Articles

The Code exists to ensure that the advertising of therapeutic goods to the public is conducted in a manner that:
• Promotes the safe and effective use of therapeutic goods by minimising misuse, overuse or underuse
• Is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance
• Supports informed health care choices
• Is not inconsistent with relevant current public health campaigns

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Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

Medical Devices | United States of America

FDA’s unique device identification system is designed to adequately identify devices through distribution and use.Its requirements were designed to be phased in over seven years according to established compliance dates based primarily on device classification.

The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are:

· September 24, 2018, for the following requirements:
o Standard date formatting (21 CFR 801.18),
o Labeling (21 CFR 801.20, 21 CFR 801.50), and
o Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and
· September 24, 2020, for direct mark requirements (21 CFR 801.45).

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Tonometers – Premarket Notification [510(k)] Submissions

Medical Devices | United States of America

This guidance document identifies the classification regulation and product codes for tonometers. In addition, other sections of this guidance document provide additional information to manufacturers on addressing risks related to these devices in premarket notifications (510(k)s).

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Guide to Good Manufacturing Practice for Medicinal Products Annexes

Medicines Biologicals Herbal Cosmetic Nutra Medical Devices | PIC/S

This guideline describes the following points;

Annex 1 Manufacture Of Sterile Medicinal Products
Annex 2 Manufacture Of Biological Medicinal Substances And Products For Human Use
Annex 3 Manufacture Of Radiopharmaceuticals
Annex 4 Manufacture Of Veterinary Medicinal Products Other Than Immunologicals
Annex 5 Manufacture Of Immunological Veterinary Medical Products

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Guide to Good Manufacturing Practice for Medicinal Products (Part II)

Medicines Herbal Cosmetic Nutra Biologicals Medical Devices | PIC/S

This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.

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Guide to Good Manufacturing Practice for Medicinal Products (Introduction and Part I)

Medicines Biologicals Medical Devices Herbal Cosmetic Nutra | PIC/S

The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate, and do not place patients at risk due to inadequate safety, quality or
efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers, and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with
competent personnel, and suitable and sufficient premises, equipment, and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Authorised Person(s).

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Medical Device User Adverse Event Report Form

Medical Devices | Singapore

This article describes the medical device user adverse event report form.

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Dental Curing Lights – Premarket Notification [510(k)] Submissions

Medical Devices | United States of America

This guidance document identifies the classification regulations and product codes for dental curing lights. In addition, other sections of this guidance document provide additional information to manufacturers on addressing risks related to these devices in premarket notifications.

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ASEAN Registration of Pharmaceuticals for Human Use

This guideline describes the following attachments;

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Australia – Table of Contents

Advertising to the Public: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

Tonometers – Premarket Notification [510(k)] Submissions

Guide to Good Manufacturing Practice for Medicinal Products Annexes

Guide to Good Manufacturing Practice for Medicinal Products (Part II)

Guide to Good Manufacturing Practice for Medicinal Products (Introduction and Part I)

Medical Device User Adverse Event Report Form

Dental Curing Lights – Premarket Notification [510(k)] Submissions

ASEAN Registration of Pharmaceuticals for Human Use