International Medical Device Standards

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Therapeutic Products Programme Holland Cross
1600 Scott Street
Tower B, 2nd Floor
Address Locator # 3102D1
Ottawa (Ontario)
K1A 1B6
May 4, 2000

To: Manufacturers and importers of medical devices, and other interested parties

Subject: Policy on the Canadian Assessment of Medical Devices Conformity System (CMDCAS)

You will find attached a policy that addresses the requirements of quality systems under Article 32 of the Medical Devices Regulations. It describes how the Therapeutic Products Programme (TPP) intends to apply these requirements and the methodology to be used to recognize a registrar as proficient to perform a conformity assessment system as a medical instrument manufacturer as ISO 13485 and ISO 13488 standards.

In December 1999, the PPT has released for public consultation a draft policy under Q16R16 name: Policy on CMDCAS. Following this consultation period of 30 days, the PPT has received numerous responses that have considered when preparing the final version of the policy on CMDCAS. The most important change made by the TPP involves the removal of the requirement for the Canadian incorporation registrars. This revision means that the PTT now recognize the ISO 13485 and 13488 certificates issued by foreign registrars, as these have been accreditated for the scope of accreditation on the CMDCAS by the Standards Council of Canada.

PTT is currently developing guidance documents relating to methodologies Registrar Accreditation and registration of quality systems of medical device manufacturers. These documents will be available in the coming months.

For more information about this policy, please contact:

Ms. Beth Peterson
Acting Director, Office of Medical Devices Statistics Main Room 1605 Tunney of Canada Building address 0301H1 Ottawa, Ontario K1A 0L2

Original signed by Mr. Dann
Michols Director General

cj

Therapeutic Products Programme Our ​​Mission: To ensure that drugs, medical devices and other therapeutic products available in Canada are safe, effective and of high quality.

Therapeutic Products Programme

CRC Press ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry
Book (CRC Press)
2008-07-25 18:05:46 by BiscuitCity

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