Proposal of Standard for Good Manufacturing Practices Medical Devices

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Photo credit: AMD medical devices & Cisco telehealth collaboration by Cisco Australia-NewZealand

Commission for Protection against Sanitary Risks (COFEPRIS) has proposed a new standard (NOM) for ruling the premises where medical devices are manufactured. This proposal of NOM is set for comments of interested parties until January 12, 2012.

Mexican Law has set “Good Manufacturing Practices” for several products of the pharmaceutical and cosmetic industry. Now it is time for this type of premises.

The proposal affects design, construction and facilities of premises used for manufacturing medical devices, as well as qualifications personnel and general documentation needed for operation of such premises.

The devices affected are medical equipment, prosthesis, diagnosis agents, dental consumables, material of any type including surgical, healing and hygienic.

Consultation proceedings for proposal of NOM is a proceeding authorized under Mexican Law for authorities to consider comments from interested parties.

In other words, it a valid manner to influence regulation for your industry. If you are interested in that kind of lobbying, drop me a line, I have been through that path before. 

About the author

Alberto Esenaro

I am a Mexican lawyer with experience in technology, energy, automotive, infrastructure and business. Worked for law firms, international companies and Government bodies on business advice, regulatory compliance and litigation.

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By Alberto Esenaro

About Author

Alberto Esenaro

I am a Mexican lawyer with experience in technology, energy, automotive, infrastructure and business. Worked for law firms, international companies and Government bodies on business advice, regulatory compliance and litigation.

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