MDSAP Certification　　
What is MDSAP certification?　　

Medical Device Single Audit Program (MDSAP) is a project sponsored by members of the international medical device regulators Forum (IMDRF). It is designed to meet the different QMS/GMP requirements of the participating countries with a single audit of the medical device manufacturer by a qualified third party audit organization.

This project has been endorsed by five regulatory agencies, the US Food and Drug Administration (FDA), Health Canada Health Canada, the Australian Therapeutic Goods Administration (TGA), the Brazilian health agency( ANVISA), and Japanese Ministry of health, labour and welfare (MHLW), and January 1, 2017, that positively implement the MDSAP and mutually recognize the inspection results. Currently, China and the EU join the project in observer status, as does the WHO.

What is the relationship between ISO13485 and ISO14971 and MDSAP?

ISO13485 is the basis of MDSAP, MDSAP requirements are higher than/more than ISO13485 requirements; Although the MDSAP regulations do not incorporate the ISO14971 requirements, the Certification Checklist (MDSAP public document) has incorporated the ISO14971 standard content into the details of the audit requirements, thus reflecting the importance of risk management standards and the necessity for the implementation of risk management systems. In addition to the requirements of ISO13485 and ISO14971 standards, MDSAP also has the regulatory requirements of each participating country;

What can NCE do for you?

Assist businesses in establishing medical device quality management system as per MDSAP

Assist the enterprise to meet the requirements of MDSAP on the original QMS

Integrate the quality management system of enterprises and meet the requirements of regulations in each country

Provision of MDSAP specific training services

Provide MDSAP special pre-audit service

Providing MDSAP review site accompanied services

Can MDSAP be a complete substitute for the review by competent authorities in participating countries?

A: recognition of an MDSAP review result does not imply a waiver of its regulatory authority by the competent authority and, when deemed necessary by the competent authority, can still be reviewed. The degree of endorsement by the relevant countries is as follows:

US: a substitute for FDA's routine inspections, excluding FDA specific and PMA products

Canada: mandatory replacement of CMDCAS from 2019 as a route to Canada for products classified in class II and above

Australia: exempt TGA audits, support issuing and maintaining TGA certificate of compliance audits

Brazil: For class III and class IV medical devices, it may replace ANVISA's premarket GMP inspections, as well as post marketing routine inspections (which do not contain specialized inspections)

Japan: for class II, III, and IV medical devices, an on-site plant review may be exempted;

 

European CE Certification　　
CE Certification Service

1. Introduction to CE certification

According to the different classification of medical device products, the European Union has successively issued 3 directives concerning medical device products, by which Harmonizing regulatory practices for medical device products in European countries. The above regulations must be followed for medical device producers in countries around the world to want their own products into the European market. Domestic producers who wish to develop a European market must acquire the CE mark of the EU, which is also an qualification to obtain export of medical device products to the EU market.

These 3 directives regarding access to medical device products are: active implantable medical device directive (AIMDD, 90 / 335 / EEC), medical device directive (MDD, 93 / 42 / EEC), and in vitro diagnostic device directive (IVDD, 98 / 79 EEC). Among the above 3 directives, taking the 2nd directive (MDD) as the one with the widest scope of application, almost all exported medical device products, such as hygiene materials and medical dressings, medical catheters, ventilators, various types of endoscopes, and patient monitors, are included.

As of 26 may 2020, the three-year transition period in the medical device regulations (MDR) ends and old directives 93 / 42 / EEC and 90 / 335 / EEC, above, will be mandatorily replaced. Beginning on May 26, 2022, the five-year transition period to the in vitro diagnostic device regulation (IVDR) ends and the old Directive 98 / 79 / EEC will be imposed to replace it.

2. Establishment and mentoring of the CE certification quality system

3. Counseling on CE technical document preparation

4. CE certification clinical evaluation

5. CE certification assistance application

　　
FDA Certification　　
1. Introduction to FDA Certification

FDA is short for food and drug administration. The FDA is the international medical review authority, authorized by the US Congress, the federal government, and is the top enforcement authority involved in the regulation of foods, drugs, medical devices, radiation emitting products, vaccines, blood and biological products, products for animal and veterinary use, cosmetics, and tobacco products.

The administration of medical devices by the FDA is conducted through the center for devices and radiological health (CDRH), which centrally regulates the production, packaging, dealers' compliance with the law to conduct operational activities. There is a wide range of medical devices, ranging from small for medical gloves to large for cardiac pacemaker, which are under the FDA oversight and are classified into categories I, II, and III based on medical uses and possible injuries to humans, with higher regulatory stringency.

The 513(g) Request is a quick and effective way to obtain FDA information on product classification and applicable regulatory requirements for products where the classification is unclear or where existing classification is in doubt. FDA will provide the following information in its response: (1) product subordinate product type; (2) Product classification; (3) Suitable product registration pathways; (4) Other applicable requirements; (5) Applicable product guideline document; (6) FDA additional requirements.

2. Establishment and mentoring of the FDA cerfication quality system (QSR820)

3. 510k technical document preparation guidance

4. Assist product inspection

 

HC Certification of Canada

Canada classifies medical devices into categories ⅰ, ⅱ, ⅲ and ⅳ, with category ⅰ having the lowest risk and Category ⅳ having the highest risk. According to the size of the risk, product registration requirements are increased step by step, quality system requirements are also more detailed.

When the Canadian medical device authority implements the registration of medical device products, it combines the third-party quality management system review, namely, when the class ⅱ, ⅲ and ⅳ device manufacturers apply for registration, It is required to submit a Medical device quality management system certification certificate issued by a third party organization recognized by Canadian Medical Device Certification and Accreditation Agency (NCECAS), namely CAN/CSA-ISO 13485 system certificate.