table II Permanently listed color additives subject to US certification in 2002, excluding those approved exclusively for use in medical devices.

Designate, establish and approve quality specifications with respect to food, drugs, cosmetics, medical devices, bottled water and chemicals necessary for their certification. 

Negative certification The importer must certify that all of the chemicals in the imported product are not subject to TSCA and are regulated under another statute. A negative certification is generally required for imports of pesticides (but not pesticide intermediates), nuclear materials, firearms and ammunition, food, food additives, drugs, registered pesticides, cosmetics, or medical devices. 

The company store. Additional benefits with readily calculated dollar values come from the stores operated by large pharmaceutical companies. The companies make their own products available at substantial discounts to employees. Not only prescription drugs but over-the-coimter remedies, cosmetics, medical devices, and eye-care products are stocked. Other establishments that serve employees occupy company premises and include hair salons and credit unions. With nearly all the services of commercial banks, credit unions offer competitive interest rates for automobile loans, mortgages, checking and saving accounts, and certificates of deposit. 

Reguiatay FDA 21 CFR 73.3107, exempt from certification, permanently listed for use in medical devices ManufJDistrib. Albion Colours Ltd Sinochem Jiangsu Wuxi Trade Names Ponolith Supra Violet EB Liq. 

Certification and approvals are statements by an impartial accredited body that a product or service fulfills specific requirements, such as directives and standards. Certification may be mandatory, as is the case for some regulated products (Annex IV machines, telecom, medical devices, etc.), or voluntary as Is the case for most product and machine categories. Manufacturers often seek voluntary certification to assure themselves, customers, and authorities that their products meet the requirements set by law. Certification is commonplace in Europe and allows the use of a distinctive approval mark affixed to the product that is backed by a certificate and test report. The approval mark, is a recognized quality mark attesting to a products conformity to the relevant requirements, such as for EMC and safety. 

Regulatory FDA 21CFR 73.1125, 73.2125, 73.3110 exempt from certification, permanently listed for drug use and medical devices Manuf./Distrib. AB R Lundberg Aldrich http //www.sigma-aldrich.com, Alfa Chem http //www.aifachem.homepage.com, Anmar Int l. http //WWW. anmarinternationai. com, Asiamerica Int l. 

Regulatory FDA 21 CFR 72.2327, 73.1327, 178.3297 exempt from certification, permanently listed for drug use and medical devices... 

---