International regulation

News of medical device global

We try to summerise most critical regulatory news here in free basis which impacts product registration.

For a detailed regulatory radar you can contact us to book your markets.

FDA makes Final Rule Amending the Quality System Regulation. See theamendments.

Canada has a draft guidance in term of "significant change". Study the beautiful 10 changes types, it is good example for change assessment in global market.

Taiwan authority has a unique collection of all important regulation and notification of medical device in a 235-page PDF.

[Medical Device Management Act]

[Implementation Rules of the Medical Device Management Act]

[Measures for the Classification and Grading Management of Medical Equipment]

[Measures for the Management of Medical Equipment Technicians]

[Measures for the establishment and management of source and flow data of medical equipment]

[Medical device manufacturers set standards]

[Medical Device Quality Management System Guidelines]

[Measures for Inspection of Medical Device Quality Management System and Issuance of Manufacturing License]

[Criteria for Contracted Manufacturing of Medical Devices]

[Good Shipping and Marketing Guidelines for Medical Devices]

[Measures for the inspection and issuance of quality transportation and sales licenses for medical devices]

[Criteria for issuance and registration of medical device licenses and annual declaration]

[Methods for approved manufacturing and import of specific medical equipment projects]

[Measures for the Management of Excellent Clinical Trials of Medical Devices]

[Measures for the Safety Surveillance and Management of Medical Equipment]

[Measures for Notifying Serious Adverse Events of Medical Devices]

[Measures for border random inspection and inspection of imported medical equipment]

[Methods for recycling and disposal of medical equipment]

[Medical equipment administrative fee charging standards]

[Measures for the appointment or entrustment of medical device inspection]

[Measures for the Management of Certification and Entrusted Certification of Medical Equipment Inspection Agencies]

[Measures for the entrustment of medical device management matters and the certification of entrusted institutions]

[Incentive Measures for Medical Equipment Innovation and Technology Research and Development]

[Medical device dealers (pharmacies) that set up separate medical device vending machines are exempt from applying for separate business premises sales business licenses]

[The scope and types of medical equipment retail business that pharmacies may concurrently engage in]

[Items of medical equipment sold through communication trading channels and matters that should be followed]

[Types of medical equipment sold by vending machines and matters that should be followed when selling them]

[Medical equipment for which source and flow data should be established and maintained, and medical equipment items for which source and flow data should be reported]

[Items exempt from obtaining medical device manufacturing license]

[Article 24 of the Medical Device Management Act: Medical device items and their sellers who should establish an excellent distribution and sales system for medical devices]

[Medical device items that should obtain marketing authorization through login]

[Specifications, inspection methods and performance that specific medical equipment items should comply with]

[Medical device labels, instructions or packaging are exempt from the manufacturing date, validity period, or shelf life requirements]

[Warnings and precautions should be included on labels, instructions or packaging of specific medical devices]

[In accordance with the provisions of Article 25, Paragraph 4 of the Medical Device Management Act, the central competent authority shall directly register and cancel the original license, and relevant provisions on product labels, instructions or packaging]

[Requirements that medical device labels should carry a single identification code]

[Matters that should be added to medical equipment items and their labels or packaging that require electronic instructions to replace Chinese instructions]

[Clinical trial format of medical devices without significant risks]

[Except for daily wear daily disposable contact lenses, advertisements for other contact lenses must be published in medical publications, communication tools exclusively for medical personnel, or medical academic related activities exclusively for medical personnel to participate]

[Medical equipment items that should be subject to safety surveillance]

[Those who use medical equipment to collect, process or utilize personal information shall replace written consent]

a. MDR transition

Do you follow the policy of MDR transition extension in Australian government? It is worthy to have a plan of MDD products for European manufacturer.

b. Leverage of existing certificte

1. UK recognises international approval of medical device in some markets:

AustraliaTherapeutic Goods Administration (TGA)
Canada Health Canada
European Union (EU) National competent authorities in the member states of the EU/ European Economic Area (EEA)
United States of America (USA) Food and Drug Administration (FDA)

see our post in linkedin.

2. The similar draft of leveraging regulatory authorisation (IN 290/2024) occurs in Brazil too.

c. IMDRF published new